Post-Transplant Periodic Information Collection based on Predetermined Schedule

Information Collection Domain: Post-Transplant Periodic Information Collection
Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

PostTransplant
Essential Data

no

yes

PostTransplant
Essential Data

no

PostTransplant
Essential Data

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Sequence Number:

Auto Filled Field

Sequence Number:

Auto Filled Field

yes

Date Received:

Auto Filled Field

Date Received:

Auto Filled Field

no

yes

CIBMTR Center Number:

Auto Filled Field

CIBMTR Center Number:

Auto Filled Field

PostTransplant
Essential Data

no

yes

CIBMTR Research ID:

Auto Filled Field

CIBMTR Research ID:

Auto Filled Field

PostTransplant
Essential Data

no

yes

Event date:

Auto Filled Field created with CRID

Event date:

Auto Filled Field created with CRID

PostTransplant
Essential Data

no

yes

Visit

100 day,1 year,2 years,> 2 years,6
months

Visit

100 day,1 year,2 years,> 2 years,6 months

PostTransplant
Essential Data

no

yes

Specify:

open text

Specify:

open text

PostTransplant
Essential Data

no

yes

Date of actual contact with the recipient to
determine medical status for this follow-up
report:
YYYY/MM/DD

PostTransplant
Essential Data

no

yes

Specify the recipient's survival status at the
date of last contact
Alive,Dead

Did the recipient receive a
subsequent HCT since the date of last
report?
no,yes

Date of subsequent HCT:

YYYY/MM/DD

What was the indication for
subsequent 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

PostTransplant
Essential Data

no

yes

Did the recipient receive a subsequent HCT
since the date of last report?
no,yes

PostTransplant
Subsequent
Essential Data Transplant

yes

yes

Date of subsequent HCT:

YYYY/MM/DD

What was the indication for subsequent
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

PostTransplant
Subsequent
Essential Data Transplant

yes

yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Rationale for Information Collection Update

Date of actual contact with the
recipient to determine medical status
for this follow-up report:
YYYY/MM/DD

Change/Clarification of Response Options

Specify the recipient's survival status
at the date of last contact
Alive,Dead (Complete recipient death data)

Capture additional relevent disease information

Page 1 of 19

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

PostTransplant
Subsequent
Essential Data Transplant

yes

yes

PostTransplant
Subsequent
Essential Data Transplant

yes

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Specify other indication:

open text

Specify other indication:

open text

yes

Source of HSCs (check all that apply)

Allogeneic, related,Allogeneic,
unrelated,Autologous

Source of HSCs (check all that apply)

Allogeneic, related,Allogeneic, unrelated,Autologous

Has the recipient received a cellular therapy
since the date of last report? (e.g. CAR-T,
DCI)
no,yes

PostTransplant
Essential Data

no

yes

PostTransplant
Subsequent
Essential Data Transplant

yes

yes

Addition of Information Requested

Was this infusion a donor lymphocyte
infusion (DLI)?
no,yes

PostTransplant
Subsequent
Essential Data Transplant

yes

yes

Addition of Information Requested

Number of DLIs in this reporting
period

Addition of Information Requested

Are any of the products, associated
with this course of cellular therapy,
genetically modified?

no, yes

Has the recipient received a cellular
therapy since the date of last report?
(e.g. CAR-T, DCI)
no,yes

Date of cellular therapy:

YYYY/MM/DD

Capture additional relevent disease information

yes

yes

PostTransplant
Subsequent
Essential Data Transplant

yes

yes

Date of cellular therapy:

Was there evidence of initial
hematopoietic recovery?

No(ANC ≥ 500/mm3 was not achieved) ,Not
applicable(ANC never dropped below 500/mm3 at any
time after the start of the preparative regimen,Previously
reported(recipient’s initial hematopoietic recovery was
recorded on a previous report) ,Yes(ANC ≥ 500/mm3
achieved and sustained for 3 lab values)

PostTransplant
Essential Data

no

yes

No(ANC ≥ 500/mm3 was not achieved)
,Not applicable(ANC never dropped
below 500/mm3 at any time after the
start of the preparative
regimen,Previously reported(recipient’s
initial hematopoietic recovery was
recorded on a previous report) ,Yes(ANC
Was there evidence of initial hematopoietic ≥ 500/mm3 achieved and sustained for 3
recovery?
lab values)

PostTransplant
Essential Data

no

yes

Date ANC ≥ 500/mm³ (first of 3 lab values): YYYY/MM/DD

Date ANC ≥ 500/mm³ (first of 3 lab
values):

YYYY/MM/DD

PostTransplant
Essential Data

no

yes

Did late graft failure occur?

