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pdfInformation Collection Domain: Pre-Transplant Information Collection
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
no
no
Sequence Number:
Auto Filled Field
Sequence Number:
Auto Filled Field
no
no
Date Received:
Auto Filled Field
Date Received:
Auto Filled Field
no
no
CIBMTR Center Number:
Auto Filled Field
CIBMTR Center Number:
Auto Filled Field
no
no
EBMT Code (CIC):
Auto Filled Field
EBMT Code (CIC):
Auto Filled Field
no
no
CIBMTR Research ID:
Auto Filled Field
CIBMTR Research ID:
Auto Filled Field
no
no
Event date:
Auto Filled Field created with CRID
Event date:
Auto Filled Field created with CRID
no
no
Date of birth:
YYYY/MM/DD
Date of birth:
YYYY/MM/DD
no
no
Sex
Sex
female,male
no
no
Ethnicity
female,male
Hispanic or Latino,Not applicable (not a
resident of the USA),Not Hispanic or
Latino,Unknown
Ethnicity
Hispanic or Latino,Not applicable (not a resident
of the USA),Not Hispanic or Latino,Unknown
Race (check all that apply)
American Indian or Alaska Native,Asian,Black or
African American,Not reported,Native Hawaiian or
Other Pacific Islander,Unknown,White
Race detail (check all that apply)
African American,African (both parents born in
Africa),South Asian,American Indian, South or
Central America,Alaskan Native or Aleut,North
American Indian,Black Caribbean,Caribbean
Indian,Other White,Eastern European,Filipino
(Pilipino),Guamanian,Hawaiian,Japanese,Korean,
Mediterranean,Middle Eastern,North
American,North Coast of Africa,Chinese,Northern
European,Other Pacific Islander,Other
Black,Samoan,Black South or Central
American,Other Southeast
Asian,Unknown,Vietnamese,White
Caribbean,Western European,White South or
Central American
no
no
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Race (check all that apply)
Race detail (check all that apply)
American Indian or Alaska
Native,Asian,Black or African
American,Not reported,Native Hawaiian
or Other Pacific Islander,Unknown,White
African American,African (both parents
born in Africa),South Asian,American
Indian, South or Central America,Alaskan
Native or Aleut,North American
Indian,Black Caribbean,Caribbean
Indian,Other White,Eastern
European,Filipino
(Pilipino),Guamanian,Hawaiian,Japanese
,Korean,Mediterranean,Middle
Eastern,North American,North Coast of
Africa,Chinese,Northern European,Other
Pacific Islander,Other
Black,Samoan,Black South or Central
American,Other Southeast
Asian,Unknown,Vietnamese,White
Caribbean,Western European,White
South or Central American
Rationale for Information Collection Update
Page 1 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
no
no
no
no
no
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response
Andorra,United
Arab Option(s)
State of residence of recipient
Element Response
Information Collection update:
Andorra,United
Arab Option(s)
Emirates,Afghanistan,Antigua and
Barbuda,Anguilla,Albania,Armenia,Neth
erlands
Antilles,Angola,Antarctica,Argentina,Am
erican
Samoa,Austria,Australia,Aruba,Aland
Islands,Azerbaijan,Bosnia and
Herzegovina,Barbados,Bangladesh,Belgi
um,Burkina
Faso,Bulgaria,Bahrain,Burundi,Benin,Sai
nt Barthelemy,Bermuda,Brunei
Darussalam,Bolivia,Bonaire, Sint
Eustatius and
Saba,Brazil,Bahamas,Bhutan,Bouvet
Island,Botswana,Belarus,Belize,Canada,C
ocos (Keeling) Islands,Congo, Democratic
Republic of the,Central African
Republic,Congo, Republic of
the,Switzerland,Cote d'Ivoire,Cook
Islands,Chile,Cameroon,China,Colombia,
Costa Rica,Cuba,Cape
Verde,Curacao,Christmas
Island,Cyprus,Czech
Republic,Germany,Djibouti,Denmark,Do
minica,Dominican
Republic,Algeria,Ecuador,Estonia,Egypt,
Western
Sahara,Eritrea,Spain,Ethiopia,Finland,Fiji
Acre,Alagoas,Amapa,Amazonas,Bahia,Ce
ara,Distrito Federal,Espirito
Santo,Goias,Maranhao,Mato
Grosso,Mato Grosso do Sul,Minas
Gerais,Para,Paraiba,Parana,Pernambuco
,Piaui,Rio Grande do Norte,Rio Grande
do Sul,Rio de
Janeiro,Rondonia,Roraima,Santa
Catarina,Sao Paulo,Sergipe,Tocantins
Province or territory of residence of
recipient
Alberta,British Columbia,Manitoba,New
Brunswick,Newfoundland and
Labrador,Nova
Scotia,Nunavut,Northwest
Territories,Ontario,Prince Edward
Island,Quebec,Saskatchewan,Yukon
no
State of residence of recipient
Alaska,Alabama,Arkansas,Arizona,Califor
nia,Colorado,Connecticut,District of
Columbia,Delaware,Florida,Georgia,Haw
aii,Iowa,Idaho,Illinois,Indiana,Kansas,Ke
ntucky,Louisiana,Massachusetts,Marylan
d,Maine,Michigan,Minnesota,Missouri,
Mississippi,Montana,North
Carolina,North Dakota,Nebraska,New
Hampshire,New Jersey,New
Mexico,Nevada,New
York,Ohio,Oklahoma,Oregon,Pennsylvan
ia,Rhode Island,South Carolina,South
Dakota,Tennessee,Texas,Utah,Virginia,V
ermont,Washington,Wisconsin,West
Virginia,Wyoming
State of residence of recipient
Alaska,Alabama,Arkansas,Arizona,California,Color
ado,Connecticut,District of
Columbia,Delaware,Florida,Georgia,Hawaii,Iowa,I
daho,Illinois,Indiana,Kansas,Kentucky,Louisiana,M
assachusetts,Maryland,Maine,Michigan,Minnesot
a,Missouri,Mississippi,Montana,North
Carolina,North Dakota,Nebraska,New
Hampshire,New Jersey,New Mexico,Nevada,New
York,Ohio,Oklahoma,Oregon,Pennsylvania,Rhode
Island,South Carolina,South
Dakota,Tennessee,Texas,Utah,Virginia,Vermont,W
ashington,Wisconsin,West Virginia,Wyoming
no
NMDP Recipient ID (RID):
open text
NMDP Recipient ID (RID):
open text
no
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Country of primary residence
Country of primary residence
Emirates,Afghanistan,Antigua and
Barbuda,Anguilla,Albania,Armenia,Netherlands
Antilles,Angola,Antarctica,Argentina,American
Samoa,Austria,Australia,Aruba,Aland
Islands,Azerbaijan,Bosnia and
Herzegovina,Barbados,Bangladesh,Belgium,Burkin
a Faso,Bulgaria,Bahrain,Burundi,Benin,Saint
Barthelemy,Bermuda,Brunei
Darussalam,Bolivia,Bonaire, Sint Eustatius and
Saba,Brazil,Bahamas,Bhutan,Bouvet
Island,Botswana,Belarus,Belize,Canada,Cocos
(Keeling) Islands,Congo, Democratic Republic of
the,Central African Republic,Congo, Republic of
the,Switzerland,Cote d'Ivoire,Cook
Islands,Chile,Cameroon,China,Colombia,Costa
Rica,Cuba,Cape Verde,Curacao,Christmas
Island,Cyprus,Czech
Republic,Germany,Djibouti,Denmark,Dominica,Do
minican
Republic,Algeria,Ecuador,Estonia,Egypt,Western
Sahara,Eritrea,Spain,Ethiopia,Finland,Fiji,Falkland
Islands,Micronesia,Faroe
Islands,France,Gabon,United Kingdom (England,
Wales, Scotland, Northern
Ireland),Grenada,Georgia,French
Guiana,Guernsey,Ghana,Gibraltar,Greenland,Gam
bia,Guinea,Guadeloupe,Equatorial
Guinea,Greece,South Georgia and the South
State of residence of recipient
Acre,Alagoas,Amapa,Amazonas,Bahia,Ceara,Distrit
o Federal,Espirito Santo,Goias,Maranhao,Mato
Grosso,Mato Grosso do Sul,Minas
Gerais,Para,Paraiba,Parana,Pernambuco,Piaui,Rio
Grande do Norte,Rio Grande do Sul,Rio de
Janeiro,Rondonia,Roraima,Santa Catarina,Sao
Paulo,Sergipe,Tocantins
Province or territory of residence of
recipient
Alberta,British Columbia,Manitoba,New
Brunswick,Newfoundland and Labrador,Nova
Scotia,Nunavut,Northwest
Territories,Ontario,Prince Edward
Island,Quebec,Saskatchewan,Yukon
Rationale for Information Collection Update
Page 2 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
no
Zip or postal code for place of recipient's
residence (USA and Canada residents only): open text
yes
no
Has the recipient signed an IRB / ethics
committee (or similar body) approved
consent form to donate research blood
samples to the NMDP / CIBMTR (For
allogeneic HCTs only)?
Has the recipient signed an IRB /
ethics committee (or similar body)
approved consent form to donate
No (recipient declined),Not applicable (center not
research blood samples to the NMDP participating), Not approached,Yes (recipient
/ CIBMTR (For allogeneic HCTs only)? consented)
yes
no
Related Donors
yes
Related Donors
yes
no
Allogeneic
Recipient
Allogeneic
Recipient
Clinical Trial
Participants
Clinical Trial
Participants
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Clinical Trial
Participants
Clinical Trial
Participants
Clinical Trial
Participants
Autologous
Transplant
Autologous
Transplant
No (recipient declined),Not applicable
(center not participating), Not
approached,Yes (recipient consented)
YYYY/MM/DD
no
Date form was signed:
Did the recipient submit a research
sample to the NMDP/CIBMTR
repository? (Related donors only)
no
Research sample recipient ID:
Research sample recipient ID:
Is the recipient participating in a
clinical trial? (clinical trial sponsors
that use CIBMTR forms to capture
outcomes data)
open text
open text
no,yes
BMT CTN,COG,Other,PIDTC,RCI
BMT,USIDNET
no,yes
BMT CTN,COG,Other,PIDTC,RCI BMT,USIDNET,
PedAL
no
Study Sponsor
yes
no
Specify other sponsor:
yes
no
Study ID Number
yes
no
yes
no
Subject ID:
open text
Specify the ClinicalTrials.gov identification
number:
open text
yes
no
Is a subsequent HCT planned as part of the
overall treatment protocol? (not as a
reaction to post-HCT disease assessment)
(For autologous HCTs only)
no,yes
Subject ID:
open text
Specify the ClinicalTrials.gov
identification number:
open text
Is a subsequent HCT planned as part
of the overall treatment protocol?
(not as a reaction to post-HCT
disease assessment) (For autologous
HCTs only)
no,yes
yes
no
Specify subsequent HCT planned
Specify subsequent HCT planned
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Allogeneic,Autologous
Study Sponsor
no,yes
yes
open
text
A Representative
list of current
response options is shown here. This list
will change on a frequent basis to
accommodate updates – changes in the
response options do not affect burden of
completing this question. BMT CTN 0301
- Aplastic Anemia,BMT CTN 0601 - Sickle
Cell Anemia,BMT CTN 0701 - Follicular
Lymphoma,BMT CTN 0702 Myeloma,BMT CTN 0801 - Chronic GVHD
Treatment,BMT CTN 0803 - Auto HCT in
HIV + Patients,RCI BMT 09 - MRD,RCI
BMT 09 - Plex,BMT CTN 0901 Myeloablative vs. RIC,BMT CTN 0902 Peri-TX Stress Mgmt,BMT CTN 0903 Allo HCT in HIV + Patients,RCI BMT 10 CBA,RCI BMT 10-CMSMDS-1,RCI BMT 11 Treo,BMT CTN 1101 - Haplo vs. Double
UCB with RIC,BMT CTN 1102 - MDS in
older patients,RCI BMT 12 - Moxe,BMT
CTN 1202 - Biomarker,BMT CTN 1203 GVHD Prophylaxis,BMT CTN 1204 HLH,BMT CTN 1205 - Easy-to-read
Consent Form (ETRIC),RCI BMT 13 TLEC,BMT CTN 1301 - CNI-Free,BMT CTN
1302 - Allo MM,BMT CTN 1401 Myeloma Vaccine,RCI BMT 145-ADS202,RCI BMT 15 - MMUD,BMT CTN 1501
- Standard Risk GVHD,BMT CTN 1502 -
Change/Clarification of Response Options
Specify other sponsor:
Study ID Number
Rationale for Information Collection Update
open text
Date form was signed:
YYYY/MM/DD
Did the recipient submit a research sample
to the NMDP/CIBMTR repository? (Related
donors only)
no,yes
Is the recipient participating in a clinical
trial? (clinical trial sponsors that use
CIBMTR forms to capture outcomes data)
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Current Information Collection Data
Element (if applicable)
Zip or postal code for place of
recipient's residence (USA and
Canada residents only):
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Be consistent with current clinical landscape, improve
transplant outcome data
open
text
A Representative
list of current response options
is shown here. This list will change on a frequent
basis to accommodate updates – changes in the
response options do not affect burden of
completing this question.BMT CTN 0301 - Aplastic
Anemia,BMT CTN 0601 - Sickle Cell Anemia,BMT
CTN 0701 - Follicular Lymphoma,BMT CTN 0702 Myeloma,BMT CTN 0801 - Chronic GVHD
Treatment,BMT CTN 0803 - Auto HCT in HIV +
Patients,RCI BMT 09 - MRD,RCI BMT 09 - Plex,BMT
CTN 0901 - Myeloablative vs. RIC,BMT CTN 0902 Peri-TX Stress Mgmt,BMT CTN 0903 - Allo HCT in
HIV + Patients,RCI BMT 10 - CBA,RCI BMT 10CMSMDS-1,RCI BMT 11 - Treo,BMT CTN 1101 Haplo vs. Double UCB with RIC,BMT CTN 1102 MDS in older patients,RCI BMT 12 - Moxe,BMT
CTN 1202 - Biomarker,BMT CTN 1203 - GVHD
Prophylaxis,BMT CTN 1204 - HLH,BMT CTN 1205 Easy-to-read Consent Form (ETRIC),RCI BMT 13 TLEC,BMT CTN 1301 - CNI-Free,BMT CTN 1302 Allo MM,BMT CTN 1401 - Myeloma Vaccine,RCI
BMT 145-ADS-202,RCI BMT 15 - MMUD,BMT CTN
1501 - Standard Risk GVHD,BMT CTN 1502 CHAMP Aplastic Anemia,BMT CTN 1503 STRIDE2,BMT CTN 1506 - AML Maintenance
Therapy,BMT CTN 1507 - Haplo Sickle Cell,RCI BMT
16-CMS-MF,RCI BMT 16 - NTCD,RCI BMT 17CD33,RCI BMT 17-CMS-MM,RCI BMT 17-CMSSCD,RCI BMT 17 - CSIDE,BMT CTN 1703 -
Allogeneic,Autologous
Page 3 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Has the recipient ever had a prior HCT?
No,Yes
Has the recipient ever had a prior
HCT?
Specify the number of prior HCTs:
Were all prior HCTs reported to the
CIBMTR?
open text
Specify the number of prior HCTs:
Were all prior HCTs reported to the
CIBMTR?
open text
No,Unknown,Yes
YYYY/MM/DD
Date of the prior HCT:
YYYY/MM/DD
No,Yes
No,Unknown,Yes
Prior Transplant
yes
yes
Date of the prior HCT:
Prior Transplant
yes
yes
yes
yes
Date estimated
checked
Was the prior HCT performed at a different
institution?
No,Yes
Date estimated
Was the prior HCT performed at a
different institution?
checked
Prior Transplant
Prior Transplant
yes
yes
Name:
open text
Name:
open text
Prior Transplant
yes
yes
City:
open text
City:
open text
Prior Transplant
yes
yes
State:
open text
State:
open text
Prior Transplant
yes
yes
Prior Transplant
yes
yes
Country:
What was the HPC source for the prior
HCT? (check all that apply)
open text
Allogeneic - related, Allogeneic unrelated, Autologous
Country:
What was the HPC source for the
prior HCT? (check all that apply)
open text
Allogeneic - related, Allogeneic -unrelated,
Autologous
Reason for current HCT
Graft failure / insufficient hematopoietic
recovery,Insufficient chimerism,New malignancy
(including PTLD and EBV
lymphoma),Other,Persistent primary
disease,Planned subsequent HCT, per
protocol,Recurrent primary disease
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Prior Cellular
Therapies
Prior Cellular
Therapies
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Prior Cellular
Therapies
Prior Cellular
Therapies
Prior Cellular
Therapies
Prior Cellular
Therapies
Prior Cellular
Therapies
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Prior Cellular
Therapies
No,Yes
no
no
Reason for current HCT
Graft failure / insufficient hematopoietic
recovery,Insufficient chimerism,New
malignancy (including PTLD and EBV
lymphoma),Other,Persistent primary
disease,Planned subsequent HCT, per
protocol,Recurrent primary disease
no
no
Date of graft failure / rejection:
YYYY/MM/DD
Date of graft failure / rejection:
YYYY/MM/DD
no
no
Date of relapse:
YYYY/MM/DD
Date of relapse:
YYYY/MM/DD
no
no
Date of secondary malignancy:
YYYY/MM/DD
Date of secondary malignancy:
YYYY/MM/DD
no
no
Specify other reason:
open text
open text
No,Unknown,Yes
Specify other reason:
Has the recipient ever had a prior
cellular therapy? (do not include
DLIs)
Were all prior cellular therapies
reported to the CIBMTR?
no
no
yes
no
Has the recipient ever had a prior cellular
therapy? (do not include DLIs)
Were all prior cellular therapies reported
to the CIBMTR?
yes
no
Date of the prior cellular therapy:
YYYY/MM/DD
Date of the prior cellular therapy:
YYYY/MM/DD
yes
no
Was the cellular therapy performed at a
different institution?
No,Yes
Was the cellular therapy performed
at a different institution?
No,Yes
yes
no
Name:
open text
Name:
open text
yes
no
City:
open text
City:
open text
yes
no
State:
open text
State:
open text
yes
no
Country:
open text
Country:
open text
yes
no
Specify the source(s) for the prior cellular
therapy (check all that apply)
Allogeneic-related,Allogeneicunrelated,Autologous
Specify the source(s) for the prior
Allogeneic-related,Allogeneiccellular therapy (check all that apply) unrelated,Autologous
no
no
Multiple donors?
no,yes
Multiple donors?
no,yes
no
no
Specify number of donors:
open text
Specify number of donors:
open text
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
No,Unknown,Yes
Rationale for Information Collection Update
No,Unknown,Yes
No,Unknown,Yes
Page 4 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
no
yes
no
yes
Allogeneic-related donor,AllogeneicSpecify donor
unrelated donor,Autologous
Bone marrow,Other product,PBSC,Single
Specify product type (check all that apply) cord blood unit
Specify donor
Specify product type (check all that
apply)
Allogeneic-related donor,Allogeneic-unrelated
donor,Autologous
Bone marrow,Other product,PBSC,Single cord
blood unit
no
yes
Specify other product:
open text
Specify other product:
open text
yes
yes
Is the product genetically modified?
Is the product genetically modified?
No,Yes
Allogeneic Donors yes
yes
Specify the related donor type
No,Yes
HLA-matched other relative,HLAmismatched relative,HLA-identical
sibling (may include non-monozygotic
twin),Syngeneic (monozygotic twin)
Fraternal
twin,Father,Grandchild,Grandparent,Mo
ther,Maternal aunt,Maternal
cousin,Maternal uncle,Other biological
relative,Paternal aunt,Paternal
cousin,Paternal uncle,Recipient's
child,Sibling
Specify the related donor type
HLA-matched other relative,HLA-mismatched
relative,HLA-identical sibling (may include nonmonozygotic twin),Syngeneic (monozygotic twin)
open text
1 HLA antigen mismatch, greater than or
equal to 2 HLA antigen mismatch (does
include haploidentical donor)
HLA matched unrelated,HLA
mismatched unrelated
Specify other biological relative:
NMDP cord blood unit ID:
Non-NMDP unrelated donor
ID:Registry donor ID:
open text
open text
open text
Fraternal
twin,Father,Grandchild,Grandparent,Mother,Mate
rnal aunt,Maternal cousin,Maternal uncle,Other
Specify the biological relationship of biological relative,Paternal aunt,Paternal
the donor to the recipient
cousin,Paternal uncle,Recipient's child,Sibling
Allogeneic Donors yes
yes
Specify the biological relationship of the
donor to the recipient
Allogeneic Donors yes
yes
Specify other biological relative:
Allogeneic Donors yes
yes
Degree of mismatch (related donors only)
Allogeneic Donors yes
yes
Allogeneic Donors yes
yes
Allogeneic Donors yes
yes
Allogeneic Donors yes
yes
Specify unrelated donor type
Did NMDP / Be the Match facilitate the
procurement, collection, or transportation
of the product?
No,Yes
Was this donor used for any prior HCTs?
(for this recipient)
no,yes
Global Registration Identifier for Donors
(GRID)
open text
Allogeneic Donors yes
yes
NMDP cord blood unit ID:
open text
Allogeneic Donors yes
yes
Non-NMDP unrelated donor ID:
open text
Allogeneic Donors yes
yes
Non-NMDP cord blood unit ID:
open text
Allogeneic Donors yes
yes
Is the CBU ID also the ISBT DIN number?
No,Unknown,Yes
Non-NMDP cord blood unit ID:
Is the CBU ID also the ISBT DIN
number?
Allogeneic Donors yes
yes
Specify the ISBT DIN number:
open text
Specify the ISBT DIN number:
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
open text
1 HLA antigen mismatch, greater than or equal to
Degree of mismatch (related donors 2 HLA antigen mismatch (does include
only)
haploidentical donor)
HLA matched unrelated,HLA mismatched
Specify unrelated donor type
unrelated
Did NMDP / Be the Match facilitate
the procurement, collection, or
transportation of the product?