No,Yes
No,Not applicable(Platelet count never
dropped below 20 x 109/L) ,Previously
reported(≥ 20 x 109/L was achieved and
reported previously),Yes

Did late graft failure occur?

No,Yes

Was an initial platelet count ≥ 20 x
109/L achieved?

No,Not applicable(Platelet count never dropped below 20
x 109/L) ,Previously reported(≥ 20 x 109/L was achieved
and reported previously),Yes

YYYY/MM/DD

Date platelets ≥ 20 x 109/L:

YYYY/MM/DD

PostTransplant
Essential Data

no

yes

Was an initial platelet count ≥ 20 x 109/L
achieved?

PostTransplant
Essential Data

no

yes

Date platelets ≥ 20 x 109/L:

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Capture additional relevent disease information

__ __

PostTransplant
Subsequent
Essential Data Transplant

YYYY/MM/DD

Rationale for Information Collection Update

Capture additional relevent disease information

Page 2 of 19

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

PostTransplant
Essential Data

no

yes

PostTransplant
Graft vs. Host
Essential Data Disease

yes

PostTransplant
Graft vs. Host
Essential Data Disease

yes

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

PostTransplant
Graft vs. Host
Essential Data Disease

PostTransplant
Graft vs. Host
Essential Data Disease

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

yes

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Did acute GVHD develop since the date of
last report?

No,Unknown,Yes

Did acute GVHD develop since the
date of last report?

No,Unknown,Yes

yes

Date of acute GVHD diagnosis:

YYYY/MM/DD

Date of acute GVHD diagnosis:

YYYY/MM/DD

yes

Did acute GVHD persist since the date of
last report?

No,Unknown,Yes

Did acute GVHD persist since the date
of last report?
No,Unknown,Yes

Overall grade of acute GVHD at diagnosis

I - Rash on ≤ 50% of skin, no liver or gut
involvement
II - Rash on > 50% of skin, bilirubin 2-3
mg/dL, or diarrhea 500 – 1000 mL/day or
persistent nausea or vomiting
III - Bilirubin 3-15 mg/dL, or gut stage 2-4
diarrhea > 1000 mL/day or severe
abdominal pain with or without ileus
IV - Generalized erythroderma with
bullous formation, or bilirubin >15 mg/dL
Not applicable (acute GVHD present but
cannot be graded)

Overall grade of acute GVHD at
diagnosis

yes

Skin

Stage 0 – No rash, no rash attributable to
acute GVHD
Stage 1 – Maculopapular rash, < 25% of
body surface
Stage 2 – Maculopapular rash, 25–50% of
body surface
Stage 3 – Generalized erythroderma, >
50% of body surface
Stage 4 – Generalized erythroderma with
bullae formation and/or desquamation

Skin

yes

Stage 0 – No diarrhea, no diarrhea
attributable to acute GVHD / diarrhea <
500 mL/day (adult), or < 10 mL/kg/day
(pediatric)
Stage 1 – Diarrhea 500 - 1000 mL/day
(adult), or 10 - 19.9 mL/kg/day (pediatric)
Stage 2 – Diarrhea 1001 - 1500 mL/day
(adult), or 20 - 30 mL/kg/day (pediatric)
Stage 3 – Diarrhea > 1500 mL/day (adult),
Lower intestinal tract (use mL/day for adult or > 30 mL/kg/day (pediatric)
recipients and mL/kg/day for pediatric
Stage 4 – Severe abdominal pain, with or
recipients)
without ileus, and/or grossly bloody stool

yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Rationale for Information Collection Update

I - Rash on ≤ 50% of skin, no liver or gut involvement
II - Rash on > 50% of skin, bilirubin 2-3 mg/dL, or diarrhea
500 – 1000 mL/day or persistent nausea or vomiting
III - Bilirubin 3-15 mg/dL, or gut stage 2-4 diarrhea > 1000
mL/day or severe abdominal pain with or without ileus
IV - Generalized erythroderma with bullous formation, or
bilirubin >15 mg/dL
Not applicable (acute GVHD present but cannot be
graded)
Stage 0 – No rash, no rash attributable to acute GVHD
Stage 1 – Maculopapular rash, < 25% of body surface
Stage 2 – Maculopapular rash, 25–50% of body surface
Stage 3 – Generalized erythroderma, > 50% of body
surface
Stage 4 – Generalized erythroderma with bullae
formation and/or desquamation

Stage 0 – No diarrhea, no diarrhea attributable to acute
GVHD / diarrhea < 500 mL/day (adult), or < 10 mL/kg/day
(pediatric)
Stage 1 – Diarrhea 500 - 1000 mL/day (adult), or 10 - 19.9
mL/kg/day (pediatric)
Stage 2 – Diarrhea 1001 - 1500 mL/day (adult), or 20 - 30
mL/kg/day (pediatric)
Stage 3 – Diarrhea > 1500 mL/day (adult), or > 30
Lower intestinal tract (use mL/day for mL/kg/day (pediatric)
adult recipients and mL/kg/day for
Stage 4 – Severe abdominal pain, with or without ileus,
pediatric recipients)
and/or grossly bloody stool

Page 3 of 19

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

PostTransplant
Graft vs. Host
Essential Data Disease

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Upper intestinal tract

Stage 0 – No persistent nausea or vomiting
Stage 1 – Persistent nausea or vomiting

Liver

Stage 0 – No liver acute GVHD / bilirubin < 2.0 mg/dL (<
34 μmol/L)
Stage 1 – Bilirubin 2.0–3.0 mg/dL (34–52 μmol/L)
Stage 2 – Bilirubin 3.1–6.0 mg/dL (53–103 μmol/L)
Stage 3 – Bilirubin 6.1–15.0 mg/dL (104–256 μmol/L)
Stage 4 – Bilirubin > 15.0 mg/dL (> 256 μmol/L)

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Liver

Stage 0 – No persistent nausea or
vomiting
Stage 1 – Persistent nausea or vomiting
Stage 0 – No liver acute GVHD / bilirubin
< 2.0 mg/dL (< 34 μmol/L)
Stage 1 – Bilirubin 2.0–3.0 mg/dL (34–52
μmol/L)
Stage 2 – Bilirubin 3.1–6.0 mg/dL (53–103
μmol/L)
Stage 3 – Bilirubin 6.1–15.0 mg/dL
(104–256 μmol/L)
Stage 4 – Bilirubin > 15.0 mg/dL (> 256
μmol/L)

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Other site(s) involved with acute GVHD

No,Yes

Other site(s) involved with acute
GVHD

No,Yes

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Specify other site(s):

open text

Specify other site(s):

open text

Maximum overall grade of acute
GVHD

I - Rash on ≤ 50% of skin, no liver or gut involvement
II - Rash on > 50% of skin, bilirubin 2-3 mg/dL, or diarrhea
500 – 1000 mL/day or persistent nausea or vomiting
III - Bilirubin 3-15 mg/dL, or gut stage 2-4 diarrhea > 1000
mL/day or severe abdominal pain with or without ileus
IV - Generalized erythroderma with bullous formation, or
bilirubin >15 mg/dL
Not applicable (acute GVHD present but cannot be
graded)

First date maximum overall grade of
acute GVHD:

YYYY/MM/DD

Skin

Stage 0 – No rash, no rash attributable to acute GVHD
Stage 1 – Maculopapular rash, < 25% of body surface
Stage 2 – Maculopapular rash, 25–50% of body surface
Stage 3 – Generalized erythroderma, > 50% of body
surface
Stage 4 – Generalized erythroderma with bullae
formation and/or desquamation

yes

yes

Upper intestinal tract

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Maximum overall grade of acute GVHD