No,Yes
Was this donor used for any prior
HCTs? (for this recipient)
no,yes
Global Registration Identifier for
Donors (GRID)
open text
Change/Clarification of Information Requested
open text
Capture data accurately
No,Unknown,Yes
Page 5 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element
Response
Option(s)
(A)
Austrian
Bone Marrow
Donors,(ACB) Austrian
Allogeneic Donors yes
yes
Registry or UCB Bank ID
Element
Response
Option(s)
(A)
Austrian
Bone Marrow
Donors,(ACB) Information Collection update:
Austrian Cord Blood Registry,(ACCB)
StemCyte, Inc,(AE) Emirates Bone
Marrow Donor Registry,(AM) Armenian
Bone Marrow Donor Registry Charitable
Trust,(AOCB) University of Colorado Cord
Blood Bank,(AR) Argentine CPH Donors
Registry,(ARCB) BANCEL - Argentina Cord
Blood Bank,(AUCB) Australian Cord
Blood Registry,(AUS) Australian / New
Zealand Bone Marrow Donor Registry,(B)
Marrow Donor Program Belgium,(BCB)
Belgium Cord Blood Registry,(BG)
Bulgarian Bone Marrow Donor
Registry,(BR) INCA/REDOMO,(BSCB)
British Bone Marrow Registry - Cord
Blood,(CB) Cord Blood Registry,(CH)
Swiss BloodStem Cells - Adult
Donors,(CHCB) Swiss Blood Stem Cells Cord Blood,(CKCB) Celgene Cord Blood
Bank,(CN) China Marrow Donor Program
(CMDP),(CNCB) Shan Dong Cord Blood
Bank,(CND) Canadian Blood Services
Bone Marrow Donor Registry,(CS2)
Czech National Marrow Donor
Registry,(CSCR) Czech Stem Cells
Registry,(CY) Cyprus Paraskevaidio Bone
Marrow Donor Registry,(CY2) The Cyprus
Bone Marrow Donor Registry,(D) ZKRD -
Registry or UCB Bank ID
Cord Blood Registry,(ACCB) StemCyte, Inc,(AE)
Emirates Bone Marrow Donor Registry,(AM)
Armenian Bone Marrow Donor Registry Charitable
Trust,(AOCB) University of Colorado Cord Blood
Bank,(AR) Argentine CPH Donors Registry,(ARCB)
BANCEL - Argentina Cord Blood Bank,(AUCB)
Australian Cord Blood Registry,(AUS) Australian /
New Zealand Bone Marrow Donor Registry,(B)
Marrow Donor Program Belgium,(BCB) Belgium
Cord Blood Registry,(BG) Bulgarian Bone Marrow
Donor Registry,(BR) INCA/REDOMO,(BSCB) British
Bone Marrow Registry - Cord Blood,(CB) Cord
Blood Registry,(CH) Swiss BloodStem Cells - Adult
Donors,(CHCB) Swiss Blood Stem Cells - Cord
Blood,(CKCB) Celgene Cord Blood Bank,(CN) China
Marrow Donor Program (CMDP),(CNCB) Shan
Dong Cord Blood Bank,(CND) Canadian Blood
Services Bone Marrow Donor Registry,(CS2) Czech
National Marrow Donor Registry,(CSCR) Czech
Stem Cells Registry,(CY) Cyprus Paraskevaidio Bone
Marrow Donor Registry,(CY2) The Cyprus Bone
Marrow Donor Registry,(D) ZKRD - Zentrales
Knochenmarkspender - Register Deutschland Adult
Donors,(DCB) ZKRD - Zentrales
Knochenmarkspender - Register Deutschland Cord
Blood,(DK) The Danish Bone Marrow Donor
Registry,(DK2) Bone Marrow Donors Copenhagen
(BMDC),(DUCB) German Branch of the European
Allogeneic Donors yes
yes
Specify other Registry or UCB Bank:
open text
Specify other Registry or UCB Bank:
open text
Allogeneic Donors yes
yes
Donor date of birth
Known,Unknown
Donor date of birth
Known,Unknown
Allogeneic Donors yes
yes
Donor date of birth:
YYYY/MM/DD
Donor date of birth:
YYYY/MM/DD
Allogeneic Donors yes
yes
yes
Donor age
Donor age: Months (use only if less
than 1 years old), Years
Known,Unknown
Allogeneic Donors yes
Donor age
Known,Unknown
Donor age: Months (use only if less than 1
years old), Years
open text
Allogeneic Donors yes
yes
Allogeneic Donors yes
yes
Allogeneic Donors yes
yes
Donor sex
Specify blood type (donor) (non-NMDP
allogeneic donors only)
Specify Rh factor (donor) (non-NMDP
allogeneic donors only)
Donor sex
female,male
Specify blood type (donor) (nonNMDP allogeneic donors only)
A,AB,B,O
Specify Rh factor (donor) (non-NMDP
allogeneic donors only)
Negative,Positive
Allogeneic Donors yes
yes
Donor CMV-antibodies (IgG or Total)
(Allogeneic HCTs only)
Allogeneic Donors yes
yes
Has the donor signed an IRB / ethics
committee (or similar body) approved
consent form to donate research blood
samples to the NMDP / CIBMTR? (Related
donors only)
Allogeneic Donors yes
yes
Allogeneic Donors yes
yes
Allogeneic Donors yes
Autologous
Transplant
yes
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
female,male
A,AB,B,O
Negative,Positive
Indeterminate, Not applicable (cord
blood unit), Non-reactive, Not done,
Reactive
No (donor declined), Not applicable
(center not participating), Not
approached, Yes (donor consented)
open text
Donor CMV-antibodies (IgG or Total) Indeterminate, Not applicable (cord blood unit),
(Allogeneic HCTs only)
Non-reactive, Not done, Reactive
Has the donor signed an IRB / ethics
committee (or similar body)
approved consent form to donate
No (donor declined), Not applicable (center not
research blood samples to the NMDP participating), Not approached, Yes (donor
/ CIBMTR? (Related donors only)
consented)
Date form was signed:
YYYY/MM/DD
Did the donor submit a research sample to
the NMDP/CIBMTR repository? (Related
donors only)
no,yes
Date form was signed:
Did the donor submit a research
sample to the NMDP/CIBMTR
repository? (related donors only)
YYYY/MM/DD
Research sample donor ID:
Specify number of products infused from
this donor:
Research sample donor ID:
Specify number of products infused
from this donor:
open text
open text
open text
Rationale for Information Collection Update
no,yes
open text
Page 6 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Autologous
Transplant
Autologous
Transplant
Autologous
Transplant
Autologous
Transplant
Autologous
Transplant
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
yes
yes
Specify the number of these products
intended to achieve hematopoietic
engraftment:
open text
yes
yes
What agents were used to mobilize the
autologous recipient for this HCT? (check
all that apply)
G-CSF (filgrastim, Neupogen), Pegylated
G-CSF (pegfilgrastim, Neulasta),
Plerixafor (Mozobil), Combined with
chemotherapy, Anti-CD20 (rituximab,
Rituxan), Other agent
Change/Clarification of Response Options
yes
yes
Specify other agent:
open text
yes
Name of product (gene therapy recipients) Other name
Specify other agent:
Name of product (gene therapy
recipients)
open text
yes
yes
yes
no
Specify other name:
What scale was used to determine
the recipient’s functional status?
open text
no
Specify other name:
What scale was used to determine the
recipient’s functional status?
no
Allogeneic
Recipient
Allogeneic
Recipient
no
no
no
yes
no
yes
no
no
no
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Karnofsky Scale (recipient age ≥ 16 years)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
open text
Karnofsky,Lansky
100 Normal; no complaints; no evidence
of disease,10 Moribund; fatal process
progressing rapidly,20 Very sick;
hospitalization necessary,30 Severely
disabled; hospitalization indicated,
although death not imminent,40
Disabled; requires special care and
assistance,50 Requires considerable
assistance and frequent medical care,60
Requires occasional assistance but is
able to care for most needs,70 Cares for
self; unable to carry on normal activity
or to do active work,80 Normal activity
with effort,90 Able to carry on normal
activity
100 Fully active,10 Completely disabled,
not even passive play,20 Limited to very
passive activity initiated by others (e.g.,
TV),30 Needs considerable assistance for
quiet activity,40 Able to initiate quiet
activities,50 Considerable assistance
required for any active play; fully able to
engage in quiet play,60 Ambulatory up
to 50% of time, limited active play with
assistance / supervision,70 Both greater
restrictions of, and less time spent in,
active play,80 Restricted in strenuous
play, tires more easily, otherwise
Lansky Scale (recipient age ≥ 1 year and < active,90 Minor restriction in physically
16 years)
strenuous play
Specify blood type (of recipient) (For
allogeneic HCTs only)
A,AB,B,O
Specify Rh factor (of recipient) (For
allogeneic HCTs only)
Negative,Positive
Indeterminate,Non-reactive,Not
Recipient CMV-antibodies (IgG or Total)
done,Reactive
Has the patient been infected with COVID19 (SARS-CoV-2) based on a positive test
result at any time prior to the start of the
preparative regimen / infusion?
No,Yes
Did the patient require hospitalization for
management of COVID-19 (SARS-CoV-2)
infection?
No,Yes
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
Specify the number of these products
intended to achieve hematopoietic
engraftment:
open text
G-CSF (TBO-filgrastim, filgrastim, Granix,
Neupogen) ,GM-CSF (sargramostim, Leukine),
Pegylated G-CSF (pegfilgrastim, Neulasta),
What agents were used to mobilize Plerixafor (Mozobil), Combined with
the autologous recipient for this
chemotherapy, Anti-CD20 (rituximab, Rituxan),
HCT? (check all that apply)
Other agent
Be consistent with current clinical landscape, improve
transplant outcome data
Karnofsky Scale (recipient age ≥ 16
years)
Lansky Scale (recipient age ≥ 1 year
and < 16 years)
Specify blood type (of recipient) (For
allogeneic HCTs only)
Specify Rh factor (of recipient) (For
allogeneic HCTs only)
Recipient CMV-antibodies (IgG or
Total)
Has the patient been infected with
COVID-19 (SARS-CoV-2) based on a
positive test result at any time prior
to the start of the preparative
regimen / infusion?
Did the patient require
hospitalization for management of
COVID-19 (SARS-CoV-2) infection?
Other name
Karnofsky,Lansky
100 Normal; no complaints; no evidence of
disease,10 Moribund; fatal process progressing
rapidly,20 Very sick; hospitalization necessary,30
Severely disabled; hospitalization indicated,
although death not imminent,40 Disabled;
requires special care and assistance,50 Requires
considerable assistance and frequent medical
care,60 Requires occasional assistance but is able
to care for most needs,70 Cares for self; unable to
carry on normal activity or to do active work,80
Normal activity with effort,90 Able to carry on
normal activity
100 Fully active,10 Completely disabled, not even
passive play,20 Limited to very passive activity
initiated by others (e.g., TV),30 Needs
considerable assistance for quiet activity,40 Able
to initiate quiet activities,50 Considerable
assistance required for any active play; fully able
to engage in quiet play,60 Ambulatory up to 50%
of time, limited active play with assistance /
supervision,70 Both greater restrictions of, and
less time spent in, active play,80 Restricted in
strenuous play, tires more easily, otherwise
active,90 Minor restriction in physically strenuous
play
A,AB,B,O
Negative,Positive
Indeterminate,Non-reactive,Not done,Reactive
No,Yes
No,Yes
Page 7 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
no
yes
COVID-19 Vaccine yes
yes
Was mechanical ventilation used for COVID19 (SARS-CoV-2) infection?
No,Yes
Change/Clarification of Information Requested
Was a vaccine for COVID-19 (SARS-CoV-2)
received?
No,Unknown,Yes
AstraZeneca,Johnson &
Johnson/Janssen,Moderna,Novavax,Oth
Specify vaccine brand
er (specify),Pfizer-BioNTech
COVID-19 Vaccine yes
yes
Specify other type:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Was mechanical ventilation used
given for COVID-19 (SARS-CoV-2)
infection?
Was a vaccine for COVID-19 (SARSCoV-2) received?
No,Yes
Specify vaccine brand
No,Unknown,Yes
AstraZeneca,Johnson &
Johnson/Janssen,Moderna,Novavax,Other
(specify),Pfizer-BioNTech
Specify other type:
open text
Select dose(s) received
Booster dose,First dose (with planned second
dose) ,One dose (without planned second dose)
,Second dose,Third dose
COVID-19 Vaccine yes
yes
Select dose(s) received
open text
Booster dose,First dose (with planned
second dose) ,One dose (without
planned second dose) ,Second
dose,Third dose
COVID-19 Vaccine yes
yes
Date received:
YYYY/MM/DD
Date received:
YYYY/MM/DD
COVID-19 Vaccine yes
yes
checked
no
no
no
no
no
Date estimated
Is there a history of mechanical
ventilation? (excluding COVID-19
(SARS-CoV-2))?
Is there a history of invasive fungal
infection?
Glomerular filtration rate (GFR)
before start of preparative regimen
(pediatric only)
checked
no
Date estimated
Is there a history of mechanical
ventilation? (excluding COVID-19 (SARSCoV-2))?
Is there a history of invasive fungal
infection?
Glomerular filtration rate (GFR) before
start of preparative regimen (pediatric
only)
no
no
no
no,yes
No,Yes
Known,Unknown
__ __ __ mL/min/1.732
no
Glomerular filtration rate (GFR):
no
Does the recipient have known complex
congenital heart disease? (corrected or
uncorrected) (excluding simple ASD, VSD,
or PDA repair) (pediatric only)
no
Were there any co-existing diseases or
organ impairment present according to the
HCT comorbidity index (HCT-CI)? (Source:
Sorror, M. L. (2013). How I assess
comorbidities before hematopoietic cell
transplantation. Blood, 121(15), 28542863.)
No,Yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
No,Yes
Rationale for Information Collection Update
Examples added or typographical errors corrected for clarification
no,yes
No,Yes
Known,Unknown
__ __ __ mL/min/1.732
Glomerular filtration rate (GFR):
Does the recipient have known
complex congenital heart disease?
(corrected or uncorrected) (excluding
simple ASD, VSD, or PDA repair)
(pediatric only)
No,Yes
Were there any co-existing diseases
or organ impairment present
according to the HCT comorbidity
index (HCT-CI)? (Source: Sorror, M. L.
(2013). How I assess comorbidities
before hematopoietic cell
transplantation. Blood, 121(15),
2854-2863.)
No,Yes
Page 8 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Pre-Transplant
Essential Data
Comorbid
Conditions
Yes
no
Specify co-existing diseases or organ
impairment (check all that apply)
Pre-Transplant
Essential Data
Comorbid
Conditions
Yes
no
Was the recipient on dialysis immediately
prior to start of preparative regimen?
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Comorbid
Conditions
Comorbid
Conditions
Comorbid
Conditions
Yes
no
Specify prior malignancy (check all that
apply)
Yes
no
Yes
no
Current Information Collection Data
Element Response
Option(s)
Information Collection update:
Arrhythmia
- Any history
of atrial
fibrillation or flutter, sick sinus
syndrome, or ventricular arrhythmias
requiring treatment
Cardiac -Any history of coronary artery
disease (one or more vessel-coronary
artery stenosis requiring medical
treatment, stent, or bypass graft),
congestive heart failure, myocardial
infarction, OR ejection fraction ≤ 50% on
the most recent test
Cerebrovascular disease -Any history of
transient ischemic attack, subarachnoid
hemorrhage or cerebral thrombosis,
embolism, or hemorrhage
Diabetes -Requiring treatment with
insulin or oral hypoglycemic drugs in the
last 4 weeks but not diet alone
Heart valve disease -At least a moderate
to severe degree of valve stenosis or
insufficiency as determined by Echo;
prosthetic mitral or aortic valve; or
symptomatic mitral valve prolapse
Hepatic, mild - Bilirubin > upper limit of
normal to 1.5 × upper limit of normal, or
AST/ALT > upper limit of normal to 2.5 ×
upper limit of normal at the time of
transplant OR any history of hepatitis B
or hepatitis C infection
No,Unknown,Yes
Breast cancer
Central nervous system (CNS)
malignancy (e.g., glioblastoma,
astrocytoma)
Gastrointestinal malignancy (e.g., colon,
rectum, stomach, pancreas, intestine,
esophageal)
Genitourinary malignancy (e.g., kidney,
bladder, ovary, testicle, genitalia, uterus,
cervix, prostate)
Leukemia
Lung cancer
Lymphoma (includes Hodgkin & nonHodgkin lymphoma)
MDS / MPN
Melanoma
Multiple myeloma / plasma cell disorder
(PCD)
Oropharyngeal cancer (e.g., tongue,
buccal mucosa)
Sarcoma
Thyroid cancer
Other skin malignancy (basal cell,
squamous cell)
Other hematologic malignancy
Change/Clarification of Response Options
Other solid tumor
Rationale for Information Collection Update
flutter, sick sinus syndrome, or ventricular
arrhythmias requiring treatment
Cardiac -Any history of coronary artery disease
(one or more vessel-coronary artery stenosis
requiring medical treatment, stent, or bypass
graft), congestive heart failure, myocardial
infarction, OR ejection fraction ≤ 50% on the most
recent test
Cerebrovascular disease -Any history of transient
ischemic attack, subarachnoid hemorrhage or
cerebral thrombosis, embolism, or hemorrhage
Diabetes -Requiring treatment with insulin or oral
hypoglycemic drugs in the last 4 weeks but not
diet alone
Heart valve disease -At least a moderate to severe
degree of valve stenosis or insufficiency as
determined by Echo; prosthetic mitral or aortic
valve; or symptomatic mitral valve prolapse
Hepatic, mild - Bilirubin > upper limit of normal to
1.5 × upper limit of normal, or AST/ALT > upper
limit of normal to 2.5 × upper limit of normal at
the time of transplant OR any history of hepatitis
B or hepatitis C infection
Hepatic, moderate/severe -Liver cirrhosis, bilirubin
> 1.5 × upper limit of normal, or AST/ALT > 2.5 ×
upper limit of normal
Specify co-existing diseases or organ Infection -Includes a documented infection, fever
impairment (check all that apply)
of unknown origin, or pulmonary nodules
Was the recipient on dialysis
immediately prior to start of
preparative regimen?
No,Unknown,Yes
Breast cancer
Central nervous system (CNS) malignancy (e.g.,
glioblastoma, astrocytoma)
Gastrointestinal malignancy (e.g., colon, rectum,
stomach, pancreas, intestine, esophageal)
Genitourinary malignancy (e.g., kidney, bladder,
ovary, testicle, genitalia, uterus, cervix, prostate)
Leukemia Acute myeloid leukemia
Chronic myeloid leukemia
Acute lymphoblastic leukemia
Chronic lymphoblastic leukemia
Lung cancer
Lymphoma (includes Hodgkin & non-Hodgkin
lymphoma)
MDS / MPN
Melanoma
Multiple myeloma / plasma cell disorder (PCD)
Oropharyngeal cancer (e.g., tongue, buccal
mucosa)
Sarcoma
Thyroid cancer
Other skin malignancy (basal cell, squamous cell)
Other hematologic malignancy
Other solid tumor
Specify prior malignancy (check all
Be consistent with current clinical landscape, improve
that apply)
transplant outcome data
open text
no
Specify other skin malignancy: (prior)
Specify other hematologic malignancy:
(prior)
open text
Specify other skin malignancy: (prior) open text
Specify other hematologic
malignancy: (prior)
open text
no
Specify other solid tumor: (prior)
open text
Specify other solid tumor: (prior)
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Deletion of Information Requested
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response
Option(s)
Arrhythmia
- Any history
of atrial fibrillation or
Reduce redundancy in data capture
open text
Page 9 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Prior Solid Organ
Transplant
Prior Solid Organ
Transplant
Prior Solid Organ
Transplant
Current Information Collection Data
Element Response Option(s)
Information Collection update:
no
no
no
Serum ferritin (within 4 weeks prior to the
___ ___ ___ ___ ___ ng/mL (μg/L)
start of the preparative regimen, use result
closest to the start date)
no
no
Date sample collected:
YYYY/MM/DD
no
Upper limit of normal for your institution:
open text
no
no
Serum albumin (within 4 weeks prior to
the start of the preparative regimen, use
result closest to the start date)
Known,Unknown
no
Serum albumin (within 4 weeks prior to
the start of the preparative regimen, use
result closest to the start date)
___ ___ ● __g/dL
___ ___ ● __ g/L
no
no
no
Date sample collected:
YYYY/MM/DD
no
no
Platelets (within 4 weeks prior to the start
of the preparative regimen, use result
closest to the start date)
Known,Unknown
no
Pre-Transplant
Essential Data
Current Information Collection Data
Element (if applicable)
Serum ferritin (within 4 weeks prior to the
start of the preparative regimen, use result
closest to the start date)
Known,Unknown
no
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
no
no
no
no
no
no
yes
yes
Specify organ
No,Yes
Bowel,Heart,Kidney(s),Liver,Lung,Other
organ,Pancreas
yes
yes
Specify other organ:
open text
yes
yes
no
no
Year of prior solid organ transplant:
YYYY
Height at initiation of pre-HCT preparative ___ ___ ___ inches
regimen:
___ ___ ___ cms
___ ___ ___ . ___pounds
___ ___ ___ . ___kilograms
no
no
Actual weight at initiation of pre-HCT
preparative regimen:
Pre-HCT Preparative
Regimen
no
no
Was a pre-HCT preparative regimen
prescribed?
Pre-HCT Preparative Allogeneic
Regimen
Recipient
yes
no
Classify the recipient’s prescribed
Myeloablative,Non-myeloablative
preparative regimen (Allogeneic HCTs only) (NST),Reduced intensity (RIC)
Pre-HCT Preparative
Regimen
no
no
no,yes
Pre-HCT Preparative
Regimen
no
no
Was irradiation planned as part of the preHCT preparative regimen?
no,yes
Total body by intensity-modulated
radiation therapy
(IMRT),Thoracoabdominal region,Total
What was the prescribed radiation field? body,Total lymphoid or nodal regions
Pre-HCT Preparative
Regimen
no
no
___ ___ ___ ___ . ___ Gy
Total prescribed dose: (dose per fraction x
___ ___ ___ ___ . ___ cGy
total number of fractions)
Rationale for Information Collection Update
Known,Unknown
___
___ ___ ___ ___ ng/mL (μg/L)
Date sample collected:
Upper limit of normal for your
institution:
Serum albumin (within 4 weeks prior
to the start of the preparative
regimen, use result closest to the
start date)
Serum albumin (within 4 weeks prior
to the start of the preparative
regimen, use result closest to the
start date)
YYYY/MM/DD
Date sample collected:
YYYY/MM/DD
open text
Known,Unknown
___ ___ ● __g/dL
___ ___ ● __ g/L
Platelets (within 4 weeks prior to the
start of the preparative regimen, use
result closest to the start date)
Known,Unknown
Platelets (within 4 weeks prior to the
start of the preparative regimen, use
result closest to the start date)
Were platelets transfused < 7 days
before date of test?
Did the recipient have a prior solid
organ transplant?
No,Unknown,Yes
Pre-HCT Preparative
Regimen
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Serum ferritin (within 4 weeks prior
to the start of the preparative
regimen, use result closest to the
start date)
Serum ferritin (within 4 weeks prior
to the start of the preparative
regimen, use result closest to the
start date)
___ ___ ___ ___ ___ ___ ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ x 106/L
Platelets (within 4 weeks prior to the start
of the preparative regimen, use result
closest to the start date)
Were platelets transfused < 7 days before
date of test?
Did the recipient have a prior solid organ
transplant?
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Change/Clarification of Response Options
___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ x 106/L
No,Unknown,Yes
Specify organ
No,Yes
Bowel,Heart,Kidney(s),Liver,Lung,Other
organ,Pancreas
Specify other organ:
open text
Year of prior solid organ transplant:
Height at initiation of pre-HCT
preparative regimen:
YYYY
___ ___ ___ inches
___ ___ ___ cms
Capture data accurately
___ ___ ___ . ___pounds
Actual weight at initiation of pre-HCT
___ ___ ___ . ___kilograms
preparative regimen:
Was a pre-HCT preparative regimen
prescribed?
no,yes
Classify the recipient’s prescribed
preparative regimen (Allogeneic HCTs Myeloablative,Non-myeloablative (NST),Reduced
only)
intensity (RIC)
Was irradiation planned as part of
the pre-HCT preparative regimen?
no,yes
What was the prescribed radiation
field?