I - Rash on ≤ 50% of skin, no liver or gut
involvement
II - Rash on > 50% of skin, bilirubin 2-3
mg/dL, or diarrhea 500 – 1000 mL/day or
persistent nausea or vomiting
III - Bilirubin 3-15 mg/dL, or gut stage 2-4
diarrhea > 1000 mL/day or severe
abdominal pain with or without ileus
IV - Generalized erythroderma with
bullous formation, or bilirubin >15 mg/dL
Not applicable (acute GVHD present but
cannot be graded)

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Date maximum overall grade of acute
GVHD:

YYYY/MM/DD

Skin

Stage 0 – No rash, no rash attributable to
acute GVHD
Stage 1 – Maculopapular rash, < 25% of
body surface
Stage 2 – Maculopapular rash, 25–50% of
body surface
Stage 3 – Generalized erythroderma, >
50% of body surface
Stage 4 – Generalized erythroderma with
bullae formation and/or desquamation

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Change/Clarification of Information
Requested

Rationale for Information Collection Update

Capture data accurately

Page 4 of 19

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

PostTransplant
Graft vs. Host
Essential Data Disease
PostTransplant
Graft vs. Host
Essential Data Disease

Response
required if
Additional Sub
Domain
applies

yes

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

yes

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Stage 0 – No diarrhea, no diarrhea
attributable to acute GVHD / diarrhea <
500 mL/day (adult), or < 10 mL/kg/day
(pediatric)
Stage 1 – Diarrhea 500 - 1000 mL/day
(adult), or 10 - 19.9 mL/kg/day (pediatric)
Stage 2 – Diarrhea 1001 - 1500 mL/day
(adult), or 20 - 30 mL/kg/day (pediatric)
Stage 3 – Diarrhea > 1500 mL/day (adult),
Lower intestinal tract (use mL/day for adult or > 30 mL/kg/day (pediatric)
recipients and mL/kg/day for pediatric
Stage 4 – Severe abdominal pain, with or
recipients)
without ileus, and/or grossly bloody stool

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Stage 0 – No diarrhea, no diarrhea attributable to acute
GVHD / diarrhea < 500 mL/day (adult), or < 10 mL/kg/day
(pediatric)
Stage 1 – Diarrhea 500 - 1000 mL/day (adult), or 10 - 19.9
mL/kg/day (pediatric)
Stage 2 – Diarrhea 1001 - 1500 mL/day (adult), or 20 - 30
mL/kg/day (pediatric)
Stage 3 – Diarrhea > 1500 mL/day (adult), or > 30
Lower intestinal tract (use mL/day for mL/kg/day (pediatric)
adult recipients and mL/kg/day for
Stage 4 – Severe abdominal pain, with or without ileus,
pediatric recipients)
and/or grossly bloody stool

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Liver

Stage 0 – No persistent nausea or
vomiting
Stage 1 – Persistent nausea or vomiting
Stage 0 – No liver acute GVHD / bilirubin
< 2.0 mg/dL (< 34 μmol/L)
Stage 1 – Bilirubin 2.0–3.0 mg/dL (34–52
μmol/L)
Stage 2 – Bilirubin 3.1–6.0 mg/dL (53–103
μmol/L)
Stage 3 – Bilirubin 6.1–15.0 mg/dL
(104–256 μmol/L)
Stage 4 – Bilirubin > 15.0 mg/dL (> 256
μmol/L)

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Other site(s) involved with acute GVHD

No,Yes

Other site(s) involved with acute
GVHD

No,Yes

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Specify other site(s):

open text

Specify other site(s):

open text

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Did chronic GVHD develop since the date of
last report?
No,Unknown,Yes

Did chronic GVHD develop since the
date of last report?

No,Unknown,Yes

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Date of chronic GVHD diagnosis:

YYYY/MM/DD

Date of chronic GVHD diagnosis:

YYYY/MM/DD

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Date estimated

checked

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Did chronic GVHD persist since the date of
last report?

No,Unknown,Yes

yes

yes

Upper intestinal tract

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Rationale for Information Collection Update

Upper intestinal tract

Stage 0 – No persistent nausea or vomiting
Stage 1 – Persistent nausea or vomiting

Liver

Stage 0 – No liver acute GVHD / bilirubin < 2.0 mg/dL (<
34 μmol/L)
Stage 1 – Bilirubin 2.0–3.0 mg/dL (34–52 μmol/L)
Stage 2 – Bilirubin 3.1–6.0 mg/dL (53–103 μmol/L)
Stage 3 – Bilirubin 6.1–15.0 mg/dL (104–256 μmol/L)
Stage 4 – Bilirubin > 15.0 mg/dL (> 256 μmol/L)

Deletion of Information: Merged to Check all
that Apply
Date estimated

Did chronic GVHD persist since the
date of last report?

checked

Reduce burden: expanded response options to include responses
previously reported manually or created a "check all that apply"

No,Unknown,Yes

Page 5 of 19

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Maximum grade of chronic GVHD
(according to best clinical judgment)

Mild,Moderate,Severe,Unknown

Maximum grade of chronic GVHD
(according to best clinical judgment)

Mild,Moderate,Severe,Unknown

Date of maximum grade of chronic GVHD:

YYYY/MM/DD

Date of maximum grade of chronic
GVHD:

YYYY/MM/DD

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Specify if chronic GVHD was limited or
extensive
Is the recipient still taking systemic
steroids? (Do not report steroids for
adrenal insufficiency, or steroid dose ≤10
mg/day for adults, <0.1 mg/kg/day for
children)

Extensive – One or more of the following:
– Generalized skin involvement; or,
– Liver histology showing chronic
aggressive hepatitis, bridging necrosis or
cirrhosis; or,
– Involvement of eye: Schirmer’s test
with < 5 mm wetting; or
– Involvement of minor salivary glands or
oral mucosa demonstrated on labial
biopsy; or
– Involvement of any other target organ,
Limited - Localized skin involvement
and/or liver dysfunction

No,Not Applicable,Unknown,Yes

Extensive – One or more of the following:
– Generalized skin involvement; or,
– Liver histology showing chronic aggressive hepatitis,
bridging necrosis or cirrhosis; or,
– Involvement of eye: Schirmer’s test with < 5 mm
wetting; or
– Involvement of minor salivary glands or oral mucosa
demonstrated on labial biopsy; or
Specify if chronic GVHD was limited or – Involvement of any other target organ, Limited extensive
Localized skin involvement and/or liver dysfunction
Is the recipient still taking systemic
steroids? (Do not report steroids for
adrenal insufficiency, or steroid dose
≤10 mg/day for adults, <0.1
mg/kg/day for children)
No,Not Applicable,Unknown,Yes

No,Not Applicable,Unknown,Yes

Is the recipient still taking (nonsteroid) immunosuppressive agents
(including PUVA) for GVHD?

PostTransplant
Graft vs. Host
Essential Data Disease

yes

yes

Is the recipient still taking (non-steroid)
immunosuppressive agents (including
PUVA) for GVHD?

PostTransplant
Essential Data

no

yes

Was specific therapy used to prevent liver
toxicity?

No,Yes

Was specific therapy used to prevent
liver toxicity?
No,Yes
Defibrotide,N-acetylcysteine,Other therapy,Tissue
plasminogen activator (TPA),Ursodiol, Enoxaparin
Specify therapy (check all that apply) (Lovenox), Heparin

PostTransplant
Essential Data

no

yes

Specify therapy (check all that apply)

Defibrotide,N-acetylcysteine,Other
therapy,Tissue plasminogen activator
(TPA),Ursodiol

PostTransplant
Essential Data

no

yes

Specify other therapy:

open text

PostTransplant
Essential Data

no

yes

Did veno-occlusive disease (VOD) /
sinusoidal obstruction syndrome (SOS)
develop since the date of last report?

PostTransplant
Essential Data

no

yes

Date of diagnosis:

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Change/Clarification of Response Options

Rationale for Information Collection Update

No,Not Applicable,Unknown,Yes

open text

No,Yes

Specify other therapy:
Did veno-occlusive disease (VOD) /
sinusoidal obstruction syndrome
(SOS) develop since the date of last
report?