Total body by intensity-modulated radiation
therapy (IMRT),Thoracoabdominal region,Total
body,Total lymphoid or nodal regions
Total prescribed dose: (dose per
fraction x total number of fractions)
___ ___ ___ ___ . ___ Gy
___ ___ ___ ___ . ___ cGy
Page 10 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Pre-HCT Preparative
Regimen
no
no
Date started:
YYYY/MM/DD
Date started:
YYYY/MM/DD
Pre-HCT Preparative
Regimen
no
no
Was the radiation fractionated?
no,yes
Was the radiation fractionated?
no,yes
Pre-HCT Preparative
Regimen
no
no
Total number of fractions:
Total number of fractions:
Pre-HCT Preparative
Regimen
no
no
Drug (drop down list)
open text
Bendamustine,Busulfan,Carboplatin,Car
mustine,Clofarabine,Cyclophosphamide,
Cytarabine,Etoposide,Fludarabine,Gemci
tabine,Ibritumomab
tiuxetan,Ifosfamide,Lomustine,Melphala
n,Methylprednisolone,Other,Pentostatin
,Propylene glycol-free
melphalan,Rituximab,Thiotepa,Tositumo
mab,Treosulfan
Change/Clarification of Response Options
open text
Bendamustine,Busulfan,Carboplatin,Carmustine,Cl
ofarabine,Cyclophosphamide,Cytarabine,Etoposid
e,Fludarabine,Gemcitabine,Ibritumomab
tiuxetan,Ifosfamide,Lomustine,Melphalan,Methyl
prednisolone,Other,Pentostatin,Propylene glycolfree
melphalan,Rituximab,Thiotepa,Tositumomab,Treo
sulfan, Azathioprine, Bortezomib, Cisplatin,
Be consistent with current clinical landscape, improve
Hydroxyurea, and Vincristine.
transplant outcome data
Pre-HCT Preparative
Regimen
no
yes
Specify other drug:
Specify other drug:
Pre-HCT Preparative
Regimen
no
yes
Total prescribed dose:
open text
__ __ __ __ __. __ mg/m2
__ __ __ __ __. __mg/kg
__ __ __ __ __. __AUC (mg x h/L)
__ __ __ __ __. __AUC (µmol x min/L)
__ __ __ __ __. __CSS (ng/mL)
Total prescribed dose:
open text
__ __ __ __ __. __ mg/m2
__ __ __ __ __. __mg/kg
__ __ __ __ __. __AUC (mg x h/L)
__ __ __ __ __. __AUC (µmol x min/L)
__ __ __ __ __. __CSS (ng/mL)
Pre-HCT Preparative
Regimen
no
yes
Date started:
YYYY/MM/DD
Date started:
YYYY/MM/DD
no
yes
Specify administration (busulfan only)
Both,IV,Oral
Specify administration (busulfan
only)
Both,IV,Oral
Pre-HCT Preparative
Regimen
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
GVHD Prophylaxis
no,yes
Change/Clarification of Information Requested and
Response Option
Drug (drop down list)
ALG, ALS, ATG, ATS, Alemtuzumab,
Defibrotide, KGF, Ursodiol
no
no
ALG, ALS, ATG, ATS
no
no
Total prescribed dose:
no
no
Specify source
ATGAM (horse),ATG - Fresenius
(rabbit),Other,Thymoglobulin (rabbit)
Specify source
ATGAM (horse),ATG - Fresenius
(rabbit),Other,Thymoglobulin (rabbit)
no
no
Specify other source:
open text
Specify other source:
open text
no
no
Alemtuzumab (Campath)
Deletion of Information: Merged to Check all that Apply
Alemtuzumab (Campath)
no
no
Total prescribed dose:
no,yes
__ __ __ __ . _ mg/m2
__ __ __ __ __ . __mg/kg
__ __ __ __ __ . __mg/kg
Total prescribed dose:
no,yes
__ __ __ __ . _ mg/m2
__ __ __ __ __ . __mg/kg
__ __ __ __ __ . __mg/kg
no
no
Defibrotide
No,Yes
Deletion of Information: Merged to Check all that Apply
Defibrotide
No,Yes
no
no
KGF
No,Yes
Deletion of Information: Merged to Check all that Apply
KGF
No,Yes
no
no
Ursodiol
No,Yes
Deletion of Information: Merged to Check all that Apply
Ursodiol
No,Yes
yes
no
Was GVHD prophylaxis planned?
No,Yes
Was GVHD prophylaxis planned?
No,Yes
__ __ __ __ __ mg/kg
Allogeneic
Recipient
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
no,yes (check all that apply)
Rationale for Information Collection Update
Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"
__ __ __ __ __ mg/kg
Total prescribed dose:
Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"
Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"
Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"
Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"
Page 11 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
GVHD Prophylaxis
GVHD Prophylaxis
Post-HCT Disease
Therapy Planned as
of Day 0
Post-HCT Disease
Therapy Planned as
of Day 0
Post-HCT Disease
Therapy Planned as
of Day 0
Allogeneic
Recipient
Allogeneic
Recipient
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
yes
no
Abatacept,Anti CD 25(Zenapax,
Daclizumab, AntiTAC),Blinded
randomized trial,Bortezomib,CD34
enriched(CD34+
selection),Corticosteriods
(systemic),Cyclophosphamide
(Cytoxan),Cyclosporine (CSA, Neoral,
Sandimmune),Extra-corporeal
photopheresis (ECP),Ex-vivo T-cell
depletion,Filgotinib,Maraviroc,Mycophe
nolate mofetil (MMF)
(Cellcept),Methotrexate (MTX)
(Amethopterin),Other
agent,Ruxolitinib,Sirolimus (Rapamycin,
Specify drugs / intervention (check all that Rapamune),Tacrolimus(FK
apply)
506),Tocilizumab
Abatacept,Anti CD 25(Zenapax, Daclizumab,
AntiTAC),Blinded randomized
trial,Bortezomib,CD34 enriched(CD34+
selection),Corticosteriods
(systemic),Cyclophosphamide
(Cytoxan),Cyclosporine (CSA, Neoral,
Sandimmune),Extra-corporeal photopheresis
(ECP),Ex-vivo T-cell
depletion,Filgotinib,Maraviroc,Mycophenolate
mofetil (MMF) (Cellcept),Methotrexate (MTX)
(Amethopterin),Other agent,Ruxolitinib,Sirolimus
Specify drugs / intervention (check all (Rapamycin, Rapamune),Tacrolimus(FK
that apply)
506),Tocilizumab
yes
no
Specify other agent:
open text (do not report ATG, campath)
Specify other agent:
open text (do not report ATG, campath)
no
no
Is additional post-HCT therapy planned?
no,yes
Is additional post-HCT therapy
planned?
no,yes
Azacitidine(Vidaza),Blinatumomab,Borte
zomib
(Velcade),Bosutinib,Brentuximab,Carfilz
omib,Cellular therapy (e.g. DCI,
DLI),Crenolanib,Daratumumab,Dasatinib
,Decitabine,Elotuzumab,Enasidenib,Gilte
ritinib,Ibrutinib,Imanitib mesylate
(Gleevec, Glivec),Intrathecal
chemotherapy,Ivosidenib,Ixazomib,Lenal
idomide (Revlimid),Lestaurtinib,Local
radiotherapy,Midostaurin,Nilotinib,Obin
utuzumab,Other,Pacritinib,Ponatinib,Qu
izartinib,Rituximab (Rituxan,
Mabthera),Sorafenib,Sunitinib,Thalidomi
de (Thalomid),Unknown
Specify post-HCT therapy planned
Azacitidine(Vidaza),Blinatumomab,Bortezomib
(Velcade),Bosutinib,Brentuximab,Carfilzomib,Cellu
lar therapy (e.g. DCI,
DLI),Crenolanib,Daratumumab,Dasatinib,Decitabin
e,Elotuzumab,Enasidenib,Gilteritinib,Ibrutinib,Ima
nitib mesylate (Gleevec, Glivec),Intrathecal
chemotherapy,Ivosidenib,Ixazomib,Lenalidomide
(Revlimid),Lestaurtinib,Local
radiotherapy,Midostaurin,Nilotinib,Obinutuzumab
,Other,Pacritinib,Ponatinib,Quizartinib,Rituximab
(Rituxan,
Mabthera),Sorafenib,Sunitinib,Thalidomide
(Thalomid),Unknown
Specify other therapy:
open text
Blinatumomab(Blincyto),Gemtuzumab ozogamicin
(Mylotarg),Inotuzumab ozogamicin (Besponsa)
,Mogamulizumab (Poteligeo) ,None,Thiotepa
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
no
no
Specify post-HCT therapy planned
no
no
Specify other therapy:
Prior Exposure:
Potential Study
Eligibility
no
no
Covid-19 Impact
no
no
Addition of Information Requested
Covid-19 Impact
no
no
Addition of Information Requested
Specify if the recipient received any
of the following (at any time prior to
HCT / infusion) (check all that apply)
Was the HCT impacted for a reason
related to the COVID-19 (SARS-CoV2) pandemic?
Is the HCT date different than the
originally intended HCT date?
Covid-19 Impact
no
no
Addition of Information Requested
Original Date of HCT
Covid-19 Impact
no
no
Addition of Information Requested
Covid-19 Impact
no
no
Addition of Information Requested
Date estimated
Is the donor different than the
originally intended donor?
Covid-19 Impact
no
no
Addition of Information Requested
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
open text
Blinatumomab(Blincyto),Gemtuzumab
ozogamicin (Mylotarg),Inotuzumab
Specify if the recipient received any of the ozogamicin (Besponsa)
following (at any time prior to HCT /
,Mogamulizumab (Poteligeo)
infusion) (check all that apply)
,None,Thiotepa
Rationale for Information Collection Update
no,yes
Covid-19 Impact
no,yes
Covid-19 Impact
YYYY/MM/DD
Covid-19 Impact
checked
Covid-19 Impact
no,yes
Covid-19 Impact
unrelated donor, syngeneic (monozygotic twin) ,
HLA-idential sibling (may include non-monozygotic
twin) , HLA-matched other relative (does NOT
include a haplo-identical donor), HLA-mismatched
Specify the originally intended donor relative
Covid-19 Impact
Page 12 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Covid-19 Impact
no
no
Addition of Information Requested
Covid-19 Impact
no
no
Addition of Information Requested
Covid-19 Impact
no
no
Addition of Information Requested
Covid-19 Impact
no
no
Addition of Information Requested
Covid-19 Impact
no
no
Addition of Information Requested
Covid-19 Impact
Disease
Classification
no
no
Disease
Classification
no
no
yes
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Addition of Information Requested
Date of diagnosis of primary disease for
HCT / cellular therapy:
YYYY/MM/DDdiseases,Acute
Autoimmune
lymphoblastic leukemia (ALL),Acute
myelogenous leukemia (AML or
ANLL),Chronic myelogenous leukemia
(CML),Hemoglobinopathies,Histiocytic
disorders,Hodgkin lymphoma,Inherited
Bone Marrow Failure Syndromes(If the
recipient developed MDS or AML,
indicate MDS or AML as the primary
disease.)– ,Disorders of the immune
system,Inherited disorders of
metabolism,Inherited abnormalities of
platelets,Myelodysplastic syndrome
(MDS) (If recipient has transformed to
AML, indicate AML as the primary
disease.),Myeloproliferative neoplasms
(MPN)(If recipient has transformed to
AML, indicate AML as the primary
disease.),Non-Hodgkin lymphoma,Acute
leukemia of ambiguous lineage and
other myeloid neoplasms,Other
disease,Other leukemia (includes
CLL),Multiple myeloma / plasma cell
disorder (PCD),Paroxysmal nocturnal
hemoglobinuria (PNH),Recessive
dystrophic epidermolysis
bullosa,Aplastic Anemia(If the recipient
What was the primary disease for which
developed MDS or AML, indicate MDS or
the HCT / cellular therapy was performed? AML as the primary disease.) ,Solid
Change/Clarification of Response Options
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
Is the product type (bone marrow,
PBSC, cord blood unit) different than
the originally intended product type? no,yes
Covid-19 Impact
Specify the originally intended
product type
bone marrow,Other product,PBSC, cord blood unit Covid-19 Impact
Specify other product type
Was the current product thawed
from a cryopreserved state prior to
infusion?
Did the preparative regimen change
from the original plan?
Did the GVHD prophylaxis change
from the original plan?
Date of diagnosis of primary disease
for HCT / cellular therapy:
open text
Covid-19 Impact
no,yes
Covid-19 Impact
no, yes
Covid-19 Impact
no,yes
Covid-19 Impact
YYYY/MM/DD
Autoimmune diseases,Acute lymphoblastic
leukemia (ALL),Acute myelogenous myeloid
leukemia (AML or ANLL),Chronic myelogenous
leukemia (CML),Hemoglobinopathies,Histiocytic
disorders,Hodgkin lymphoma,Inherited Bone
Marrow Failure Syndromes(If the recipient
developed MDS or AML, indicate MDS or AML as
the primary disease.)– ,Disorders of the immune
system,Inherited disorders of
metabolism,Inherited abnormalities of
platelets,Myelodysplastic syndrome (MDS) (If
recipient has transformed to AML, indicate AML as
the primary disease.),Myeloproliferative
neoplasms (MPN)(If recipient has transformed to
AML, indicate AML as the primary disease.),NonHodgkin lymphoma,Acute leukemia of ambiguous
lineage and other myeloid neoplasms,Other
disease,Other leukemia (includes CLL),Multiple
myeloma / plasma cell disorder (PCD),Paroxysmal
nocturnal hemoglobinuria (PNH),Recessive
dystrophic epidermolysis bullosa,Aplastic
Anemia(If the recipient developed MDS or AML,
What was the primary disease for
indicate MDS or AML as the primary disease.)
which the HCT / cellular therapy was ,Solid tumors,Tolerance induction associated with
performed?
solid organ transplant
Capture data accurately
Page 13 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
yes
no
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Specify the AML classification
Specify the AML classification
AML with t(9;11) (p22.3;q23.3); MLLT3-KMT2A (5),
AML with t(6;9) (p23;q34.1); DEK-NUP214 (6),
AML with inv(3) (q21.3;q26.2) or t(3;3)
(q21.3;q26.2); GATA2, MECOM (7),
AML (megakaryoblastic) with t(1;22)
(p13.3;q13.3); RBM15-MKL1 (8),
AML with t(8;21); (q22; q22.1); RUNX1-RUNX1T1
(281),
AML with inv(16) (p13.1;1q22) or t(16;16)(p13.1;
q22); CBFB-MYH11 (282),
APL with PML-RARA (283),
AML with BCR-ABL1 (provisional entity) (3),
AML with mutated NPM1 (4),
AML with biallelic mutations of CEBPA (297),
AML with mutated RUNX1 (provisional entity)
(298),
AML with 11q23 (MLL) abnormalities (i.e., t(4;11),
t(6;11), t(9;11), t(11;19)) (284),
AML with myelodysplasia – related changes (285),
Therapy related AML (t-AML) (9),
AML, not otherwise specified:
AML, not otherwise specified (280),
AML, minimally differentiated (286),
AML without maturation (287) ,
AML with maturation (288) ,
Acute myelomonocytic leukemia (289),
Acute monoblastic / acute monocytic leukemia
(290),
Did AML transform from MDS or
MPN?
no,yes-Also complete MDS or MPN Disease
Classification questions
Is the disease (AML) therapy related? no,Unknown,yes
yes
no
Did AML transform from MDS or MPN?
no,yes-Also complete MDS or MPN
Disease Classification questions
yes
no
Is the disease (AML) therapy related?
no,Unknown,yes
yes
no
Did the recipient have a predisposing
condition?
yes
no
Specify condition
no,Unknown,yes
Bloom syndrome,Dyskeratosis
congenita,Down Syndrome,Fanconi
anemia,Other condition
yes
no
Specify other condition:
open text
yes
yes
Were cytogenetics tested (karyotyping or
FISH)? (at diagnosis)
no,Unknown,yes
yes
yes
Were cytogenetics tested via FISH?
No,Yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
Specify number of distinct cytogenetic
abnormalities
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element
Option(s)
AML
withResponse
recurrent genetic
abnormalities:
Element
Option(s)
Information Collection update:
AML
withResponse
recurrent genetic
abnormalities:
AML with t(9;11) (p22.3;q23.3); MLLT3KMT2A (5),
AML with t(6;9) (p23;q34.1); DEKNUP214 (6),
AML with inv(3) (q21.3;q26.2) or t(3;3)
(q21.3;q26.2); GATA2, MECOM (7),
AML (megakaryoblastic) with t(1;22)
(p13.3;q13.3); RBM15-MKL1 (8),
AML with t(8;21); (q22; q22.1); RUNX1RUNX1T1 (281),
AML with inv(16) (p13.1;1q22) or
t(16;16)(p13.1; q22); CBFB-MYH11 (282),
APL with PML-RARA (283),
AML with BCR-ABL1 (provisional entity)
(3),
AML with mutated NPM1 (4),
AML with biallelic mutations of CEBPA
(297),
AML with mutated RUNX1 (provisional
entity) (298),
AML with 11q23 (MLL) abnormalities
(i.e., t(4;11), t(6;11), t(9;11), t(11;19))
(284),
AML with myelodysplasia – related
changes (285),
Therapy related AML (t-AML) (9),
AML, not otherwise specified:
Did the recipient have a predisposing
condition?
no,Unknown,yes
Specify condition
Bloom syndrome,Dyskeratosis congenita,Down
Syndrome,Fanconi anemia,Other condition
Specify other condition:
Were cytogenetics tested
(karyotyping or FISH)? (at diagnosis
or relapse)
open text
Were cytogenetics tested via FISH?
No,Yes
Abnormalities identified,No abnormalities
open text
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Four or more (4 or more),One (1),Three
(3),Two (2)
Specify number of distinct
cytogenetic abnormalities
Abnormalities identified,No
abnormalities
Rationale for Information Collection Update
Change/Clarification of Information Requested
no,Unknown,yes
Reduce redundancy in data capture
open text
Four or more (4 or more),One (1),Three (3),Two (2)
Page 14 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
yes
yes
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8
yes
yes
Specify other abnormality:
yes
yes
Were cytogenetics tested via karyotyping? No,Yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
yes
Specify number of distinct cytogenetic
abnormalities
open text
Abnormalities identified,No
abnormalities,No evaluable metaphases
yes
yes
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
yes
yes
Were tests for molecular markers
performed? (at diagnosis)
no,Unknown,yes
yes
yes
CEBPA
Negative,Not Done,Positive
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8
Specify other abnormality:
open text
Were cytogenetics tested via
karyotyping?
No,Yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Specify number of distinct
cytogenetic abnormalities
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
Four or more (4 or more),One (1),Three (3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8
Change/Clarification of Information Requested
open text
No,Yes
Were tests for molecular markers
performed? (at diagnosis or relapse) no,Unknown,yes
CEBPA
Negative,Not Done,Positive
Specify CEBPA mutation
Biallelic (double mutant),Monoallelic (single
mutant),Unknown
yes
yes
Specify CEBPA mutation
Biallelic (homozygous),Monoallelic
(heterozygous),Unknown
yes
yes
FLT3 - TKD (point mutations in D835 or
deletions of codon I836)
Negative,Not done,Positive
FLT3 - TKD (point mutations in D835
or deletions of codon I836)
Negative,Not done,Positive
yes
yes
FLT3 – ITD mutation
Negative,Not Done,Positive
FLT3 – ITD mutation
Negative,Not Done,Positive
yes
yes
FLT3 - ITD allelic ratio
Known,Unknown
FLT3 - ITD allelic ratio
Known,Unknown
Change/Clarification of Response Options
__ __ . __ __
yes
yes
Specify FLT3 - ITD allelic ratio:
yes
yes
IDH1
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
Reduce redundancy in data capture
Capture data accurately
__ __ . __ __
Specify FLT3 - ITD allelic ratio:
Negative,Not Done,Positive
IDH1
Negative,Not Done,Positive
Page 15 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
yes
yes
IDH2
Negative,Not Done,Positive
IDH2
Negative,Not Done,Positive
yes
yes
KIT
Negative,Not Done,Positive
KIT
Negative,Not Done,Positive
yes
yes
NPM1
Negative,Not Done,Positive
NPM1
Negative,Not Done,Positive
yes
yes
Other molecular marker
Negative,Not Done,Positive
Other molecular marker
Negative,Not Done,Positive
yes
yes
Specify other molecular marker:
open text
open text
yes
yes
Were cytogenetics tested (karyotyping or
FISH)? (between diagnosis and last
evaluation)
no,Unknown,yes
Specify other molecular marker:
Were cytogenetics tested
(karyotyping or FISH)? (between
diagnosis or relapse and last
evaluation)
yes
yes
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Abnormalities identified,No abnormalities
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
yes
Specify number of distinct cytogenetic
abnormalities
Abnormalities identified,No
abnormalities
open text
yes
yes
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8
yes
yes
Specify other abnormality:
yes
yes
Were cytogenetics tested via karyotyping? No,Yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
Specify number of distinct cytogenetic
abnormalities
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
open text
Abnormalities identified,No
abnormalities,No evaluable metaphases
Change/Clarification of Information Requested
no,Unknown,yes
Rationale for Information Collection Update
Reduce redundancy in data capture
open text
Specify number of distinct
cytogenetic abnormalities
Specify other abnormality:
open text
Were cytogenetics tested via
karyotyping?
No,Yes
Four or more (4 or more),One (1),Three (3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8
open text
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Four or more (4 or more),One (1),Three
(3),Two (2)
Specify number of distinct
cytogenetic abnormalities
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
Four or more (4 or more),One (1),Three (3),Two (2)
Page 16 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
yes
yes
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
yes
yes
Were tests for molecular markers
performed? (e.g. PCR, NGS) (between
diagnosis and last evaluation)
no,Unknown,yes
yes
yes
CEBPA
Negative,Not Done,Positive
yes
yes
Specify CEBPA mutation
Biallelic (homozygous),Monoallelic
(heterozygous),Unknown
yes
yes
FLT3 - TKD (point mutations in D835 or
deletions of codon I836)
Negative,Not done,Positive
FLT3 - TKD (point mutations in D835
or deletions of codon I836)
Negative,Not done,Positive
yes
yes
FLT3 – ITD mutation
Negative,Not Done,Positive
FLT3 – ITD mutation
Negative,Not Done,Positive
yes
yes
FLT3 - ITD allelic ratio
Known,Unknown
FLT3 - ITD allelic ratio
Known,Unknown
yes
yes
Specify FLT3 - ITD allelic ratio:
yes
yes
IDH1
Negative,Not Done,Positive
IDH1
Negative,Not Done,Positive
yes
yes
IDH2
Negative,Not Done,Positive
IDH2
Negative,Not Done,Positive
yes
yes
KIT
Negative,Not Done,Positive
KIT
Negative,Not Done,Positive
yes
yes
NPM1
Negative,Not Done,Positive
NPM1
Negative,Not Done,Positive
yes
yes
Other molecular marker
Negative,Not Done,Positive
Other molecular marker
Negative,Not Done,Positive
yes
yes
Specify other molecular marker:
open text
open text
yes
yes
Were cytogenetics tested (karyotyping or
FISH)? (at last evaluation)
no,Unknown,yes
Specify other molecular marker:
Were cytogenetics tested
(karyotyping or FISH)? (at last
evaluation)
yes
yes
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8
Change/Clarification of Information Requested
Change/Clarification of Response Options
Specify other abnormality:
open text
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
No,Yes
Were tests for molecular markers
performed? (e.g. PCR, NGS) (between
diagnosis or relapse and last
evaluation)
no,Unknown,yes
CEBPA
Negative,Not Done,Positive
Specify CEBPA mutation
Biallelic (double mutant),Monoallelic (single
mutant),Unknown
__ __ . __ __
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
Reduce redundancy in data capture
Capture data accurately
__ __ . __ __
Specify FLT3 - ITD allelic ratio:
no,Unknown,yes
Page 17 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
yes
Specify number of distinct cytogenetic
abnormalities
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Abnormalities identified,No
abnormalities
yes
yes
yes
yes
Specify other abnormality:
yes
yes
Were cytogenetics tested via karyotyping? No,Yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
Specify number of distinct cytogenetic
abnormalities
Abnormalities identified,No
abnormalities,No evaluable metaphases
yes
yes
yes
Specify other abnormality:
Abnormalities identified,No abnormalities
open text
Specify number of distinct
cytogenetic abnormalities
Specify other abnormality:
open text
Were cytogenetics tested via
karyotyping?
No,Yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
yes
Four or more (4 or more),One (1),Three (3),Two (2)
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
Specify number of distinct
cytogenetic abnormalities
open text
no,Unknown,yes
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Were tests for molecular markers
performed?(e.g. PCR, NGS) (at last
evaluation)
CEBPA
Negative,Not Done,Positive
Specify CEBPA mutation
Biallelic (double mutant),Monoallelic (single
mutant),Unknown
Four or more (4 or more),One (1),Three (3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8
open text
yes
yes
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
Were tests for molecular markers
performed?(e.g. PCR, NGS) (at last
evaluation)
yes
yes
CEBPA
Negative,Not Done,Positive
yes
yes
Specify CEBPA mutation
Biallelic (homozygous),Monoallelic
(heterozygous),Unknown
yes
yes
FLT3 - TKD (point mutations in D835 or
deletions of codon I836)
Negative,Not done,Positive
FLT3 - TKD (point mutations in D835
or deletions of codon I836)
Negative,Not done,Positive
yes
yes
FLT3 – ITD mutation
Negative,Not Done,Positive
FLT3 – ITD mutation
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
No,Yes
Change/Clarification of Response Options
No,Yes
no,Unknown,yes
Capture data accurately
Negative,Not Done,Positive
Page 18 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
yes
yes
FLT3 - ITD allelic ratio
Known,Unknown
FLT3 - ITD allelic ratio
Known,Unknown
yes
yes
Specify FLT3 - ITD allelic ratio:
__ __ . __ __
Specify FLT3 - ITD allelic ratio:
__ __ . __ __
yes
yes
IDH1
Negative,Not Done,Positive
IDH1
Negative,Not Done,Positive
yes
yes
IDH2
Negative,Not Done,Positive
IDH2
Negative,Not Done,Positive
yes
yes
KIT
Negative,Not Done,Positive
KIT
Negative,Not Done,Positive
yes
yes
NPM1
Negative,Not Done,Positive
NPM1
Negative,Not Done,Positive
yes
yes
Other molecular marker
Negative,Not Done,Positive
Other molecular marker
Negative,Not Done,Positive
yes
yes
Specify other molecular marker:
open text
no
Did the recipient have central nervous
system leukemia at any time prior to the
start of the preparative regimen / infusion? no,Unknown,yes
Specify other molecular marker:
open text
Did the recipient have central
nervous system leukemia at any time
prior to the start of the preparative
regimen / infusion?
no,Unknown,yes
yes
1st complete remission,1st relapse,2nd
complete remission,2nd relapse,≥ 3rd
complete remission, ≥3rd relapse,No
treatment,Primary induction failure
What was the disease status?
How many cycles of induction
therapy were required to achieve 1st
complete remission? (includes CRi) 1,2, ≥ 3
Rationale for Information Collection Update
1st complete remission,1st relapse,2nd complete
remission,2nd relapse,≥ 3rd complete remission,
≥3rd relapse,No treatment,Primary induction
failure
no
What was the disease status?
no
How many cycles of induction therapy
were required to achieve 1st complete
remission? (includes CRi)
1,2, ≥ 3
yes
no
Was the recipient in remission by flow
cytometry?
Not applicable,No,Unknown,Yes
yes
no
Addition of Information Requested
Was the recipient in remission by
flow cytometry?
Specify method(s) that was used to
assess measurable residual disease
status (check all that apply)
yes
no
Addition of Information Requested
Was measurable residual disease
detected by FISH?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Addition of Information Requested
Was measurable residual disease
detected by karyotyping assay?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Addition of Information Requested
yes
no
yes
yes
yes
yes
Deletion of Information Requested
Not applicable,No,Unknown,Yes
Reduce redundancy in data capture
FISH, Karyotyping, Flow Cytometry, PCR, NGS, Not Be consistent with current clinical landscape, improve
assessed
transplant outcome data
Be consistent with current clinical landscape, improve
transplant outcome data
Addition of Information Requested
Which leukemia phenotype was used original leukemia immunophenotype, aberrant
for detection (check all the apply)
phenotype
What is the lower limit of detection
(for the original leukemia
immunophenotype)
open text
no
Addition of Information Requested
What is the lower limit of detection
(for the aberrant phenotype)
open text
Be consistent with current clinical landscape, improve
transplant outcome data
no
Addition of Information Requested
Was measurable residual disease
detected by flow cytometry?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Be consistent with current clinical landscape, improve
transplant outcome data
Page 19 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
yes
no
Addition of Information Requested
Was measurable residual disease
detected by PCR?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Addition of Information Requested
Was measurable residual disease
detected by NGS?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Date of most recent relapse:
YYYY/MM/DD
Date of most recent relapse:
YYYY/MM/DD
yes
no
Date assessed:
Date assessed:
yes
no
Specify ALL classification
YYYY/MM/DD
B-lymphoblastic leukemia / lymphoma:
B-lymphoblastic leukemia / lymphoma,
NOS (B-cell ALL, NOS) (191),
B-lymphoblastic leukemia / lymphoma
with t(9;22)(q34.1;q11.2); BCR-ABL1
(192),
B-lymphoblastic leukemia / lymphoma
with t(v;11q23.3); KMT2A rearranged
(193),
B-lymphoblastic leukemia / lymphoma
with t(1;19)(q23;p13.3); TCF3-PBX1
(194),
B-lymphoblastic leukemia / lymphoma
with t(12;21) (p13.2;q22.1); ETV6RUNX1 (195),
B-lymphoblastic leukemia / lymphoma
with t(5;14) (q31.1;q32.3); IL3-IGH (81),
B-lymphoblastic leukemia / lymphoma
with Hyperdiploidy (51-65
chromosomes) (82),
B-lymphoblastic leukemia / lymphoma
with Hypodiploidy (<46 chromosomes)
(83),
B-lymphoblastic leukemia / lymphoma,
BCR-ABL1-like (provisional entity) (94),
B-lymphoblastic leukemia / lymphoma,
with iAMP21 (95),
T-cell lymphoblastic leukemia /
lymphoma:
YYYY/MM/DD
B-lymphoblastic leukemia / lymphoma:
B-lymphoblastic leukemia / lymphoma, NOS (B-cell
ALL, NOS) (191),
B-lymphoblastic leukemia / lymphoma with
t(9;22)(q34.1;q11.2); BCR-ABL1 (192),
B-lymphoblastic leukemia / lymphoma with
t(v;11q23.3); KMT2A rearranged (193),
B-lymphoblastic leukemia / lymphoma with
t(1;19)(q23;p13.3); TCF3-PBX1 (194),
B-lymphoblastic leukemia / lymphoma with
t(12;21) (p13.2;q22.1); ETV6-RUNX1 (195),
B-lymphoblastic leukemia / lymphoma with
t(5;14) (q31.1;q32.3); IL3-IGH (81),
B-lymphoblastic leukemia / lymphoma with
Hyperdiploidy (51-65 chromosomes) (82),
B-lymphoblastic leukemia / lymphoma with
Hypodiploidy (<46 chromosomes) (83),
B-lymphoblastic leukemia / lymphoma, BCR-ABL1like (provisional entity) (94),
B-lymphoblastic leukemia / lymphoma, with
iAMP21 (95),
T-cell lymphoblastic leukemia / lymphoma:
T-cell lymphoblastic leukemia / lymphoma
(Precursor T-cell ALL) (196),
Early T-cell precursor lymphoblastic leukemia
(96),NK cell lymphoblastic leukemia / lymphoma:
Natural killer (NK)- cell lymphoblastic leukemia /
lymphoma (97)
yes
no
Did the recipient have a predisposing
condition?
yes
no
Specify condition
no,Unknown,yes
Aplastic anemia,Bloom syndrome,Down
Syndrome,Fanconi anemia,Other
condition
yes
no
Specify other condition:
open text
yes
no
Were tyrosine kinase inhibitors given for
therapy at any time prior to the start of the
preparative regimen / infusion? (e.g.
imatinib mesylate, dasatinib, etc.)
no,yes
yes
yes
Were cytogenetics tested (karyotyping or
FISH)? (at diagnosis)
no,Unknown,yes
yes
yes
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
Results of tests
Abnormalities identified,No
abnormalities
Results of tests
Abnormalities identified,No abnormalities
yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Specify ALL classification
Did the recipient have a predisposing
condition?
no,Unknown,yes
Specify condition
Change/Clarification of Information Requested
Aplastic anemia,Bloom syndrome,Down
Syndrome,Fanconi anemia,Other condition
Specify other condition:
open text
Were tyrosine kinase inhibitors given
for therapy at any time prior to the
start of the preparative regimen /
infusion? (e.g. imatinib mesylate,
dasatinib, etc.)
no,yes
Were cytogenetics tested
(karyotyping or FISH)? (at diagnosis
or relapse)
no,Unknown,yes
Reduce redundancy in data capture
Page 20 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
yes
yes
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
yes
Specify number of distinct cytogenetic
abnormalities
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
open text
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
Specify number of distinct
cytogenetic abnormalities
Four or more (4 or more),One (1),Three (3),Two (2)
Specify other abnormality:
open text
Were cytogenetics tested via
karyotyping?
No,Yes
yes
yes
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8
yes
yes
Specify other abnormality:
(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8
open text
yes
yes
Were cytogenetics tested via karyotyping? No,Yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
yes
Specify number of distinct cytogenetic
abnormalities
Abnormalities identified,No
abnormalities,No evaluable metaphases
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
Specify number of distinct
cytogenetic abnormalities
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
yes
yes
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
yes
yes
Were tests for molecular markers
performed? (at diagnosis)
no,Unknown,yes
Were tests for molecular markers
performed? (at diagnosis or relapse) no,Unknown,yes
yes
yes
BCR / ABL
Negative,Not Done,Positive
BCR / ABL
Negative,Not Done,Positive
yes
yes
TEL-AML / AML1
Negative,Not Done,Positive
TEL-AML / AML1
Negative,Not Done,Positive
yes
yes
Other molecular marker
Negative,Not Done,Positive
Other molecular marker
Negative,Not Done,Positive
yes
yes
Specify other molecular marker:
open text
Specify other molecular marker:
open text
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
Four or more (4 or more),One (1),Three (3),Two (2)
(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8
Change/Clarification of Information Requested
open text
No,Yes
Reduce redundancy in data capture
Page 21 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
yes
yes
Were cytogenetics tested (karyotyping or
FISH)? (between diagnosis and last
evaluation)
yes
yes
Were cytogenetics tested via FISH?
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
yes
Specify number of distinct cytogenetic
abnormalities
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
no,Unknown,yes
Were cytogenetics tested
(karyotyping or FISH)? (between
diagnosis or at relapse and last
evaluation)
no,Unknown,yes
Reduce redundancy in data capture
No,Yes
Were cytogenetics tested via FISH?
No,Yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Abnormalities identified,No abnormalities
Abnormalities identified,No
abnormalities
open text
yes
yes
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8
yes
yes
Specify other abnormality:
yes
yes
Were cytogenetics tested via karyotyping? No,Yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
Specify number of distinct cytogenetic
abnormalities
Abnormalities identified,No
abnormalities,No evaluable metaphases
yes
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
yes
yes
Were tests for molecular markers
performed? (e.g. PCR, NGS) (between
diagnosis and last evaluation)
no,Unknown,yes
yes
yes
BCR / ABL
Negative,Not Done,Positive
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Specify number of distinct
cytogenetic abnormalities
Specify other abnormality:
open text
Were cytogenetics tested via
karyotyping?
No,Yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
yes
open text
Four or more (4 or more),One (1),Three (3),Two (2)
(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8
yes
Change/Clarification of Information Requested
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
Specify number of distinct
cytogenetic abnormalities
Specify other abnormality:
open text
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
No,Yes
Were tests for molecular markers
performed? (e.g. PCR, NGS) (between
diagnosis or relapse and last
evaluation)
no,Unknown,yes
Four or more (4 or more),One (1),Three (3),Two (2)
(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8
Change/Clarification of Information Requested
BCR / ABL
Reduce redundancy in data capture
Negative,Not Done,Positive
Page 22 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
yes
yes
TEL-AML / AML1
Negative,Not Done,Positive
TEL-AML / AML1
Negative,Not Done,Positive
yes
yes
Other molecular marker
Negative,Not Done,Positive
Other molecular marker
Negative,Not Done,Positive
yes
yes
Specify other molecular marker:
open text
open text
yes
yes
Were cytogenetics tested (karyotyping or
FISH)? (at last evaluation)
no,Unknown,yes
Specify other molecular marker:
Were cytogenetics tested
(karyotyping or FISH)? (at last
evaluation)
yes
yes
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Abnormalities identified,No abnormalities
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
yes
Specify number of distinct cytogenetic
abnormalities
Abnormalities identified,No
abnormalities
open text
yes
yes
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8
yes
yes
Specify other abnormality:
yes
yes
Were cytogenetics tested via karyotyping?
(at last evaluation)
No,Yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
yes
Specify number of distinct cytogenetic
abnormalities
open text
Abnormalities identified,No
abnormalities,No evaluable metaphases
open text
yes
yes
Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
no,Unknown,yes
open text
Specify number of distinct
cytogenetic abnormalities
Specify other abnormality:
open text
Were cytogenetics tested via
karyotyping? (at last evaluation)
No,Yes
Four or more (4 or more),One (1),Three (3),Two (2)
(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
Four or more (4 or more),One (1),Three (3),Two (2)
(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8
open text
No,Yes
Page 23 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Disease
Classification
Acute
Lymphoblastic
Leukemia (ALL)
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
yes
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
yes
Were tests for molecular markers
performed? (e.g. PCR, NGS) (at last
evaluation)
no,Unknown,yes
Were tests for molecular markers
performed? (e.g. PCR, NGS) (at last
evaluation)
no,Unknown,yes
yes
yes
BCR / ABL
Negative,Not Done,Positive
BCR / ABL
Negative,Not Done,Positive
yes
yes
TEL-AML / AML1
Negative,Not Done,Positive
TEL-AML / AML1
Negative,Not Done,Positive
yes
yes
Other molecular marker
Negative,Not Done,Positive
Other molecular marker
Negative,Not Done,Positive
yes
yes
Specify other molecular marker:
open text
yes
no
Specify other molecular marker:
open text
Did the recipient have central
nervous system leukemia at any time
prior to the start of the preparative
regimen / infusion?
no,Unknown,yes
Rationale for Information Collection Update
yes
no
yes
no
Did the recipient have central nervous
system leukemia at any time prior to the
start of the preparative regimen / infusion? no,Unknown,yes
1st complete remission (include CRi),1st
relapse,2nd complete remission,2nd
relapse, ≥ 3rd complete remission, ≥3rd
relapse,No treatment,Primary induction
What was the disease status?
failure
How many cycles of induction therapy
were required to achieve 1st complete
remission?
1,2, ≥ 3
yes
no
Was the recipient in remission by flow
cytometry?
yes
no
Addition of Information Requested
Was the recipient in remission by
flow cytometry?
Specify method(s) that was used to
assess measurable residual disease
status (check all that apply)
yes
no
Addition of Information Requested
Was measurable residual disease
detected by FISH?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Addition of Information Requested
Was measurable residual disease
detected by karyotyping assay?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Addition of Information Requested
yes
no
yes
Not applicable,No,Unknown,Yes
1st complete remission (include CRi),1st
relapse,2nd complete remission,2nd relapse, ≥ 3rd
complete remission, ≥3rd relapse,No
treatment,Primary induction failure
What was the disease status?
How many cycles of induction
therapy were required to achieve 1st
complete remission?
1,2, ≥ 3
Deletion of Information Requested
Not applicable,No,Unknown,Yes
Reduce redundancy in data capture
FISH, Karyotyping, Flow Cytometry, PCR, NGS, Not Be consistent with current clinical landscape, improve
assessed
transplant outcome data
Be consistent with current clinical landscape, improve
transplant outcome data
Addition of Information Requested
Which leukemia phenotype was used original leukemia immunophenotype, aberrant
for detection (check all the apply)
phenotype
What is the lower limit of detection
(for the original leukemia
immunophenotype)
open text
no
Addition of Information Requested
What is the lower limit of detection
(for the aberrant phenotype)
open text
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Addition of Information Requested
Was measurable residual disease
detected by flow cytometry?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Addition of Information Requested
Was measurable residual disease
detected by PCR?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Addition of Information Requested
Was measurable residual disease
detected by NGS?
no,yes
Be consistent with current clinical landscape, improve
transplant outcome data
yes
no
Date of most recent relapse:
YYYY/MM/DD
Date of most recent relapse:
YYYY/MM/DD
yes
no
Date assessed:
YYYY/MM/DD
Date assessed:
YYYY/MM/DD
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Be consistent with current clinical landscape, improve
transplant outcome data
Page 24 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Acute Leukemias
of Ambiguous
Lineage and Other
Myeloid
Neoplasms
yes
Acute Leukemias
of Ambiguous
Lineage and Other
Myeloid
Neoplasms
yes
Disease
Classification
Acute Leukemias
of Ambiguous
Lineage and Other
Myeloid
Neoplasms
Acute Leukemias
of Ambiguous
Lineage and Other
Myeloid
Neoplasms
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Disease
Classification
Chronic
Myelogenous
Leukemia (CML)
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Chronic
Myelogenous
Leukemia (CML)
no
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Specify acute leukemias of ambiguous
lineage and other myeloid neoplasm
classification
Acute undifferentiated leukemia,Blastic
plasmacytoid dendritic cell neoplasm
,Mixed phenotype acute leukemia,
B/myeloid, NOS,Mixed phenotype acute
leukemia (MPAL) with
t(9;22)(q34.1;q11.2); BCR-ABL1,Mixed
phenotype acute leukemia with t(v;
11q23.3); KMT2A rearranged,Mixed
phenotype acute leukemia, T/myeloid,
NOS,Other acute leukemia of ambiguous
lineage or myeloid neoplasm
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Specify acute leukemias of
ambiguous lineage and other
myeloid neoplasm classification
Acute undifferentiated leukemia,Blastic
plasmacytoid dendritic cell neoplasm ,Mixed
phenotype acute leukemia, B/myeloid, NOS,Mixed
phenotype acute leukemia (MPAL) with
t(9;22)(q34.1;q11.2); BCR-ABL1,Mixed phenotype
acute leukemia with t(v; 11q23.3); KMT2A
rearranged,Mixed phenotype acute leukemia,
T/myeloid, NOS,Other acute leukemia of
ambiguous lineage or myeloid neoplasm
Specify other acute leukemia of
ambiguous lineage or myeloid
neoplasm:
open text
yes
no
Specify other acute leukemia of ambiguous
lineage or myeloid neoplasm:
open text
1st complete remission (no previous
marrow or extramedullary relapse),1st
relapse,2nd complete remission,2nd
relapse, ≥ 3rd complete remission, ≥ 3rd
What was the disease status? (based on
relapse,No treatment,Primary induction
hematological test results)
failure
yes
no
Date assessed:
YYYY/MM/DD
Date assessed:
yes
no
Was therapy given prior to this HCT?
no,yes
Was therapy given prior to this HCT? no,yes
yes
no
Combination chemotherapy
no,yes
Combination chemotherapy
no,yes
yes
no
Hydroxyurea (Droxia, Hydrea)
no,yes
no,yes
yes
no
Tyrosine kinase inhibitor (e.g.imatinib
mesylate, dasatinib, nilotinib)
no,yes
Hydroxyurea (Droxia, Hydrea)
Tyrosine kinase inhibitor
(e.g.imatinib mesylate, dasatinib,
nilotinib)
yes
no
Interferon-α (Intron, Roferon)
(includes PEG)
no,yes
Interferon-α (Intron, Roferon)
(includes PEG)
no,yes
yes
no
Other therapy
no,yes
Other therapy
no,yes
yes
no
Specify other therapy:
Specify other therapy:
open text
What was the disease status?
open text
Accelerated phase,Blast phase,Complete
hematologic response (CHR) preceded
by accelerated phase and/or blast
phase,Complete hematologic response
(CHR) preceded only by chronic
phase,Chronic phase
What was the disease status?
Accelerated phase,Blast phase,Complete
hematologic response (CHR) preceded by
accelerated phase and/or blast phase,Complete
hematologic response (CHR) preceded only by
chronic phase,Chronic phase
Specify level of response
Complete cytogenetic response
(CCyR),Complete molecular remission
(CMR),Minimal cytogenetic
response,Minor cytogenetic
response,Major molecular remission
(MMR),No cytogenetic response (No
CyR),Partial cytogenetic response (PCyR)
Specify level of response
Complete cytogenetic response (CCyR),Complete
molecular remission (CMR),Minimal cytogenetic
response,Minor cytogenetic response,Major
molecular remission (MMR),No cytogenetic
response (No CyR),Partial cytogenetic response
(PCyR)
yes
yes
no
no
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
1st complete remission (no previous marrow or
extramedullary relapse),1st relapse,2nd complete
remission,2nd relapse, ≥ 3rd complete remission, ≥
What was the disease status? (based 3rd relapse,No treatment,Primary induction
on hematological test results)
failure
YYYY/MM/DD
no,yes
Page 25 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
yes
no
Number
1st,2nd,3rd or higher
Number
1st,2nd,3rd or higher
yes
no
Date assessed:
YYYY/MM/DD
Date assessed:
YYYY/MM/DD
yes
no
Atypical chronic myeloid leukemia
(aCML), BCR-ABL1-,Chronic
myelomonocytic leukemia
(CMMoL),Juvenile myelomonocytic
leukemia (JMML/JCML),Myelodysplastic
syndrome with isolated
del(5q),Myelodysplastic syndrome with
multilineage dysplasia (MDS-MLD),MDS
/ MPN with ring sideroblasts and
thrombocytosis (MDS / MPN-RST),Myelodysplastic syndrome /
myeloproliferative neoplasm,
unclassifiable, syndrome with single
lineage dysplasia (MDSSLD),Myelodysplastic syndrome (MDS),
unclassifiable,Refractory cytopenia of
childhood. Myelodysplatic Syndrome
with excess blasts (MDS-EB): MDS with
excess blasts-1 (MDS-EB-1),MDS with
excess blasts-2 (MDS-EB-2).
Myelodysplatic Syndrome with ring
What was the MDS subtype at diagnosis? - sideroblasts: MDS-RS with multilineage
If transformed to AML, indicate AML as
dysplasia (MDS-RS-MLD),MDS-RS with
primary disease; also complete AML
single lineage dysplasia (MDS-RSDisease Classification questions
SLD),Myelodysplastic
MDS-U with 1% blood blasts,MDS-U
based on defining cytogenetic
Specify Myelodysplastic syndrome,
abnormality,MDS-U with single lineage
unclassifiable (MDS-U)
dysplasia and pancytopenia
yes
no
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
yes
no
yes
no
yes
no
Was the disease MDS therapy related?
Did the recipient have a predisposing
condition?
No,Yes
no,Unknown,yes
no,Unknown,yes
Atypical chronic myeloid leukemia (aCML), BCRABL1-,Chronic myelomonocytic leukemia
(CMMoL),Juvenile myelomonocytic leukemia
(JMML/JCML),Myelodysplastic syndrome with
isolated del(5q),Myelodysplastic syndrome with
multilineage dysplasia (MDS-MLD),MDS / MPN
with ring sideroblasts and thrombocytosis (MDS /
MPN-RS-T),Myelodysplastic syndrome /
myeloproliferative neoplasm, unclassifiable,
syndrome with single lineage dysplasia (MDSSLD),Myelodysplastic syndrome (MDS),
unclassifiable,Refractory cytopenia of childhood.
Myelodysplatic Syndrome with excess blasts
(MDS-EB): MDS with excess blasts-1 (MDS-EBWhat was the MDS subtype at
1),MDS with excess blasts-2 (MDS-EB-2).
diagnosis? - If transformed to AML, Myelodysplatic Syndrome with ring sideroblasts:
indicate AML as primary disease; also MDS-RS with multilineage dysplasia (MDS-RScomplete AML Disease Classification MLD),MDS-RS with single lineage dysplasia (MDSquestions
RS-SLD),Myelodysplastic
Specify Myelodysplastic syndrome,
unclassifiable (MDS-U)
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Was the disease MDS therapy
related?
Did the recipient have a predisposing
condition?
MDS-U with 1% blood blasts,MDS-U based on
defining cytogenetic abnormality,MDS-U with
single lineage dysplasia and pancytopenia
No,Yes
no,Unknown,yes
no,Unknown,yes
yes
no
Specify condition
Aplastic anemia,DDX41-associated
familial MDS,Fanconi anemia,GATA2
deficiency (including Emberger
syndrome, MonoMac syndrome, DCML
deficiency) ,Li-Fraumeni Syndrome,Other
condition,Paroxysmal nocturnal
hemoglobinuria,Diamond-Blackfan
Anemia,RUNX1 deficiency (previously
“familial platelet disorder with
propensity to myeloid malignancies”)
,SAMD9- or SAMD9L-associated familial
MDS,Shwachman-Diamond
Syndrome,Telomere biology disorder
(including dyskeratosis congenita)
yes
no
Specify other condition:
open text
Specify other condition:
open text
yes
yes
Date CBC drawn:
YYYY/MM/DD
Date CBC drawn:
YYYY/MM/DD
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
Specify condition
Aplastic anemia,DDX41-associated familial
MDS,Fanconi anemia,GATA2 deficiency (including
Emberger syndrome, MonoMac syndrome, DCML
deficiency) ,Li-Fraumeni Syndrome,Other
condition,Paroxysmal nocturnal
hemoglobinuria,Diamond-Blackfan Anemia,RUNX1
deficiency (previously “familial platelet disorder
with propensity to myeloid malignancies”)
,SAMD9- or SAMD9L-associated familial
MDS,Shwachman-Diamond Syndrome,Telomere
biology disorder (including dyskeratosis congenita)
Page 26 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Disease
Classification
yes
Myelodysplastic
Syndrome (MDS)
yes
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
WBC
Known,Unknown
WBC
Known,Unknown
WBC
___ ___ ___ ___ ___ ___ ● ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L
9
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
yes
yes
WBC
___ ___ ___ ___ ___ ___ ● ___ x 10 /L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L
yes
yes
Neutrophils
Known,Unknown
Neutrophils
Known,Unknown
yes
yes
Neutrophils
___ ___%
Neutrophils
___ ___%
yes
yes
Blasts in blood
Known,Unknown
Blasts in blood
Known,Unknown
yes
yes
Blasts in blood
___ ___%
Blasts in blood
___ ___%
yes
yes
Hemoglobin
Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
Hemoglobin
Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
yes
yes
yes
yes
yes
yes
yes
yes
yes
At Diagnosis: Hemoglobin
Were RBCs transfused ≤ 30 days before
date of test?
g/dL
g/L
mmol/L
No,Yes
Known,Unknown
yes
Platelets
Were platelets transfused ≤ 7 days before
date of test?
Were platelets transfused ≤ 7 days before
date of test?
yes
yes
Blasts in bone marrow
yes
yes
yes
yes
Blasts in bone marrow
Were cytogenetics tested (karyotyping or
FISH)?
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct cytogenetic
abnormalities
yes
yes
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(3q) / 3q-,del(5q) / 5q-,del(7q) /
7q-,del(9q) / 9q-,del(13q) / 13q,i17q,inv(3),-13,-20,-5,-7,-Y,Other
abnormality,t(1;3),t(11;16),t(2;11),t(3;21
Specify abnormalities (check all that apply) ),t(3;3),t(6;9),+19,+8
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
yes
yes
yes
yes
At Diagnosis: Hemoglobin
Were RBCs transfused ≤ 30 days
before date of test?
Known,Unknown
No,Yes
Known,Unknown
Blasts in bone marrow
Known,Unknown
__ ___ ___%
g/dL
g/L
mmol/L
No,Yes
Platelets
Were platelets transfused ≤ 7 days
before date of test?
Were platelets transfused ≤ 7 days
before date of test?
No,Yes
No,Yes
No,Yes
__ ___ ___%
no,Unknown,yes
Blasts in bone marrow
Were cytogenetics tested
(karyotyping or FISH)?
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
Sample source
Peripheral blood,Bone marrow
Abnormalities identified,No
abnormalities
Sample source
Peripheral blood,Bone marrow
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities
Abnormalities identified,No abnormalities
open text
Were cytogenetics tested via karyotyping? No,Yes
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Were cytogenetics tested via
karyotyping?
yes
Sample source
Peripheral blood,Bone marrow
Sample source
Peripheral blood,Bone marrow
yes
Results of tests
Abnormalities identified,No
abnormalities,No evaluable metaphases
Results of tests
Abnormalities identified,No abnormalities,No
evaluable metaphases
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
no,Unknown,yes
open text
Four or more (4 or more),One (1),Three (3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,del(13q) / 13q-,i17q,inv(3),-13,-20,-5,-7,Y,Other
Specify abnormalities (check all that abnormality,t(1;3),t(11;16),t(2;11),t(3;21),t(3;3),t(
apply)
6;9),+19,+8
No,Yes
No,Yes
Page 27 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct cytogenetic
abnormalities
yes
yes
yes
yes
yes
yes
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(3q) / 3q-,del(5q) / 5q-,del(7q) /
7q-,del(9q) / 9q-,del(13q) / 13q,i17q,inv(3),-13,-20,-5,-7,-Y,Other
abnormality,t(1;3),t(11;16),t(2;11),t(3;21
Specify abnormalities (check all that apply) ),t(3;3),t(6;9),+19,+8
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
yes
Did the recipient progress or transform to
a different MDS subtype or AML between
diagnosis and the start of the preparative
regimen/ infusion?
No,Yes
yes
yes
yes
Specify the MDS subtype or AML after
transformation
yes
yes
yes
yes
Specify Myelodysplastic syndrome,
unclassifiable (MDS-U)
Specify the date of the most recent
transformation:
yes
yes
yes
yes
yes
Transformed to AML,Chronic
myelomonocytic leukemia
(CMMoL),Myelodysplastic syndrome
with isolated del(5q),Myelodysplastic
syndrome with multilineage dysplasia
(MDS-MLD),MDS / MPN with ring
sideroblasts and thrombocytosis (MDS /
MPN-RS-T),Myelodysplastic syndrome /
myeloproliferative neoplasm,
unclassifiable,Myelodysplastic syndrome
with single lineage dysplasia (MDSSLD),Myelodysplastic syndrome (MDS),
unclassifiable,Refractory cytopenia of
childhood. Myelodysplatic Syndrome
with excess blasts (MDS-EB): MDS with
excess blasts-1 (MDS-EB-1),MDS with
excess blasts-2 (MDS-EB-2).
Myelodysplatic syndrome with ring
sideroblasts: MDS-RS with multilineage
dysplasia (MDS-RS-MLD),MDS-RS with
single lineage dysplasia (MDS-RS-SLD).
MDS-U with 1% blood blasts,MDS-U
based on defining cytogenetic
abnormality,MDS-U with single lineage
dysplasia and pancytopenia
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities
open text
Four or more (4 or more),One (1),Three (3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,del(13q) / 13q-,i17q,inv(3),-13,-20,-5,-7,Y,Other
Specify abnormalities (check all that abnormality,t(1;3),t(11;16),t(2;11),t(3;21),t(3;3),t(
apply)
6;9),+19,+8
Specify other abnormality:
open text
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
No,Yes
Did the recipient progress or
transform to a different MDS subtype
or AML between diagnosis and the
start of the preparative regimen/
infusion?
No,Yes
Specify the MDS subtype or AML
after transformation
Transformed to AML,Chronic myelomonocytic
leukemia (CMMoL),Myelodysplastic syndrome
with isolated del(5q),Myelodysplastic syndrome
with multilineage dysplasia (MDS-MLD),MDS /
MPN with ring sideroblasts and thrombocytosis
(MDS / MPN-RS-T),Myelodysplastic syndrome /
myeloproliferative neoplasm,
unclassifiable,Myelodysplastic syndrome with
single lineage dysplasia (MDSSLD),Myelodysplastic syndrome (MDS),
unclassifiable,Refractory cytopenia of childhood.
Myelodysplatic Syndrome with excess blasts
(MDS-EB): MDS with excess blasts-1 (MDS-EB1),MDS with excess blasts-2 (MDS-EB-2).
Myelodysplatic syndrome with ring sideroblasts:
MDS-RS with multilineage dysplasia (MDS-RSMLD),MDS-RS with single lineage dysplasia (MDSRS-SLD).
MDS-U with 1% blood blasts,MDS-U based on
defining cytogenetic abnormality,MDS-U with
single lineage dysplasia and pancytopenia
YYYY/MM/DD
Specify Myelodysplastic syndrome,
unclassifiable (MDS-U)
Specify the date of the most recent
transformation:
Date of MDS diagnosis:
YYYY/MM/DD
Date of MDS diagnosis:
YYYY/MM/DD
Date CBC drawn:
YYYY/MM/DD
Date CBC drawn:
YYYY/MM/DD
yes
WBC
Known,Unknown
WBC
Known,Unknown
yes
yes
Neutrophils
Known,Unknown
Neutrophils
Known,Unknown
yes
yes
Neutrophils
___ ___%
Neutrophils
___ ___%
yes
yes
Blasts in blood
Known,Unknown
Blasts in blood
Known,Unknown
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
YYYY/MM/DD
Page 28 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
yes
yes
Blasts in blood
___ ___%
Blasts in blood
___ ___%
yes
yes
Hemoglobin
Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
Hemoglobin
Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
yes
yes
yes
yes
Prior to Infusion: Hemoglobin
Were RBCs transfused ≤ 30 days before
date of test?
yes
yes
Platelets
g/dL
g/L
mmol/L
No,Yes
Known,Unknown
Prior to Infusion: Hemoglobin
Were RBCs transfused ≤ 30 days
before date of test?
Rationale for Information Collection Update
g/dL
g/L
mmol/L
No,Yes
Platelets
Known,Unknown
Platelets
___ ___ ___ ___ ___ ___ ___ x 10 /L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L
Platelets
___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L
Platelets
___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L
Blasts in bone marrow
Known,Unknown
9
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
yes
yes
yes
yes
Platelets
___ ___ ___ ___ ___ ___ ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L
yes
yes
Blasts in bone marrow
Known,Unknown
yes
yes
yes
yes
Blasts in bone marrow
Were cytogenetics tested (karyotyping or
FISH)?
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct cytogenetic
abnormalities
yes
yes
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(3q) / 3q-,del(5q) / 5q-,del(7q) /
7q-,del(9q) / 9q-,del(13q) / 13q,i17q,inv(3),-13,-20,-5,-7,-Y,Other
abnormality,t(1;3),t(11;16),t(2;11),t(3;21
Specify abnormalities (check all that apply) ),t(3;3),t(6;9),+19,+8
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
yes
yes
yes
__ ___ ___%
__ ___ ___%
no,Unknown,yes
Blasts in bone marrow
Were cytogenetics tested
(karyotyping or FISH)?
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
Sample source
Peripheral blood,Bone marrow
Abnormalities identified,No
abnormalities
Sample source
Peripheral blood,Bone marrow
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities
Abnormalities identified,No abnormalities
open text
Were cytogenetics tested via karyotyping? No,Yes
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Were cytogenetics tested via
karyotyping?
yes
Sample source
Sample source
Peripheral blood,Bone marrow
yes
yes
yes
yes
yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct cytogenetic
abnormalities
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Peripheral blood,Bone marrow
Abnormalities identified,No
abnormalities,No evaluable metaphases
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
no,Unknown,yes
open text
Four or more (4 or more),One (1),Three (3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,del(13q) / 13q-,i17q,inv(3),-13,-20,-5,-7,Y,Other
Specify abnormalities (check all that abnormality,t(1;3),t(11;16),t(2;11),t(3;21),t(3;3),t(
apply)
6;9),+19,+8
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities
No,Yes
No,Yes
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
Four or more (4 or more),One (1),Three (3),Two (2)
Page 29 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
yes
yes
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(3q) / 3q-,del(5q) / 5q-,del(7q) /
7q-,del(9q) / 9q-,del(13q) / 13q,i17q,inv(3),-13,-20,-5,-7,-Y,Other
abnormality,t(1;3),t(11;16),t(2;11),t(3;21
Specify abnormalities (check all that apply) ),t(3;3),t(6;9),+19,+8
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,del(13q) / 13q-,i17q,inv(3),-13,-20,-5,-7,Y,Other
Specify abnormalities (check all that abnormality,t(1;3),t(11;16),t(2;11),t(3;21),t(3;3),t(
apply)
6;9),+19,+8
yes
yes
Specify other abnormality:
open text
yes
yes
Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
No,Yes
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Complete remission (CR),Hematologic
improvement (HI),Not assessed,No
response (NR) / stable disease
(SD),Progression from hematologic
improvement (Prog from HI),Relapse
from complete remission (Rel from CR)
yes
no
yes
no
yes
no
What was the disease status?
Specify the cell line examined to determine
HI status
HI-E,HI-N,HI-P
Low-transfusion burden (LTB),NonSpecify transfusion dependence
transfused (NTD)
yes
no
Date assessed:
Myeloproliferative
Neoplasms (MPN) yes
no
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
What was the MPN subtype at diagnosis?
Specify systemic mastocytosis
Was documentation submitted to the
CIBMTR? (e.g. pathology report used for
diagnosis)
YYYY/MM/DD
Chronic eosinophilic leukemia, not
otherwise specified (NOS),Primary
myelofibrosis (PMF),Chronic neutrophilic
leukemia,,Essential
thrombocythemia,Myeloproliferative
neoplasm (MPN), unclassifiable,Myeloid
/ lymphoid neoplasms with FGFR1
rearrangement,Myeloid / lymphoid
neoplasms with PCM1-JAK2,Myeloid /
lymphoid neoplasms with PDGFRA
rearrangement,Myeloid / lymphoid
neoplasms with PDGFRB
rearrangement,Polycythemia vera
(PCV),Mastocytosis: Cutaneous
mastocytosis (CM), Systemic
mastocytosis, Mast cell sarcoma (MCS)
Aggressive systemic mastocytosis
(ASM),Indolent systemic mastocytosis
(ISM),Mast cell leukemia (MCL),Systemic
mastocytosis with an associated
hematological neoplasm (SMAHN),Smoldering systemic mastocytosis
(SSM)
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Did the recipient have constitutional
symptoms in six months before diagnosis?
(symptoms are >10% weight loss in 6
months, night sweats, or unexplained fever
higher than 37.5 °C)
No,Unknown,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Date CBC drawn:
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
YYYY/MM/DD
Change/Clarification of Information Requested
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
What was the disease status?
Specify the cell lines examined to
determine HI status
open text
No,Yes
Complete remission (CR),Hematologic
improvement (HI),Not assessed,No response (NR) /
stable disease (SD),Progression from hematologic
improvement (Prog from HI),Relapse from
complete remission (Rel from CR)
Specify transfusion dependence
HI-E,HI-N,HI-P
Low-transfusion burden (LTB),Non-transfused
(NTD)
Date assessed:
YYYY/MM/DD
What was the MPN subtype at
diagnosis?
Chronic eosinophilic leukemia, not otherwise
specified (NOS),Primary myelofibrosis
(PMF),Chronic neutrophilic leukemia,,Essential
thrombocythemia,Myeloproliferative neoplasm
(MPN), unclassifiable,Myeloid / lymphoid
neoplasms with FGFR1 rearrangement,Myeloid /
lymphoid neoplasms with PCM1-JAK2,Myeloid /
lymphoid neoplasms with PDGFRA
rearrangement,Myeloid / lymphoid neoplasms
with PDGFRB rearrangement,Polycythemia vera
(PCV),Mastocytosis: Cutaneous mastocytosis
(CM), Systemic mastocytosis, Mast cell sarcoma
(MCS)
Specify systemic mastocytosis
Was documentation submitted to
the CIBMTR? (e.g. pathology report
used for diagnosis)
Rationale for Information Collection Update
Examples added or typographical errors corrected for
clarification
Aggressive systemic mastocytosis (ASM),Indolent
systemic mastocytosis (ISM),Mast cell leukemia
(MCL),Systemic mastocytosis with an associated
hematological neoplasm (SM-AHN),Smoldering
systemic mastocytosis (SSM)
No,Yes
Did the recipient have constitutional
symptoms in six months before
diagnosis? (symptoms are >10%
weight loss in 6 months, night
sweats, or unexplained fever higher
than 37.5 °C)
No,Unknown,Yes
Date CBC drawn:
YYYY/MM/DD
Page 30 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Myeloproliferative
Neoplasms (MPN) yes
yes
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
WBC
Known,Unknown
WBC
Known,Unknown
WBC
___ ___ ___ ___ ___ ___ ● ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L
9
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
WBC
___ ___ ___ ___ ___ ___ ● ___ x 10 /L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Neutrophils
Known,Unknown
Neutrophils
Known,Unknown
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Neutrophils
___ ___%
Neutrophils
___ ___%
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Blasts in blood
Known,Unknown
Blasts in blood
Known,Unknown
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Blasts in blood
___ ___%
Blasts in blood
___ ___%
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Hemoglobin
Myeloproliferative
Neoplasms (MPN) yes
yes
Hemoglobin
Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
Hemoglobin
Disease
Classification
Hemoglobin
Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were RBCs transfused ≤ 30 days before
date of test?
No,Yes
Were RBCs transfused ≤ 30 days
before date of test?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Platelets
Known,Unknown
Platelets
Known,Unknown
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Platelets
___ ___ ___ ___ ___ ___ ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L
Platelets
___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were platelets transfused ≤ 7 days before
date of test?
No,Yes
Were platelets transfused ≤ 7 days
before date of test?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Blasts in bone marrow
Known,Unknown
Blasts in bone marrow
Known,Unknown
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Blasts in bone marrow
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were tests for driver mutations
performed?
No,Unknown,Yes
Were tests for driver mutations
performed?
No,Unknown,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
JAK2
Negative,Not done,Positive
JAK2
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
JAK2 V617F
Negative,Not done,Positive
JAK2 V617F
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
JAK2 Exon 12
Negative,Not done,Positive
JAK2 Exon 12
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
CALR
Negative,Not done,Positive
CALR
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
CALR type 1
Negative,Not done,Positive
CALR type 1
Negative,Not done,Positive
g/dL
g/L
mmol/L
__ ___ ___%
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
g/dL
g/L
mmol/L
__ ___ ___%
Blasts in bone marrow
Page 31 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
CALR type 2
Negative,Not done,Positive
CALR type 2
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Not defined
Negative,Not done,Positive
Not defined
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
MPL
Negative,Not done,Positive
MPL
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
CSF3R
Negative,Not done,Positive
CSF3R
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Was documentation submitted to the
CIBMTR?
No,Yes
Was documentation submitted to
the CIBMTR?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were cytogenetics tested (karyotyping or
FISH)?
no,Unknown,yes
Were cytogenetics tested
(karyotyping or FISH)?
no,Unknown,yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Sample source
Peripheral blood,Bone marrow
Sample source
Peripheral blood,Bone marrow
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Myeloproliferative
Neoplasms (MPN) yes
yes
open text
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Abnormalities identified,No abnormalities
Disease
Classification
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Specify number of distinct cytogenetic
abnormalities
Four or more (4 or more),One (1),Three
(3),Two (2)
Specify number of distinct
cytogenetic abnormalities
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(5q) / 5q-,del(7q) / 7q-,del(13q) / 13q,dup(1),i17q,inv(3),-5,-7,-Y,Other
Specify abnormalities (check all that abnormality,t(1;any),t(11q23;any),t(12p11.2;any),
apply)
t(3q21;any),t(6;9),+8,+9
Abnormalities identified,No
abnormalities
open text
Four or more (4 or more),One (1),Three (3),Two (2)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(5q) / 5q-,del(7q) / 7q-,del(13q)
/ 13q-,dup(1),i17q,inv(3),-5,-7,-Y,Other
abnormality,t(1;any),t(11q23;any),t(12p
Specify abnormalities (check all that apply) 11.2;any),t(3q21;any),t(6;9),+8,+9
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Specify other abnormality:
open text
Specify other abnormality:
open text
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Was documentation submitted to the
CIBMTR? (e.g. FISH report)
No,Yes
Was documentation submitted to
the CIBMTR? (e.g. FISH report)
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were cytogenetics tested via karyotyping? No,Yes
Were cytogenetics tested via
karyotyping?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Sample source
Sample source
Peripheral blood,Bone marrow
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Specify number of distinct cytogenetic
abnormalities
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Peripheral blood,Bone marrow
Abnormalities identified,No
abnormalities,No evaluable metaphases
open text
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Four or more (4 or more),One (1),Three
(3),Two (2)
Specify number of distinct
cytogenetic abnormalities
Rationale for Information Collection Update
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
Four or more (4 or more),One (1),Three (3),Two (2)
Page 32 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(5q) / 5q-,del(7q) / 7q-,del(13q)
/ 13q-,dup(1),i17q,inv(3),-5,-7,-Y,Other
abnormality,t(1;any),t(11q23;any),t(12p
Specify abnormalities (check all that apply) 11.2;any),t(3q21;any),t(6;9),+8,+9
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Specify other abnormality:
open text
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Was documentation submitted to the
CIBMTR? (e.g. karyotyping report)
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Did the recipient progress or transform to
a different MPN subtype or AML between
diagnosis and the start of the preparative
regimen / infusion?
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the MPN subtype or AML after
transformation
No,Yes
Transformed to AML,Post-essential
thrombocythemic myelofibrosis,Postpolycythemic myelofibrosis
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the date of the most recent
transformation:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(5q) / 5q-,del(7q) / 7q-,del(13q) / 13q,dup(1),i17q,inv(3),-5,-7,-Y,Other
Specify abnormalities (check all that abnormality,t(1;any),t(11q23;any),t(12p11.2;any),
apply)
t(3q21;any),t(6;9),+8,+9
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. karyotyping
report)
Did the recipient progress or
transform to a different MPN
subtype or AML between diagnosis
and the start of the preparative
regimen / infusion?
open text
No,Yes
Specify the MPN subtype or AML
after transformation
No,Yes
Transformed to AML,Post-essential
thrombocythemic myelofibrosis,Post-polycythemic
myelofibrosis
YYYY/MM/DD
Specify the date of the most recent
transformation:
YYYY/MM/DD
Date of MPN diagnosis:
YYYY/MM/DD
Date of MPN diagnosis:
YYYY/MM/DD
no
Specify transfusion dependence at last
evaluation prior to the start of the
preparative regimen / infusion
High-transfusion burden (HTB)- (≥ 8 RBCs
in 16weeks; ≥ 4 in 8 weeks),Lowtransfusion burden (LTB)-(3-7 RBCs in 16
weeks in at least 2 transfusion episodes;
maximum of 3 in 8 weeks),Nontransfused (NTD) –(0 RBCs in 16 weeks)
yes
Did the recipient have constitutional
symptoms in six months before last
evaluation prior to the start of the
preparative regimen / infusion? (symptoms
are >10% weight loss in 6 months, night
sweats, or unexplained fever higher than
37.5 °C)
No,Unknown,Yes
Specify transfusion dependence at
last evaluation prior to the start of
the preparative regimen / infusion
Did the recipient have constitutional
symptoms in six months before last
evaluation prior to the start of the
preparative regimen / infusion?
(symptoms are >10% weight loss in 6
months, night sweats, or
unexplained fever higher than 37.5
°C)
No,Unknown,Yes
Did the recipient have splenomegaly
at last evaluation prior to the start of
the preparative regimen / infusion? No,Not applicable(splenectomy) ,Unknown,Yes
Specify the method used to measure
spleen size
CT/MRI scan,Physical exam,Ultrasound
High-transfusion burden (HTB)- (≥ 8 RBCs in
16weeks; ≥ 4 in 8 weeks),Low-transfusion burden
(LTB)-(3-7 RBCs in 16 weeks in at least 2
transfusion episodes; maximum of 3 in 8
weeks),Non-transfused (NTD) –(0 RBCs in 16
weeks)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Did the recipient have splenomegaly at last
evaluation prior to the start of the
No,Not applicable(splenectomy)
preparative regimen / infusion?
,Unknown,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the method used to measure
spleen size
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the spleen size:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the spleen size:
Specify the spleen size:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Did the recipient have hepatomegaly at
last evaluation prior to the start of the
preparative regimen / infusion?
no,Unknown,yes
Did the recipient have hepatomegaly
at last evaluation prior to the start of
the preparative regimen / infusion? no,Unknown,yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the method used to measure liver
size
CT/MRI scan,Physical exam,Ultrasound
Specify the method used to measure
liver size
CT/MRI scan,Physical exam,Ultrasound
CT/MRI scan,Physical exam,Ultrasound
: ___ ___ centimeters below left costal
margin
: ___ ___ centimeters below left costal margin
Specify the spleen size:
:___ ___ centimeters
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
:___ ___ centimeters
Page 33 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
: ___ ___ centimeters below right costal
margin
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the liver size:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the liver size:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Date CBC drawn:
YYYY/MM/DD
Date CBC drawn:
YYYY/MM/DD
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
WBC
Known,Unknown
WBC
Known,Unknown
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
WBC
___ ___ ___ ___ ___ ___ ● ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L
WBC
___ ___ ___ ___ ___ ___ ● ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Neutrophils
Known,Unknown
Neutrophils
Known,Unknown
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Neutrophils
___ ___%
Neutrophils
___ ___%
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Blasts in blood
Known,Unknown
Blasts in blood
Known,Unknown
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Blasts in blood
___ ___%
Blasts in blood
___ ___%
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Hemoglobin
Hemoglobin
Hemoglobin
Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
Were RBCs transfused ≤ 30 days
before date of test?
No,Yes
Platelets
Known,Unknown
Platelets
___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L
Rationale for Information Collection Update
: ___ ___ centimeters below right costal margin
Specify the liver size:
: ___ ___ centimeters
: ___ ___ centimeters
Specify the liver size:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Hemoglobin
Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were RBCs transfused ≤ 30 days before
date of test?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Platelets
Known,Unknown
g/dL
g/L
mmol/L
g/dL
g/L
mmol/L
9
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Platelets
___ ___ ___ ___ ___ ___ ___ x 10 /L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were platelets transfused ≤ 7 days before
date of test?
No,Yes
Were platelets transfused ≤ 7 days
before date of test?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Blasts in bone marrow
Known,Unknown
Blasts in bone marrow
Known,Unknown
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Blasts in bone marrow
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were tests for driver mutations
performed?
No,Unknown,Yes
Were tests for driver mutations
performed?
No,Unknown,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
JAK2
Negative,Not done,Positive
JAK2
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
JAK2 V617F
Negative,Not done,Positive
JAK2 V617F
Negative,Not done,Positive
__ ___ ___%
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
__ ___ ___%
Blasts in bone marrow
Page 34 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
JAK2 Exon 12
Negative,Not done,Positive
JAK2 Exon 12
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
CALR
Negative,Not done,Positive
CALR
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
CALR type 1
Negative,Not done,Positive
CALR type 1
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
CALR type 2
Negative,Not done,Positive
CALR type 2
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Not defined
Negative,Not done,Positive
Not defined
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
MPL
Negative,Not done,Positive
MPL
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
CSF3R
Negative,Not done,Positive
CSF3R
Negative,Not done,Positive
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Was documentation submitted to the
CIBMTR?
No,Yes
Was documentation submitted to
the CIBMTR?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were cytogenetics tested (karyotyping or
FISH)?
no,Unknown,yes
Were cytogenetics tested
(karyotyping or FISH)?
no,Unknown,yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Sample source
Peripheral blood,Bone marrow
Sample source
Peripheral blood,Bone marrow
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Myeloproliferative
Neoplasms (MPN) yes
yes
open text
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Abnormalities identified,No abnormalities
Disease
Classification
Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Specify number of distinct cytogenetic
abnormalities
Four or more (4 or more),One (1),Three
(3),Two (2)
Specify number of distinct
cytogenetic abnormalities
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(5q) / 5q-,del(7q) / 7q-,del(13q) / 13q,dup(1),i17q,inv(3),-5,-7,-Y,Other
Specify abnormalities (check all that abnormality,t(1;any),t(11q23;any),t(12p11.2;any),
apply)
t(3q21;any),t(6;9),+8,+9
open text
Specify other abnormality:
open text
No,Yes
Was documentation submitted to
the CIBMTR? (e.g. FISH report)
No,Yes
Abnormalities identified,No
abnormalities
open text
Four or more (4 or more),One (1),Three (3),Two (2)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(5q) / 5q-,del(7q) / 7q-,del(13q)
/ 13q-,dup(1),i17q,inv(3),-5,-7,-Y,Other
abnormality,t(1;any),t(11q23;any),t(12p
Specify abnormalities (check all that apply) 11.2;any),t(3q21;any),t(6;9),+8,+9
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Specify other abnormality:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Was documentation submitted to the
CIBMTR? (e.g. FISH report)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Were cytogenetics tested via karyotyping? No,Yes
Were cytogenetics tested via
karyotyping?
No,Yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Sample source
Peripheral blood,Bone marrow
Sample source
Peripheral blood,Bone marrow
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Results of tests
Abnormalities identified,No
abnormalities,No evaluable metaphases
Results of tests
Abnormalities identified,No abnormalities,No
evaluable metaphases
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
Page 35 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
open text
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
Four or more (4 or more),One (1),Three
(3),Two (2)
Specify number of distinct
cytogenetic abnormalities
Four or more (4 or more),One (1),Three (3),Two (2)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Specify number of distinct cytogenetic
abnormalities
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(5q) / 5q-,del(7q) / 7q-,del(13q) / 13q,dup(1),i17q,inv(3),-5,-7,-Y,Other
Specify abnormalities (check all that abnormality,t(1;any),t(11q23;any),t(12p11.2;any),
apply)
t(3q21;any),t(6;9),+8,+9
Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. karyotyping
report)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(5q) / 5q-,del(7q) / 7q-,del(13q)
/ 13q-,dup(1),i17q,inv(3),-5,-7,-Y,Other
abnormality,t(1;any),t(11q23;any),t(12p
Specify abnormalities (check all that apply) 11.2;any),t(3q21;any),t(6;9),+8,+9
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Specify other abnormality:
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
yes
Was documentation submitted to the
CIBMTR? (e.g. karyotyping report)
open text
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
What was the disease status?
No,Yes
Clinical improvement (CI),Complete
clinical remission (CR),Not
assessed,Partial clinical remission
(PR),Progressive disease,Relapse,Stable
disease (SD)
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Was an anemia response achieved?
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
open text
No,Yes
What was the disease status?
Clinical improvement (CI),Complete clinical
remission (CR),Not assessed,Partial clinical
remission (PR),Progressive disease,Relapse,Stable
disease (SD)
No,Yes
Was an anemia response achieved?
No,Yes
Was a spleen response achieved?
No,Yes
Was a spleen response achieved?
No,Yes
no
Was a symptom response achieved?
No,Yes
Was a symptom response achieved? No,Yes
no
Date assessed:
Date assessed:
YYYY/MM/DD
Specify the cytogenetic response
Complete response (CR Eradication of pre-existing
abnormality,Not assessed,Not applicable,None of
the above: Does not meet the CR or PR criteria,
Partial response (PR) ≥ 50% reduction in abnormal
metaphases ,Re-emergence of pre-existing
cytogenetic abnormality
Date assessed:
YYYY/MM/DD
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the cytogenetic response
YYYY/MM/DD
Complete response (CR Eradication of
pre-existing abnormality,Not
assessed,Not applicable,None of the
above: Does not meet the CR or PR
criteria, Partial response (PR) ≥ 50%
reduction in abnormal metaphases ,Reemergence of pre-existing cytogenetic
abnormality
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Date assessed:
YYYY/MM/DD
Specify the molecular response
Complete response (CR): Eradication of preexisting abnormality ,Not assessed,Not
applicable,None of the above: Does not meet the
CR or PR criteria ,Partial response (PR): ≥50%
decrease in allele burden ,Re-emergence of a preexisting molecular abnormality
Date assessed:
YYYY/MM/DD
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Specify the molecular response
Complete response (CR): Eradication of
pre-existing abnormality ,Not
assessed,Not applicable,None of the
above: Does not meet the CR or PR
criteria ,Partial response (PR): ≥50%
decrease in allele burden ,Re-emergence
of a pre-existing molecular abnormality
Disease
Classification
Myeloproliferative
Neoplasms (MPN) yes
no
Date assessed:
YYYY/MM/DD
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
Page 36 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Other Leukemia
(OL)
Other Leukemia
(OL)
Other Leukemia
(OL)
Disease
Classification
Other Leukemia
(OL)
Disease
Classification
Other Leukemia
(OL)
Disease
Classification
Disease
Classification
Other Leukemia
(OL)
Other Leukemia
(OL)
Disease
Classification
Disease
Classification
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Specify the other leukemia
classification
Chronic lymphocytic leukemia (CLL), NOS,Chronic
lymphocytic leukemia (CLL), B-cell / small
lymphocytic lymphoma (SLL),Hairy cell
leukemia,Hairy cell leukemia variant,Monoclonal Bcell lymphocytosis,Other leukemia,Other
leukemia, NOS,PLL, B-cell,Prolymphocytic
leukemia (PLL), NOS,PLL, T-cell
open text
yes
no
Specify the other leukemia classification
Chronic lymphocytic leukemia (CLL),
NOS,Chronic lymphocytic leukemia (CLL),
B-cell / small lymphocytic lymphoma
(SLL),Hairy cell leukemia,Hairy cell
leukemia variant,Monoclonal B-cell
lymphocytosis,Other leukemia,Other
leukemia, NOS,PLL, Bcell,Prolymphocytic leukemia (PLL),
NOS,PLL, T-cell
yes
no
Specify other leukemia:
open text
Specify other leukemia:
yes
no
Was any 17p abnormality detected?
no,yes
no
Did a histologic transformation to diffuse
large B-cell lymphoma (Richter syndrome)
occur at any time after CLL diagnosis?
no,yes
Was any 17p abnormality detected? no,yes
Did a histologic transformation to
diffuse large B-cell lymphoma
(Richter syndrome) occur at any time
after CLL diagnosis?
no,yes
yes
Rationale for Information Collection Update
no
What was the disease status? (Atypical
CML)
yes
no
What was the disease status? (CLL, PLL,
Hairy cell leukemia, Other leukemia)
1st complete remission (no previous
bone marrow or extramedullary
relapse),1st relapse,2nd complete
remission,2nd relapse,≥3rd complete
remission,≥3rd relapse,No
treatment,Primary induction failure
Complete remission (CR),Not
assessed,Untreated,Partial remission
(PR),Progressive disease (Prog),Stable
disease (SD)
yes
no
Date assessed:
YYYY/MM/DD
Hodgkin
Lymphoma
Date assessed:
no
Specify the lymphoma histology
Hodgkin lymphoma, not otherwise
specified (150)
Lymphocyte depleted (154)
Lymphocyte-rich (151)
Mixed cellularity (153)
Nodular lymphocyte predominant
Hodgkin lymphoma (155)
Nodular sclerosis (152)
Non-Hodgkin Lymphoma
B-cell Neoplasms
ALK+ large B-cell lymphoma (1833)
B-cell lymphoma, unclassifiable, with
features intermediate between DLBCL
and classical Hodgkin lymphoma (149)
Burkitt lymphoma (111)
Burkitt-like lymphoma with 11q
aberration (1834)
Diffuse, large B-cell lymphomaActivated B-cell type (non-GCB) (1821)
Diffuse, large B-cell lymphoma- Germinal
center B-cell type (1820)
Diffuse large B-cell Lymphoma (cell of
origin unknown) (107)
DLBCL associated with chronic
inflammation (1825)
Duodenal-type follicular lymphoma
(1815)
Change/Clarification of Response Options
Specify the lymphoma histology
YYYY/MM/DD
Classical
Hodgkin Lymphoma
Lymphocyte depleted (154)
Lymphocyte-rich (151)
Mixed cellularity (153)
Nodular sclerosis (152)
Other Classical Hodgkin Lymphoma
Hodgkin lymphoma, not otherwise specified (150)
Nodular lymphocyte predominant Hodgkin
lymphoma
Non-Hodgkin
Lymphoma
B-cell Neoplasms
ALK+ large B-cell lymphoma (1833)
B-cell lymphoma, unclassifiable, with features
intermediate between DLBCL and classical
Hodgkin lymphoma (149)
Burkitt lymphoma (111)
Burkitt-like lymphoma with 11q aberration (1834)
Diffuse, large B-cell lymphoma- Activated B-cell
type (non-GCB) (1821)
Diffuse, large B-cell lymphoma- Germinal center Bcell type (1820)
Diffuse large B-cell Lymphoma (cell of origin
unknown) (107)
DLBCL associated with chronic inflammation
(1825)
Duodenal-type follicular lymphoma (1815)
EBV+ DLBCL, NOS (1823)
EBV+ mucocutaneous ulcer (1824)
Be consistent with current clinical landscape, improve
Extranodal marginal zone B-cell lymphoma of
transplant outcome data
no
Specify other lymphoma histology:
open text
Specify other lymphoma histology:
open text
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
What was the disease status?
(Atypical CML)
1st complete remission (no previous bone marrow
or extramedullary relapse),1st relapse,2nd
complete remission,2nd relapse,≥3rd complete
remission,≥3rd relapse,No treatment,Primary
induction failure
What was the disease status? (CLL,
PLL, Hairy cell leukemia, Other
leukemia)
Complete remission (CR),Not
assessed,Untreated,Partial remission
(PR),Progressive disease (Prog),Stable disease (SD)
Page 37 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Disease
Classification
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Disease
Classification
Hodgkin and NonHodgkin
Lymphoma
yes
Disease
Classification
Disease
Classification
Disease
Classification
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Disease
Classification
Hodgkin and NonHodgkin
Lymphoma
yes
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Hodgkin and NonHodgkin
Lymphoma
Hodgkin and NonHodgkin
Lymphoma
Hodgkin and NonHodgkin
Lymphoma
Hodgkin and NonHodgkin
Lymphoma
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
no
Assignment of DLBCL (germinal center Bcell type vs. activated B-cell type) subtype
was based on
Gene expression
profile,Immunohistochemistry (e.g.
Han’s algorithm),Unknown
no
Is the lymphoma histology reported at
transplant a transformation from CLL?
no,yes
Assignment of DLBCL (germinal
center B-cell type vs. activated B-cell
type) subtype was based on
Is the lymphoma histology reported
at transplant a transformation from
CLL?
Capture additional relevent disease information
no
Was any 17p abnormality detected?
no,yes
no
Is the lymphoma histology reported at
transplant a transformation from a
different lymphoma histology? (Not CLL)
no
Change/Clarification of Response Options
Gene expression profile,Immunohistochemistry
(e.g. Han’s algorithm),Unknown
no,yes (Also complete Chronic Lymphocytic
Leukemia (CLL) )
Specify the original lymphoma histology
(prior to transformation)
No,Yes
Aggressive NK-cell leukemia,Anaplastic
large-cell lymphoma (ALCL), ALK
negative,Anaplastic large-cell lymphoma
(ALCL), ALK positive,Angioimmunoblastic
T-cell lymphoma,Adult T-cell lymphoma
/ leukemia (HTLV1 associated),Breast
implant-associated anaplastic large-cell
lymphoma,Burkitt-like lymphoma with
11q aberration,Chronic
lymphoproliferative disorder of NK
cells,Diffuse, Large B-cell Lymphoma (cell
of origin unknown),B-cell lymphoma,
unclassifiable, with features
intermediate between DLBCL and
classical Hodgkin Lymphoma,DLBCL
associated with chronic
inflammation,EBV+ DLBCL, NOS,Diffuse,
large B-cell lymphoma- Germinal center
B-cell type,HHV8+ DLBCL, NOS,Diffuse,
large B-cell lymphoma- Activated B-cell
type (non-GCB),EBV+ mucocutaneous
ulcer,Enteropathy-type T-cell
lymphoma,Extranodal NK / T-cell
lymphoma, nasal type,Duodenal-type
follicular lymphoma,Pediatric-type
follicular lymphoma,Follicular T-cell
lymphoma,Follicular (grade
unknown),Follicular, predominantly
large cell (Grade IIIA follicle center
Was any 17p abnormality detected? no,yes
Is the lymphoma histology reported
at transplant a transformation from a
different lymphoma histology? (Not
CLL)
No,Yes
Aggressive NK-cell leukemia,Anaplastic large-cell
lymphoma (ALCL), ALK negative,Anaplastic largecell lymphoma (ALCL), ALK
positive,Angioimmunoblastic T-cell
lymphoma,Adult T-cell lymphoma / leukemia
(HTLV1 associated),Breast implant-associated
anaplastic large-cell lymphoma,Burkitt-like
lymphoma with 11q aberration,Chronic
lymphoproliferative disorder of NK cells,Diffuse,
Large B-cell Lymphoma (cell of origin unknown),Bcell lymphoma, unclassifiable, with features
intermediate between DLBCL and classical
Hodgkin Lymphoma,DLBCL associated with
chronic inflammation,EBV+ DLBCL, NOS,Diffuse,
large B-cell lymphoma- Germinal center B-cell
type,HHV8+ DLBCL, NOS,Diffuse, large B-cell
lymphoma- Activated B-cell type (non-GCB),EBV+
mucocutaneous ulcer,Enteropathy-type T-cell
lymphoma,Extranodal NK / T-cell lymphoma, nasal
type,Duodenal-type follicular lymphoma,Pediatrictype follicular lymphoma,Follicular T-cell
lymphoma,Follicular (grade unknown),Follicular,
predominantly large cell (Grade IIIA follicle center
lymphoma),Follicular, predominantly large cell
(Grade IIIB follicle center lymphoma),Follicular,
predominantly large cell (Grade IIIA vs IIIB not
specified),Follicular, predominantly small cleaved
Specify the original lymphoma
cell (Grade I follicle center lymphoma),Follicular,
histology (prior to transformation)
mixed, small cleaved and large cell (Grade II
no
Specify other lymphoma histology:
open text
Specify other lymphoma histology:
no
Date of original lymphoma diagnosis:
(report the date of diagnosis of original
lymphoma subtype)
YYYY/MM/DD
open text
Date of original lymphoma diagnosis:
(report the date of diagnosis of
original lymphoma subtype)
YYYY/MM/DD
Was a PET (or PET/CT) scan
performed? (at last evaluation prior
to the start of the preparative
regimen / infusion)
no,yes
Was the PET (or PET/CT) scan
positive for lymphoma involvement
at any disease site?
no,yes
yes
no
yes
no
Was a PET (or PET/CT) scan performed? (at
last evaluation prior to the start of the
preparative regimen / infusion)
no,yes
Was the PET (or PET/CT) scan positive for
lymphoma involvement at any disease
site?
no,yes
yes
no
Date of PET scan
Known,Unknown
Date of PET scan
Known,Unknown
yes
no
Date of PET (or PET/CT) scan:
YYYY/MM/DD
Date of PET (or PET/CT) scan:
YYYY/MM/DD
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Page 38 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Current Information Collection Data
Element (if applicable)
Deauville (five-point) score of the PET (or
PET/CT) scan
Current Information Collection Data
Element Response Option(s)
Information Collection update:
no
Scale
no
What was the disease status?
Known,Unknown
1- no uptake or no residual uptake
2- slight uptake, but below blood pool
(mediastinum)
3- uptake above mediastinal, but below
or equal to uptake in the liver
4- uptake slightly to moderately higher
than liver
5- markedly increased uptake or any
new
CR1 -lesion
1st complete remission: no bone
marrow or extramedullary relapse prior
to transplant,CR2 - 2nd complete
remission,CR3+ - 3rd or subsequent
complete remission,PIF res - Primary
induction failure – resistant: NEVER in
COMPLETE remission but with stable or
progressive disease on treatment.,PIF
sen / PR1 - Primary induction failure –
sensitive: NEVER in COMPLETE remission
but with partial remission on
treatment.,PIF unk - Primary induction
failure – sensitivity unknown,REL1 res 1st relapse – resistant: stable or
progressive disease with treatment,REL1
sen - 1st relapse – sensitive: partial
remission (if complete remission was
achieved, classify as CR2),REL1 unk - 1st
relapse – sensitivity unknown,REL1 unt 1st relapse – untreated; includes either
bone marrow or extramedullary
relapse,REL2 res - 2nd relapse –
resistant: stable or progressive disease
with treatment,REL2 sen - 2nd relapse –
sensitive: partial remission (if complete
remission achieved, classify as
CR3+),REL2 unk - 2nd relapse –
sensitivity unknown,REL2 unt - 2nd
relapse – untreated: includes either
no
Total number of lines of therapy received
(between diagnosis and HCT / infusion)
1 line,2 lines,3+ lines
no
Date assessed:
no
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
YYYY/MM/DD
Amyloidosis,Monoclonal gammopathy
of renal significance (MGRS),Multiple
myeloma,Multiple myeloma-light chain
only,Multiple myeloma-nonsecretory,Osteosclerotic myeloma /
POEMS syndrome,Other plasma cell
disorder (PCD),Plasma cell leukemia
Specify the multiple myeloma/plasma cell (PCL),Smoldering myeloma,Solitary
disorder (PCD) classification
plasmacytoma
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Specify other plasma cell disorder:
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
open text
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
Deauville (five-point) score of the PET
(or PET/CT) scan
Known,Unknown
Scale
1- no uptake or no residual uptake
2- slight uptake, but below blood pool
(mediastinum)
3- uptake above mediastinal, but below or equal
to uptake in the liver
4- uptake slightly to moderately higher than liver
5markedly
increased
uptake or
new
lesionor
CR1
- 1st complete
remission:
noany
bone
marrow
extramedullary relapse prior to transplant,CR2 2nd complete remission,CR3+ - 3rd or subsequent
complete remission,PIF res - Primary induction
failure – resistant: NEVER in COMPLETE remission
but with stable or progressive disease on
treatment.,PIF sen / PR1 - Primary induction
failure – sensitive: NEVER in COMPLETE remission
but with partial remission on treatment.,PIF unk Primary induction failure – sensitivity
unknown,REL1 res - 1st relapse – resistant: stable
or progressive disease with treatment,REL1 sen 1st relapse – sensitive: partial remission (if
complete remission was achieved, classify as
CR2),REL1 unk - 1st relapse – sensitivity
unknown,REL1 unt - 1st relapse – untreated;
includes either bone marrow or extramedullary
relapse,REL2 res - 2nd relapse – resistant: stable or
progressive disease with treatment,REL2 sen - 2nd
relapse – sensitive: partial remission (if complete
remission achieved, classify as CR3+),REL2 unk 2nd relapse – sensitivity unknown,REL2 unt - 2nd
relapse – untreated: includes either bone marrow
or extramedullary relapse,REL3+ res - 3rd or
subsequent relapse – resistant: stable or
progressive disease with treatment,REL3+ sen 3rd or subsequent relapse – sensitive: partial
remission (if complete remission achieved, classify
as CR3+),REL3+ unk - 3rd relapse or greater –
What was the disease status?
Total number of lines of therapy
received (between diagnosis and HCT
/ infusion)
1 line,2 lines,3+ lines
Date assessed:
Specify other plasma cell disorder:
YYYY/MM/DD
Amyloidosis,Monoclonal gammopathy of renal
significance (MGRS),Multiple myeloma,Multiple
myeloma-light chain only,Multiple myeloma-nonsecretory,Osteosclerotic myeloma / POEMS
Specify the multiple
syndrome,Other plasma cell disorder (PCD),Plasma
myeloma/plasma cell disorder (PCD) cell leukemia (PCL),Smoldering myeloma,Solitary
classification
plasmacytoma
open text
Page 39 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
IgA (heavy chain only),IgA kappa,IgA lambda,IgD
(heavy chain only),IgD kappa,IgD lambda,IgE
(heavy chain only),IgE kappa,IgE lambda,IgG
(heavy chain only),IgG kappa,IgG lambda,IgM
Specify heavy and/or light chain type (heavy chain only),IgM kappa,IgM lambda,Kappa
(check all that apply)
(light chain only),Lambda (light chain only)
Specify Amyloidosis classification
AH amyloidosis,AHL amyloidosis,AL amyloidosis
Select monoclonal gammopathy of
renal significance (MGRS)
classification
C3 glomerulopathy with monoclonal
gammopathy,Crystal-storing
histiocytosis,Immunotactoid glomerulopathy
(ITGN)/ Glomerulonephritis with organized
monoclonal microtubular immunoglobulin
deposits (GOMMID),Light chain fanconi
syndrome,Monoclonal immunoglobulin deposition
disease (MIDD),Non-amyloid fibrillary
glomerulonephritis,Proliferative
glomerulonephritis with monoclonal
immunoglobulin G deposits (PGNMID),Proximal
tubulopathy without crystals,Type 1
cryoglobulinemic glomerulonephritis,Unknown
Select monoclonal immunoglobulin
deposition disease (MIDD) subtype
Heavy chain deposition disease (HCDD),Light chain
deposition disease (LCDD),Light and heavy chain
deposition disease (LHCDD)
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Specify heavy and/or light chain type
(check all that apply)
IgA (heavy chain only),IgA kappa,IgA
lambda,IgD (heavy chain only),IgD
kappa,IgD lambda,IgE (heavy chain
only),IgE kappa,IgE lambda,IgG (heavy
chain only),IgG kappa,IgG lambda,IgM
(heavy chain only),IgM kappa,IgM
lambda,Kappa (light chain only),Lambda
(light chain only)
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Specify Amyloidosis classification
AH amyloidosis,AHL amyloidosis,AL
amyloidosis
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Select monoclonal gammopathy of renal
significance (MGRS) classification
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Select monoclonal immunoglobulin
deposition disease (MIDD) subtype
C3 glomerulopathy with monoclonal
gammopathy,Crystal-storing
histiocytosis,Immunotactoid
glomerulopathy (ITGN)/
Glomerulonephritis with organized
monoclonal microtubular
immunoglobulin deposits
(GOMMID),Light chain fanconi
syndrome,Monoclonal immunoglobulin
deposition disease (MIDD),Non-amyloid
fibrillary glomerulonephritis,Proliferative
glomerulonephritis with monoclonal
immunoglobulin G deposits
(PGNMID),Proximal tubulopathy without
crystals,Type 1 cryoglobulinemic
glomerulonephritis,Unknown
Heavy chain deposition disease
(HCDD),Light chain deposition disease
(LCDD),Light and heavy chain deposition
disease (LHCDD)
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Was documentation submitted to the
CIBMTR? (e.g. pathology report)
No,Yes
Was documentation submitted to
the CIBMTR? (e.g. pathology report) No,Yes
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Solitary plasmacytoma was
Bone derived,Extramedullary
Solitary plasmacytoma was
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
What was the Durie-Salmon staging? (at
diagnosis)
no
What was the Durie-Salmon sub
classification? (at diagnosis)
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Stage I (All of the following: Hgb >
10g/dL; serum calcium normal or <10.5
mg/dL; bone x-ray normal bone
structure (scale 0), or solitary bone
plasmacytoma only; low M-component
production rates IgG < 5g/dL, IgA <
3g/dL; urine light chain M-component
on electrophoresis <4g/24h) – ,Stage II
(Fitting neither Stage I or Stage III) ,Stage
III (One of more of the following: Hgb <
8.5 g/dL; serum calcium > 12 mg/dL;
advanced lytic bone lesions (scale 3);
high M-component production rates IgG
>7g/dL, IgA > 5g/dL; Bence Jones protein
>12g/24h) ,Unknown
A - relatively normal renal function
(serum creatinine < 2.0 mg/dL,B abnormal renal function (serum
creatinine ≥ 2.0 mg/dL)
Rationale for Information Collection Update
Bone derived,Extramedullary
Stage I (All of the following: Hgb > 10g/dL; serum
calcium normal or <10.5 mg/dL; bone x-ray normal
bone structure (scale 0), or solitary bone
plasmacytoma only; low M-component
production rates IgG < 5g/dL, IgA < 3g/dL; urine
light chain M-component on electrophoresis
<4g/24h) – ,Stage II (Fitting neither Stage I or
Stage III) ,Stage III (One of more of the following:
Hgb < 8.5 g/dL; serum calcium > 12 mg/dL;
advanced lytic bone lesions (scale 3); high MWhat was the Durie-Salmon staging? component production rates IgG >7g/dL, IgA >
(at diagnosis)
5g/dL; Bence Jones protein >12g/24h) ,Unknown
What was the Durie-Salmon sub
classification? (at diagnosis)
A - relatively normal renal function (serum
creatinine < 2.0 mg/dL,B - abnormal renal function
(serum creatinine ≥ 2.0 mg/dL)
Page 40 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Did the recipient have a preceding or
concurrent plasma cell disorder?
No,Yes
Did the recipient have a preceding or
concurrent plasma cell disorder?
No,Yes
Specify preceding / concurrent
disorder
Amyloidosis,Monoclonal gammopathy of renal
significance,Monoclonal gammopathy of unknown
significance,Multiple myeloma,Multiple myeloma light chain only,Multiple myeloma - nonsecretory,Osteosclerotic myeloma / POEMS
syndrome,Other disease,Plasma cell
leukemia,Smoldering myeloma,Solitary
plasmacytoma
Specify other preceding/concurrent
disorder:
open text
yes
yes
Specify preceding / concurrent disorder
Amyloidosis,Monoclonal gammopathy
of renal significance,Monoclonal
gammopathy of unknown
significance,Multiple myeloma,Multiple
myeloma - light chain only,Multiple
myeloma - non-secretory,Osteosclerotic
myeloma / POEMS syndrome,Other
disease,Plasma cell leukemia,Smoldering
myeloma,Solitary plasmacytoma
yes
yes
Specify other preceding/concurrent
disorder:
open text
Disease
Classification
Preceding or
Concurrent
Plasma Cell
Disorder
Preceding or
Concurrent
Plasma Cell
Disorder
Preceding or
Concurrent
Plasma Cell
Disorder
yes
yes
Date of diagnosis of preceding / concurrent
disorder:
YYYY/MM/DD
Date of diagnosis of preceding /
concurrent disorder:
YYYY/MM/DD
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Serum beta2 - microglobulin
Known,Unknown
Serum beta2 - microglobulin
Known,Unknown
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Serum beta2-microglobulin:
: ___ ___ ___ ● ___ ___ ___
: ___ ___ ___ ● ___ ___ ___
: ___ ___ ___ ● ___ ___ ___
Serum beta2-microglobulin:
: ___ ___ ___ ● ___ ___ ___
: ___ ___ ___ ● ___ ___ ___
: ___ ___ ___ ● ___ ___ ___
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Serum albumin
Known,Unknown
Serum albumin
Known,Unknown
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Serum albumin:
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
I.S.S Stage
Known,Unknown
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
I.S.S Stage
1 (Serum β2-microglobulin < 3.5 mg/L,
Serum albumin ≥ 3.5 g/dL), 2(Not fitting
stage 1 or 3) ,3 (Serum β2-microglobulin
≥ 5.5 mg/L; Serum albumin —)
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
R-I.S.S Stage
Disease
Classification
Disease
Classification
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
μg/dL
mg/L
nmol/L
: ___ ___ ● ___ g/dL
: ___ ___ ● ___ g/L
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
R-I.S.S Stage
Rationale for Information Collection Update
μg/dL
mg/L
nmol/L
: ___ ___ ● ___ g/dL
: ___ ___ ● ___ g/L
Serum albumin:
Known,Unknown
1 (ISS stage I and no high-risk
cytogenetic abnormalities by FISH
[deletion 17p / 17p-, t(4;14), t(14;16)]
and normal LDH levels),2(Not R-ISS stage
I or III),3(ISS stage III and either high-risk
cytogenetic abnormalities by FISH
[deletion 17p / 17p-, t(4;14), t(14;16)] or
high LDH levels)
I.S.S Stage
Known,Unknown
I.S.S Stage
1 (Serum β2-microglobulin < 3.5 mg/L, Serum
albumin ≥ 3.5 g/dL), 2(Not fitting stage 1 or 3) ,3
(Serum β2-microglobulin ≥ 5.5 mg/L; Serum
albumin —)
R-I.S.S Stage
Known,Unknown
R-I.S.S Stage
1 (ISS stage I and no high-risk cytogenetic
abnormalities by FISH [deletion 17p / 17p-, t(4;14),
t(14;16)] and normal LDH levels),2(Not R-ISS stage
I or III),3(ISS stage III and either high-risk
cytogenetic abnormalities by FISH [deletion 17p /
17p-, t(4;14), t(14;16)] or high LDH levels)
Page 41 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
Disease
Classification
no
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
Plasma cells in blood by flow cytometry
Known,Unknown
Plasma cells in peripheral blood by
flow cytometry
Capture data accurately
Plasma cells in blood by flow cytometry
___ ___• ___ ___ %
Plasma cells in blood by morphologic
assessment
Known,Unknown
Plasma cells in blood by morphologic
assessment
___ ___• ___ ___ %
Change/Clarification of Information Requested
Plasma cells in blood by flow
cytometry
Change/Clarification of Information Requested
Plasma cells in peripheral blood by
morphologic assessment
Known,Unknown
___ ___• ___ ___ %
Known,Unknown
Capture data accurately
Plasma cells in blood by morphologic
___ ___• ___ ___ %
assessment
no
no
Plasma cells in blood by morphologic
assessment
___ ___ ___ ___ ___ • ___ ___ □ x
109/L (x 103/mm3)
___ ___ ___ ___ ___ • ___ ___ □ x
106/L
___ ___ ___ ___ ___ • ___ ___ □ x 109/L (x
Plasma cells in blood by morphologic 103/mm3)
assessment
___ ___ ___ ___ ___ • ___ ___ □ x 106/L
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
LDH
Known,Unknown
LDH
Known,Unknown
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
LDH
___ ___ ___ ___ ___ ● ___ ___ o U/L
___ ___ ___ ___ ___ ● ___ ___ o μkat/L
LDH
___ ___ ___ ___ ___ ● ___ ___ o U/L
___ ___ ___ ___ ___ ● ___ ___ o μkat/L
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Upper limit of normal for LDH:
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Were cytogenetics tested (karyotyping or
FISH)? (at diagnosis)
no,Unknown,yes
Were cytogenetics tested
(karyotyping or FISH)? (at diagnosis) no,Unknown,yes
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Were cytogenetics tested via FISH?
No,Yes
Were cytogenetics tested via FISH?
No,Yes
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Results of tests
Abnormalities identified,No
abnormalities
Results of tests
Abnormalities identified,No abnormalities
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
Any abnormality at 1p,Any abnormality at
1q,del(13q) / 13q-,del(17p) / 17p-,Hyperdiploid (>
50),Hypodiploid (< 46),-13,-17,MYC
rearrangement,Other
Specify abnormalities (check all that abnormality,t(11;14),t(14;16),t(14;20),t(4;14),t(6;1
apply)
4),+11,+15,+19,+3,+5,+7,+9
___ ___ ___ ___ ___ • ___ ___
___ ___ ___ ___ ___ • ___ ___
Upper limit of normal for LDH:
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Any abnormality at 1p,Any abnormality
at 1q,del(13q) / 13q-,del(17p) / 17p,Hyperdiploid (> 50),Hypodiploid (< 46),13,-17,MYC rearrangement,Other
abnormality,t(11;14),t(14;16),t(14;20),t(
Specify abnormalities (check all that apply) 4;14),t(6;14),+11,+15,+19,+3,+5,+7,+9
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Specify other abnormality:
open text
Specify other abnormality:
open text
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Was documentation submitted to the
CIBMTR? (e.g. FISH report)
No,Yes
Was documentation submitted to
the CIBMTR? (e.g. FISH report)
No,Yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Page 42 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Were cytogenetics tested via karyotyping? No,Yes
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Results of tests
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Any abnormality at 1p,Any abnormality at
1q,del(13q) / 13q-,del(17p) / 17p-,Hyperdiploid (>
50),Hypodiploid (< 46),-13,-17,MYC
rearrangement,Other
Specify abnormalities (check all that abnormality,t(11;14),t(14;16),t(14;20),t(4;14),t(6;1
apply)
4),+11,+15,+19,+3,+5,+7,+9
Specify other abnormality:
open text
Was documentation submitted to
the CIBMTR? (e.g. karyotyping
report)
No,Yes
What is the hematologic disease
status?
Complete remission (CR),Progressive disease
(PD),Partial remission (PR),Relapse from CR (Rel)
(untreated),Stringent complete remission
(sCR),Stable disease (SD),Unknown,Very good
partial remission (VGPR)
Date assessed:
YYYY/MM/DD
Date assessed:
Were cytogenetics tested via
karyotyping?
No,Yes
Abnormalities identified,No
abnormalities,No evaluable metaphases
Results of tests
Abnormalities identified,No abnormalities,No
evaluable metaphases
open text
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
open text
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Any abnormality at 1p,Any abnormality
at 1q,del(13q) / 13q-,del(17p) / 17p,Hyperdiploid (> 50),Hypodiploid (< 46),13,-17,MYC rearrangement,Other
abnormality,t(11;14),t(14;16),t(14;20),t(
Specify abnormalities (check all that apply) 4;14),t(6;14),+11,+15,+19,+3,+5,+7,+9
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Specify other abnormality:
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Was documentation submitted to the
CIBMTR? (e.g. karyotyping report)
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
What is the hematologic disease status?
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Date assessed:
open text
No,Yes
Complete remission (CR),Progressive
disease (PD),Partial remission
(PR),Relapse from CR (Rel)
(untreated),Stringent complete
remission (sCR),Stable disease
(SD),Unknown,Very good partial
remission (VGPR)
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
YYYY/MM/DD
Complete response (CR),No response
(NR) / stable disease (SD),Progressive
disease (PD),Partial response
(PR),Relapse from CR (Rel)
Specify amyloidosis hematologic response (untreated),Unknown,Very good partial
(for Amyloid patients only)
response (VGPR)
Disease
Classification
Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes
no
Date assessed:
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
YYYY/MM/DD
Rationale for Information Collection Update
Complete response (CR),No response (NR) / stable
disease (SD),Progressive disease (PD),Partial
response (PR),Relapse from CR (Rel)
Specify amyloidosis hematologic
(untreated),Unknown,Very good partial response
response (for Amyloid patients only) (VGPR)
YYYY/MM/DD
Page 43 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Breast cancer,Bone sarcoma (excluding Ewing
family tumors),Cervical,Central nervous system
tumor, including CNS PNET,Colorectal,Ovarian
(epithelial),Ewing family tumors, extraosseous
(including PNET),Ewing family tumors of bone
(including PNET),External
genitalia,Fibrosarcoma,Gastric,Germ cell tumor,
extragonadal,Hepatobiliary,Head /
neck,Hemangiosarcoma,Lung, not otherwise
specified,Leiomyosarcoma,Lymphangio
sarcoma,Liposarcoma,Medulloblastoma,Mediastin
al
neoplasm,Melanoma,Neuroblastoma,Neurogenic
sarcoma,Lung, non-small cell,Other solid
tumor,Prostate,Renal
cell,Retinoblastoma,Rhabdomyosarcoma,Lung,
small cell,Synovial sarcoma,Solid tumor, not
otherwise specified,Pancreatic,Soft tissue sarcoma
(excluding Ewing family
tumors),Testicular,Thymoma,Uterine,Vaginal,Wil
Specify the solid tumor classification m Tumor
Specify other solid tumor:
Solid Tumors
yes
no
Specify the solid tumor classification
Breast cancer,Bone sarcoma (excluding
Ewing family tumors),Cervical,Central
nervous system tumor, including CNS
PNET,Colorectal,Ovarian
(epithelial),Ewing family tumors,
extraosseous (including PNET),Ewing
family tumors of bone (including
PNET),External
genitalia,Fibrosarcoma,Gastric,Germ cell
tumor, extragonadal,Hepatobiliary,Head
/ neck,Hemangiosarcoma,Lung, not
otherwise
specified,Leiomyosarcoma,Lymphangio
sarcoma,Liposarcoma,Medulloblastoma,
Mediastinal
neoplasm,Melanoma,Neuroblastoma,Ne
urogenic sarcoma,Lung, non-small
cell,Other solid tumor,Prostate,Renal
cell,Retinoblastoma,Rhabdomyosarcom
a,Lung, small cell,Synovial sarcoma,Solid
tumor, not otherwise
specified,Pancreatic,Soft tissue sarcoma
(excluding Ewing family
tumors),Testicular,Thymoma,Uterine,Va
ginal,Wilm Tumor
Solid Tumors
yes
no
Specify other solid tumor:
open text
Acquired amegakaryocytosis (not
congenital),Acquired pure red cell
aplasia (not congenital),Acquired AA,
not otherwise specified,Other acquired
cytopenic syndrome,Acquried AA
secondary to chemotherapy,Acquired
Specify the aplastic anemia classification – AA, secondary to hepatitis,Acquired AA
If the recipient developed MDS or AML,
secondary to immunotherapy or
indicate MDS or AML as the primary
immune effector cell therapy,Acquired
disease.
AA, secondary to toxin / other drug
Acquired amegakaryocytosis (not
congenital),Acquired pure red cell aplasia (not
congenital),Acquired AA, not otherwise
specified,Other acquired cytopenic
syndrome,Acquried AA secondary to
chemotherapy,Acquired AA, secondary to
Specify the aplastic anemia
hepatitis,Acquired AA secondary to
classification – If the recipient
immunotherapy or immune effector cell
developed MDS or AML, indicate
therapy,Acquired AA, secondary to toxin / other
MDS or AML as the primary disease. drug
Specify severity
Specify other acquired cytopenic
syndrome:
Specify severity
Specify other acquired cytopenic
syndrome:
Aplastic Anemia
yes
no
Aplastic Anemia
yes
no
Aplastic Anemia
yes
no
yes
no
yes
no
Disease
Classification
Inherited Bone
Marrow Failure
Syndromes
Inherited Bone
Marrow Failure
Syndromes
Disease
Classification
Hemoglobinopathi
es
yes
Disease
Classification
Disease
Classification
Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes
Disease
Classification
Hemoglobinopathi
es
yes
Disease
Classification
Current Information Collection Data
Element (if applicable)
Not severe,Severe / very severe
no
open text
Dyskeratosis congenita,Fanconi
anemia,Severe congenital
Specify the inherited bone marrow failure neutropenia,Diamond-Blackfan
syndrome classification
anemia,Shwachman-Diamond
Did the recipient receive gene therapy to
treat the inherited bone marrow failure
syndrome?
No,Yes
Other hemoglobinopathy,Sickle cell
Specify the hemoglobinopathy
disease,Transfusion dependent
classification
thalassemia
Transfusion dependent beta
thalassemia,Other transfusion
Specify transfusion dependent thalassemia dependent thalassemia
no
Specify other hemoglobinopathy:
open text
no
Did the recipient receive gene therapy to
treat the hemoglobinopathy?
No,Yes
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Change/Clarification of Response Options
Deletion of Information Requested
Deletion of Information Requested
Specify the inherited bone marrow
failure syndrome classification
Did the recipient receive gene
therapy to treat the inherited bone
marrow failure syndrome?
Rationale for Information Collection Update
open text
Not severe,Severe / very severe
open text
Dyskeratosis congenita,Fanconi anemia,Severe
congenital neutropenia,Diamond-Blackfan
anemia,Shwachman-Diamond, Other inherited
bone failure syndromes
Be consistent with current clinical landscape, improve
transplant outcome data
No,Yes
Reduce redundancy in data capture
Specify the hemoglobinopathy
classification
Other hemoglobinopathy,Sickle cell
disease,Transfusion dependent thalassemia
Specify transfusion dependent
thalassemia
Transfusion dependent beta thalassemia,Other
transfusion dependent thalassemia
Specify other hemoglobinopathy:
Did the recipient receive gene
therapy to treat the
hemoglobinopathy?
open text
No,Yes
Reduce redundancy in data capture
Page 44 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
yes
no
Was tricuspid regurgitant jet velocity
(TRJV) measured by echocardiography?
No,Unknown,Yes
Was tricuspid regurgitant jet velocity
(TRJV) measured by
echocardiography?
No,Unknown,Yes
yes
no
TRJV measurement
Known,Unknown
TRJV measurement
yes
no
yes
no
TRJV measurement:
Was liver iron content (LIC) tested within 6
months prior to infusion?
No,Yes
Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes
__ __ ● ___ m/sec
no
Liver iron content:
no
Method used to estimate LIC?
___ ___ ___ ● ___mg Fe/g liver dry
weight
___ ___ ___ ● ___g Fe/kg liver dry
weight
___ ___ ___ ● ___µmol Fe / g liver dry
weight
FerriScan,Liver Biopsy,Other,SQUID
MRI,T2 MRI
no
Is the recipient red blood cell transfusion
dependent? (requiring transfusion to
maintain HGB 9-10 g/dL)
No,Yes
Known,Unknown
__ __ ● ___ m/sec
No,Yes
___ ___ ___ ● ___mg Fe/g liver dry weight
___ ___ ___ ● ___g Fe/kg liver dry weight
___ ___ ___ ● ___µmol Fe / g liver dry weight
Liver iron content:
Method used to estimate LIC?
Is the recipient red blood cell
transfusion dependent? (requiring
transfusion to maintain HGB 9-10
g/dL)
Year of first transfusion: (since
diagnosis):
Was iron chelation therapy given at
any time since diagnosis?
FerriScan,Liver Biopsy,Other,SQUID MRI,T2 MRI
No,Yes
no
Year of first transfusion: (since diagnosis):
Was iron chelation therapy given at any
time since diagnosis?
yes
no
Did iron chelation therapy meet the
following criteria: initiated within 18
months of the first transfusion and
administered for at least 5 days / week
(either oral or parenteral iron chelation
medication)?
yes
no
Specify reason criteria not met
No, iron chelation therapy given, but not
meeting criteria,Iron chelation therapy
given, but details of administration
unknown,Yes, iron chelation therapy
given as specified
Non-adherence,Other,Toxicity due to
iron chelation therapy
yes
no
Specify other reason criteria not met:
open text
Specify other reason criteria not met: open text
yes
no
Year iron chelation therapy started
Known,Unknown
Year iron chelation therapy started
Known,Unknown
YYYY
YYYY
no,yes
Year started:
Did the recipient have
hepatomegaly? (≥ 2 cm below costal
margin)
Liver size as measured below the
costal margin at most recent
evaluation:
Was a liver biopsy performed at any
time since diagnosis?
no
YYYY
TRJV measurement:
Was liver iron content (LIC) tested
within 6 months prior to infusion?
No,Unknown,Yes
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
yes
no
Year started:
Disease
Classification
Hemoglobinopathi
es
yes
no
Did the recipient have hepatomegaly? (≥ 2
cm below costal margin)
no,Unknown,yes
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Did iron chelation therapy meet the
following criteria: initiated within 18
months of the first transfusion and
administered for at least 5 days /
week (either oral or parenteral iron
chelation medication)?
Specify reason criteria not met
YYYY
No,Unknown,Yes
No, iron chelation therapy given, but not meeting
criteria,Iron chelation therapy given, but details of
administration unknown,Yes, iron chelation
therapy given as specified
Non-adherence,Other,Toxicity due to iron
chelation therapy
no,Unknown,yes
yes
no
yes
no
Liver size as measured below the costal
margin at most recent evaluation:
Was a liver biopsy performed at any time
since diagnosis?
yes
no
Date functional status assessed
Known,Unknown
Date functional status assessed
Known,Unknown
yes
no
Date assessed:
YYYY/MM/DD
Date assessed:
YYYY/MM/DD
yes
no
Date estimated
checked
Date estimated
checked
yes
no
Was there evidence of liver cirrhosis?
No,Unknown,Yes
Was there evidence of liver cirrhosis? No,Unknown,Yes
yes
no
Was there evidence of liver fibrosis?
No,Unknown,Yes
Was there evidence of liver fibrosis? No,Unknown,Yes
yes
no
Type of fibrosis
Bridging,Other,Periportal,Unknown
yes
no
Was there evidence of chronic hepatitis?
No,Unknown,Yes
Type of fibrosis
Was there evidence of chronic
hepatitis?
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
__ __ cm
Rationale for Information Collection Update
__ __ cm
no,yes
Bridging,Other,Periportal,Unknown
No,Unknown,Yes
Page 45 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Disease
Classification
Hemoglobinopathi
es
yes
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disorders of the
Immune System
Disorders of the
Immune System
Disorders of the
Immune System
Disorders of the
Immune System
Disease
Classification
Disorders of the
Immune System
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
No,Yes
Was documentation submitted to
the CIBMTR? (e.g. liver biopsy)
no
Was documentation submitted to the
CIBMTR? (e.g. liver biopsy)
yes
no
Is there evidence of abnormal cardiac iron
deposition based on MRI of the heart at
time of infusion?
No,Yes
yes
no
Did the recipient have a splenectomy?
no,Unknown,yes
yes
no
Serum iron
no
Serum iron:
Known,Unknown
: ___ ___ ___● ___ ___ µg / dL
: ___ ___ ___● ___ ___µmol / L
Serum iron
yes
yes
no
Total iron binding capacity (TIBC)
Total iron binding capacity (TIBC)
yes
no
TIBC:
Known,Unknown
: ___ ___ ___● ___ ___ µg / dL
: ___ ___ ___● ___ ___µmol / L
yes
no
Total serum bilirubin
no
yes
no
Total serum bilirubin:
Upper limit of normal for total serum
bilirubin:
Known,Unknown
: ___ ___ ___● ___ ___ mg/dL
: ___ ___ ___● ___ ___µmol / L
Total serum bilirubin
yes
__ __ __ ● __
No,Yes
Is there evidence of abnormal cardiac
iron deposition based on MRI of the
heart at time of infusion?
No,Yes
Did the recipient have a
splenectomy?
no,Unknown,yes
Serum iron:
TIBC:
Known,Unknown
: ___ ___ ___● ___ ___ µg / dL
: ___ ___ ___● ___ ___µmol / L
Known,Unknown
: ___ ___ ___● ___ ___ µg / dL
: ___ ___ ___● ___ ___µmol / L
Known,Unknown
: ___ ___ ___● ___ ___ mg/dL
Total serum bilirubin:
: ___ ___ ___● ___ ___µmol / L
Upper limit of normal for total serum
__ __ __ ● __
bilirubin:
yes
no
Specify disorder of immune system
classification
Ataxia telangiectasia,Bare lymphocyte
syndrome,Cartilage hair
hypoplasia,CD40 ligand
deficiency,Chronic granulomatous
disease,DiGeorge anomaly,Griscelli
syndrome type 2,HIV
infection,Hermansky-Pudlak syndrome
type 2,Leukocyte adhesion deficiencies,
including GP180, CD-18, LFA and WBC
adhesion deficiencies,Neutrophil actin
deficiency,Chediak-Higashi
syndrome,Other
immunodeficiencies,Omenn
syndrome,Other pigmentary dilution
disorder,Other SCID,Reticular
dysgenesis,Adenosine deaminase (ADA)
deficiency / severe combined
immunodeficiency (SCID),SCID, not
otherwise specified,Absence of T and B
cells SCID,Absence of T, normal B cell
SCID,Immune deficiency, not otherwise
specified,Common variable
immunodeficiency,Wiskott-Aldrich
syndrome,X-linked lymphoproliferative
syndrome
yes
no
Specify other SCID:
open text
Specify other SCID:
open text
yes
no
Specify other immunodeficiency:
open text
open text
yes
no
yes
no
Specify other pigmentary dilution disorder: open text
Did the recipient have an active or recent
infection with a viral pathogen within 60
days of HCT?
No,Yes
Specify other immunodeficiency:
Specify other pigmentary dilution
disorder:
Did the recipient have an active or
recent infection with a viral
pathogen within 60 days of HCT?
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
Specify disorder of immune system
classification
Ataxia telangiectasia,Bare lymphocyte
syndrome,Cartilage hair hypoplasia,CD40 ligand
deficiency,Chronic granulomatous
disease,DiGeorge anomaly,Griscelli syndrome type
2,HIV infection,Hermansky-Pudlak syndrome type
2,Leukocyte adhesion deficiencies, including
GP180, CD-18, LFA and WBC adhesion
deficiencies,Neutrophil actin deficiency,ChediakHigashi syndrome,Other
immunodeficiencies,Omenn syndrome,Other
pigmentary dilution disorder,Other SCID,Reticular
dysgenesis,Adenosine deaminase (ADA) deficiency
/ severe combined immunodeficiency (SCID),SCID,
not otherwise specified,Absence of T and B cells
SCID,Absence of T, normal B cell SCID,Immune
deficiency, not otherwise specified,Common
variable immunodeficiency,Wiskott-Aldrich
syndrome,X-linked lymphoproliferative syndrome
open text
No,Yes
Page 46 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disorders of the
Immune System
Disorders of the
Immune System
Disease
Classification
Disorders of the
Immune System
Disease
Classification
Disease
Classification
Inherited
Abnormalities of
Platelets
Inherited
Abnormalities of
Platelets
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Adenovirus,BK Virus,Chikaugunya
Virus,Cytomegalovirus
(CMV),Coronavirus,Dengue Virus,EpsteinBarr Virus (EBV),Enterovirus D68 (EVD68),Enterovirus (ECHO,
Coxsackie),Enterovirus, NOS,Enterovirus
(polio),Hepatitis A Virus,Hepatitis B
Virus,Hepatitis C Virus,Hepatitis
E,Human herpesvirus 6 (HHV-6),Human
Immunodeficiency Virus 1 or 2,Human
metapneumovirus,Human
Papillomavirus (HPV),Herpes Simplex
Virus (HSV),Human T-lymphotropic Virus
1 or 2,Influenza A Virus,Influenza B
Virus,Influenza, NOS,JC Virus
(Progressive Multifocal
Leukoencephalopathy (PML)),Measles
Virus (Rubeola),Mumps
Virus,Norovirus,Human Parainfluenza
Virus (all species),Rhinovirus (all
species),Rotavirus (all
species),Respiratory Syncytial Virus
(RSV),Rubella Virus,Varicella Virus,West
Nile Virus (WNV)
yes
no
Specify viral pathogen (check all that
apply)
Has the recipient ever been infected with
PCP / PJP?
No,Yes
Does the recipient have GVHD due to
maternal cell engraftment pre-HCT? (SCID
only)
No,Yes
Congenital amegakaryocytosis /
congenital thrombocytopenia
(501),Glanzmann thrombasthenia
Specify inherited abnormalities of platelets (502),Other inherited platelet
classification
abnormality (509)
yes
no
Specify other inherited platelet
abnormality:
yes
no
yes
no
yes
no
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
open text
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
Adenovirus,BK Virus,Chikaugunya
Virus,Cytomegalovirus (CMV),Coronavirus,Dengue
Virus,Epstein-Barr Virus (EBV),Enterovirus D68 (EVD68),Enterovirus (ECHO, Coxsackie),Enterovirus,
NOS,Enterovirus (polio),Hepatitis A Virus,Hepatitis
B Virus,Hepatitis C Virus,Hepatitis E,Human
herpesvirus 6 (HHV-6),Human Immunodeficiency
Virus 1 or 2,Human metapneumovirus,Human
Papillomavirus (HPV),Herpes Simplex Virus
(HSV),Human T-lymphotropic Virus 1 or
2,Influenza A Virus,Influenza B Virus,Influenza,
NOS,JC Virus (Progressive Multifocal
Leukoencephalopathy (PML)),Measles Virus
(Rubeola),Mumps Virus,Norovirus,Human
Parainfluenza Virus (all species),Rhinovirus (all
species),Rotavirus (all species),Respiratory
Specify viral pathogen (check all that Syncytial Virus (RSV),Rubella Virus,Varicella
apply)
Virus,West Nile Virus (WNV)
Has the recipient ever been infected
with PCP / PJP?
No,Yes
Does the recipient have GVHD due to
maternal cell engraftment pre-HCT?
(SCID only)
No,Yes
Specify inherited abnormalities of
platelets classification
Congenital amegakaryocytosis / congenital
thrombocytopenia (501),Glanzmann
thrombasthenia (502),Other inherited platelet
abnormality (509)
Specify other inherited platelet
abnormality:
open text
Page 47 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Inherited
Disorders of
Metabolism
Inherited
Disorders of
Metabolism
Inherited
Disorders of
Metabolism
Disease
Classification
Disease
Classification
Histiocytic
Disorders
Histiocytic
Disorders
Disease
Classification
Histiocytic
Disorders
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Adrenoleukodystrophy (ALD)
(543),Aspartyl glucosaminidase (561),ßglucuronidase deficiency (VII)
(537),Fucosidosis (562),Gaucher disease
(541),Glucose storage disease
(548),Hunter syndrome (II) (533),Hurler
syndrome (IH) (531),I-cell disease
(546),Krabbe disease (globoid
leukodystrophy) (544),Lesch-Nyhan
(HGPRT deficiency) (522),Mannosidosis
(563),Maroteaux-Lamy (VI)
(536),Metachromatic leukodystrophy
(MLD) (542),Mucolipidoses, not
otherwise specified (540),Morquio (IV)
(535),Mucopolysaccharidosis (V)
(538),Mucopolysaccharidosis, not
otherwise specified (530),Niemann-Pick
disease (545),Neuronal ceroid
lipofuscinosis (Batten disease)
(523),Other inherited metabolic disorder
(529),Osteopetrosis (malignant infantile
osteopetrosis) (521),Polysaccharide
hydrolase abnormality, not otherwise
specified (560),Sanfilippo (III)
(534),Scheie syndrome (IS)
(532),Inherited metabolic disorder, not
otherwise specified (520),Wolman
disease (547)
Change/Clarification of Response Options
Specify inherited disorders of
metabolism classification
Specify other inherited metabolic disorder: open text
Specify other inherited metabolic
disorder:
open text
Loes composite score
Loes composite score
__ __ Adrenoleukodystrophy (ALD) only
Specify histiocytic disorder
classification
Histiocytic disorder, not otherwise specified
(570),Langerhans cell histiocytosis (histiocytosis-X)
(572),Hemophagocytic lymphohistiocytosis (HLH)
(571),Hemophagocytosis (reactive or viral
associated) (573),Malignant histiocytosis
(574),Other histiocytic disorder (579)
Specify other histiocytic disorder:
open text
Did the recipient have an active or
recent infection with a viral
pathogen within 60 days of HCT?
Hemophagocytic lymphohistiocytosis
(HLH) only
No,Yes
no
Specify inherited disorders of metabolism
classification
yes
no
yes
no
yes
no
Specify histiocytic disorder classification
__ __ Adrenoleukodystrophy (ALD) only
Histiocytic disorder, not otherwise
specified (570),Langerhans cell
histiocytosis (histiocytosis-X)
(572),Hemophagocytic
lymphohistiocytosis (HLH)
(571),Hemophagocytosis (reactive or
viral associated) (573),Malignant
histiocytosis (574),Other histiocytic
disorder (579)
yes
no
Specify other histiocytic disorder:
open text
no
Did the recipient have an active or recent
infection with a viral pathogen within 60
days of HCT? Hemophagocytic
lymphohistiocytosis (HLH) only
No,Yes
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Rationale for Information Collection Update
Hereditary diffuse leukoencephalopathy with
spheroids, Adrenoleukodystrophy (ALD)
(543),Aspartyl glucosaminidase (561),ßglucuronidase deficiency (VII) (537),Fucosidosis
(562),Gaucher disease (541),Glucose storage
disease (548),Hunter syndrome (II) (533),Hurler
syndrome (IH) (531),I-cell disease (546),Krabbe
disease (globoid leukodystrophy) (544),LeschNyhan (HGPRT deficiency) (522),Mannosidosis
(563),Maroteaux-Lamy (VI) (536),Metachromatic
leukodystrophy (MLD) (542),Mucolipidoses, not
otherwise specified (540),Morquio (IV)
(535),Mucopolysaccharidosis (V)
(538),Mucopolysaccharidosis, not otherwise
specified (530),Niemann-Pick disease
(545),Neuronal ceroid lipofuscinosis (Batten
disease) (523),Other inherited metabolic disorder
(529),Osteopetrosis (malignant infantile
osteopetrosis) (521),Polysaccharide hydrolase
abnormality, not otherwise specified
(560),Sanfilippo (III) (534),Scheie syndrome (IS)
(532),Inherited metabolic disorder, not otherwise Be consistent with current clinical landscape, improve
specified (520),Wolman disease (547)
transplant outcome data
yes
yes
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Page 48 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Histiocytic
Disorders
Histiocytic
Disorders
Autoimmune
Diseases
Autoimmune
Diseases
Autoimmune
Diseases
Autoimmune
Diseases
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Adenovirus,BK Virus,Chikaugunya
Virus,Cytomegalovirus
(CMV),Coronavirus,Dengue Virus,EpsteinBarr Virus (EBV),Enterovirus D68 (EVD68),Enterovirus (ECHO,
Coxsackie),Enterovirus, NOS,Enterovirus
(polio),Hepatitis A Virus,Hepatitis B
Virus,Hepatitis C Virus,Hepatitis
E,Human herpesvirus 6 (HHV-6),Human
Immunodeficiency Virus 1 or 2,Human
metapneumovirus,Human
Papillomavirus (HPV),Herpes Simplex
Virus (HSV),Human T-lymphotropic Virus
1 or 2,Influenza A Virus,Influenza B
Virus,Influenza, NOS,JC Virus
(Progressive Multifocal
Leukoencephalopathy (PML)),Measles
Virus (Rubeola),Mumps
Virus,Norovirus,Human Parainfluenza
Virus (all species),Rhinovirus (all
species),Rotavirus (all
species),Respiratory Syncytial Virus
(RSV),Rubella Virus,Varicella Virus,West
Nile Virus (WNV)
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Adenovirus,BK Virus,Chikaugunya
Virus,Cytomegalovirus (CMV),Coronavirus,Dengue
Virus,Epstein-Barr Virus (EBV),Enterovirus D68 (EVD68),Enterovirus (ECHO, Coxsackie),Enterovirus,
NOS,Enterovirus (polio),Hepatitis A Virus,Hepatitis
B Virus,Hepatitis C Virus,Hepatitis E,Human
herpesvirus 6 (HHV-6),Human Immunodeficiency
Virus 1 or 2,Human metapneumovirus,Human
Papillomavirus (HPV),Herpes Simplex Virus
(HSV),Human T-lymphotropic Virus 1 or
2,Influenza A Virus,Influenza B Virus,Influenza,
NOS,JC Virus (Progressive Multifocal
Leukoencephalopathy (PML)),Measles Virus
(Rubeola),Mumps Virus,Norovirus,Human
Parainfluenza Virus (all species),Rhinovirus (all
species),Rotavirus (all species),Respiratory
Specify viral pathogen (check all that Syncytial Virus (RSV),Rubella Virus,Varicella
apply)
Virus,West Nile Virus (WNV)
Has the recipient ever been infected
with PCP / PJP?
No,Yes
yes
no
yes
no
Specify viral pathogen (check all that
apply)
Has the recipient ever been infected with
PCP / PJP?
yes
no
Antiphospholipid syndrome,Behcet
syndrome,Churg-Strauss,Classical
polyarteritis nodosa,Crohn's
disease,Diabetes mellitus type I,Evan
syndrome,Giant cell arteritis,Hemolytic
anemia,Idiopathic thrombocytopenic
purpura (ITP),Juvenile idiopathic arthritis
(JIA): oligoarticular,Juvenile idiopathic
arthritis (JIA): other,Juvenile idiopathic
arthritis (JIA): polyarticular,Juvenile
idiopathic arthritis (JIA): systemic (Stills
disease),Microscopic polyarteritis
nodosa,Multiple sclerosis,Myasthenia
gravis,Other autoimmune
disorder,Overlap necrotizing
arteritis,Other arthritis,Other
autoimmune bowel disorder,Other
autoimmune cytopenia,Other
autoimmune neurological
disorder,Other connective tissue
disease,Other vasculitis,Psoriatic arthritis
/ psoriasis,Polymyositis /
dermatomyositis,Rheumatoid
arthritis,Sjogren syndrome,Systemic
lupus erythematosis (SLE),Systemic
sclerosis,Takayasu,Ulcerative
Specify autoimmune disease classification colitis,Wegener granulomatosis
yes
no
Specify other autoimmune cytopenia:
yes
no
Specify other autoimmune bowel disorder: open text
Specify autoimmune disease
classification
Specify other autoimmune
cytopenia:
Specify other autoimmune bowel
disorder:
yes
no
Specify other autoimmune disease:
Specify other autoimmune disease:
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
No,Yes
open text
open text
Rationale for Information Collection Update
Antiphospholipid syndrome,Behcet
syndrome,Churg-Strauss,Classical polyarteritis
nodosa,Crohn's disease,Diabetes mellitus type
I,Evan syndrome,Giant cell arteritis,Hemolytic
anemia,Idiopathic thrombocytopenic purpura
(ITP),Juvenile idiopathic arthritis (JIA):
oligoarticular,Juvenile idiopathic arthritis (JIA):
other,Juvenile idiopathic arthritis (JIA):
polyarticular,Juvenile idiopathic arthritis (JIA):
systemic (Stills disease),Microscopic polyarteritis
nodosa,Multiple sclerosis,Myasthenia gravis,Other
autoimmune disorder,Overlap necrotizing
arteritis,Other arthritis,Other autoimmune bowel
disorder,Other autoimmune cytopenia,Other
autoimmune neurological disorder,Other
connective tissue disease,Other vasculitis,Psoriatic
arthritis / psoriasis,Polymyositis /
dermatomyositis,Rheumatoid arthritis,Sjogren
syndrome,Systemic lupus erythematosis
(SLE),Systemic sclerosis,Takayasu,Ulcerative
colitis,Wegener granulomatosis
open text
open text
open text
Page 49 of 50
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Tolerance
Induction
Associated with
Solid Organ
Transplant
Tolerance
Induction
Associated with
Solid Organ
Transplant
Tolerance
Induction
Associated with
Solid Organ
Transplant
Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times
Current Information Collection Data
Element (if applicable)
yes
no
Specify solid organ transplanted (check all
that apply)
Kidney,Liver,Other organ,Pancreas
Specify solid organ transplanted
(check all that apply)
Kidney,Liver,Other organ,Pancreas
yes
no
Specify other organ:
open text
Specify other organ:
open text
yes
no
Specify other disease:
open text
open text
yes
First Name (person completing form):
open text
Specify other disease:
First Name (person completing
form):
yes
Last Name:
open text
Last Name:
open text
yes
E-mail address:
open text
E-mail address:
open text
yes
Date:
YYYY/MM/DD
Date:
YYYY/MM/DD
SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll
Current Information Collection Data
Element Response Option(s)
Information Collection update:
Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Rationale for Information Collection Update
open text
Page 50 of 50
| File Type | application/pdf |
| File Title | SCTOD Information Collection_to HRSA 2022-03-29.xlsx |
| Author | doleysh |
| File Modified | 2022-03-29 |
| File Created | 2022-03-29 |