YYYY/MM/DD

Date of diagnosis:

YYYY/MM/DD

Be consistent with current clinical landscape, improve transplant
outcome data

No,Yes

Page 6 of 19

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Did the recipient develop COVID-19
(SARS-CoV-2) since the date of last
report?

No,Yes

PostTransplant
Essential Data

no

yes

Did the recipient develop COVID-19 (SARSCoV-2) since the date of last report?
No,Yes

PostTransplant
Essential Data

no

yes

Date of diagnosis:

YYYY/MM/DD

Date of diagnosis:

YYYY/MM/DD

PostTransplant
Essential Data

no

yes

Was a vaccine for COVID-19 (SARS-CoV-2)
received?

No,Unknown,Yes

Was a vaccine for COVID-19 (SARSCoV-2) received?

No,Unknown,Yes

Specify vaccine brand

AstraZeneca,Johnson & Johnson,Moderna,Novavax,Other
(specify),Pfizer-BioNTech

Specify other type:

open text

PostTransplant
Essential Data Covid-19 Vaccine

yes

yes

Specify vaccine brand

AstraZeneca,Johnson &
Johnson,Moderna,Novavax,Other
(specify),Pfizer-BioNTech

PostTransplant
Essential Data Covid-19 Vaccine

yes

yes

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

Rationale for Information Collection Update

PostTransplant
Essential Data Covid-19 Vaccine

yes

yes

Select dose(s) received

Booster dose,First dose(with planned
second dose) ,One dose(without planned
second dose) ,Second dose,Third dose

PostTransplant
Essential Data Covid-19 Vaccine

yes

yes

Date received:

YYYY/MM/DD

Date received:

YYYY/MM/DD

PostTransplant
Essential Data Covid-19 Vaccine

yes

yes

Date estimated

checked

Date estimated

checked

No,Yes

Did a new malignancy,
myelodysplastic, myeloproliferative,
or lymphoproliferative disease /
disorder occur that is different from
the disease / disorder for which the
HCT or cellular therapy was
performed?

No,Yes (Also complete Subsequent Neoplasms) , previosly
reported
Capture additional relevent disease information

no,yes

Were chimerism studies performed
since the date of last report?

no,yes

PostTransplant
Essential Data

no

yes

Did a new malignancy, myelodysplastic,
myeloproliferative, or lymphoproliferative
disease / disorder occur that is different
from the disease / disorder for which the
HCT or cellular therapy was performed?

Allogenic Recipients
of Cord Blood units,
PostBeta Thalassemia,
Transplant
and/or Sickle Cell
Essential Data Disease

yes

yes

Were chimerism studies performed since
the date of last report?

yes

Was documentation submitted to the
CIBMTR? (e.g. chimerism laboratory
reports)

No,Yes

Was documentation submitted to the
CIBMTR? (e.g. chimerism laboratory
reports)
No,Yes

yes

Were chimerism studies assessed for more
than one donor / multiple donors?
No,Yes

Were chimerism studies assessed for
more than one donor / multiple
donors?
No,Yes

PostTransplant
Chimerism Study
Essential Data Performed
PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Change/Clarification of Response Options

Page 7 of 19

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

PostTransplant
Chimerism Study
Essential Data Performed

yes

PostTransplant
Chimerism Study
Essential Data Performed

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Global Registration Identifier for Donors
(GRID)

open text

Global Registration Identifier for
Donors (GRID)

open text

yes

NMDP cord blood unit ID:

open text

NMDP cord blood unit ID:

open text

yes

yes

Registry donor ID:

open text

Registry donor ID:

open text

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Non-NMDP cord blood unit ID:

open text

Non-NMDP cord blood unit ID:

open text

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Date of birth:

YYYY/MM/DD

Donor Date of birth:

YYYY/MM/DD

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Age:

MM __ __ (if less than 1 year); YY __ __
__

Age:

MM __ __ (if less than 1 year); YY __ __ __

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Sex

female,male

Donor Sex

female,male

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Date sample collected:

Date sample collected:

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Method

YYYY/MM/DD
Fluorescent in situ hybridization (FISH)
for XX/XY,Karyotyping for
XX/XY,Other,Restriction fragment-length
polymorphisms (RFLP),VNTR or STR,
micro or mini satellite
Change/Clarification of Response Options

Method

YYYY/MM/DD
PCR(includes quantitative, real time, and fluorescent
multiplex), Fluorescent in situ hybridization (FISH) for
XX/XY,Karyotyping for XX/XY,Other,Restriction fragmentlength polymorphisms (RFLP),VNTR or STR, micro or mini
satellite
Examples added or typographical errors corrected for clarification

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Specify:

open text

Specify:

open text

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Cell source

Cell source

Bone marrow,Peripheral blood

Cell type

B-cells,Granulocytes,Hematopoietic progenitor cells,NK
cells,Other,Red blood cells,T-cells,Total mononuclear
cells,Unsorted / whole

Specify:

open text

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Cell type

Bone marrow,Peripheral blood
B-cells,Granulocytes,Hematopoietic
progenitor cells,NK cells,Other,Red blood
cells,T-cells,Total mononuclear
cells,Unsorted / whole

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

Specify:

open text

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Change/Clarification of Information
Requested

Change/Clarification of Information
Requested

Rationale for Information Collection Update

Capture data accurately

Capture data accurately

Page 8 of 19

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

PostTransplant
Chimerism Study
Essential Data Performed

yes

yes

PostTransplant
Chimerism Study
Essential Data Performed

yes

PostTransplant
Chimerism Study
Essential Data Performed

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

PostTransplant
Chimerism Study
Essential Data Performed
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Total cells examined:

open text

Total cells examined:

open text

yes

Number of donor cells:

open text

Number of donor cells:

open text

yes

yes

Were donor cells detected?

No,Yes

Were donor cells detected?

No,Yes

yes

yes

Percent donor cells:

__ __ __ %

Percent donor cells:

__ __ __ %

no

yes

Compared to the disease status prior to the
preparative regimen, what was the best
Continued complete remission
response to HCT since the date of the last (CCR),Complete remission (CR),Not in
report?
complete remission,Not evaluated

Compared to the disease status prior
to the preparative regimen, what was
the best response to HCT since the
Continued complete remission (CCR),Complete remission
date of the last report?
(CR),Not in complete remission,Not evaluated

no

yes

Specify disease status if not in complete
remission

Disease detected,No disease detected
but incomplete evaluation to establish CR

Specify disease status if not in
complete remission

Disease detected,No disease detected but incomplete
evaluation to establish CR

no

yes

Was the date of best response previously
reported?

no,yes

Was the date of best response
previously reported?

no,yes

no

yes

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

no

yes

Was the disease status assessed by
molecular testing?

No,Not Applicable,Yes

Was the disease status assessed by
molecular testing?

No,Not Applicable,Yes

no

yes

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Deletion of Information Requested

Rationale for Information Collection Update

Reduce redundancy in data capture

Page 9 of 19

Information
Collection
Domain SubType
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT

Information
Collection Domain
Additional Sub
Domain

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

no

yes

no

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Was disease detected?

no,yes

Was disease detected?

no,yes

yes

Was the disease status assessed via flow
cytometry?

No,Not Applicable,Yes

Was the disease status assessed via
flow cytometry?

No,Not Applicable,Yes

no

yes

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

no

yes

Was disease detected?

no,yes

Was disease detected?

no,yes

no

yes

Was the disease status assessed by
cytogenetic testing? (karyotyping or FISH)

No,Not Applicable,Yes

Was the disease status assessed by
cytogenetic testing? (karyotyping or
FISH)

No,Not Applicable,Yes

no

yes

Was the disease status assessed via FISH?

No,Not Applicable,Yes

Was the disease status assessed via
FISH?

No,Not Applicable,Yes

no

yes

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

no

yes

Was disease detected?

no,yes

Was disease detected?

no,yes

no

yes

Was the disease status assessed via
karyotyping?

No,Not Applicable,Yes

Was the disease status assessed via
karyotyping?

No,Not Applicable,Yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Rationale for Information Collection Update

Page 10 of 19

Information
Collection
Domain SubType
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT
Disease
Assessment
at the Time of
Best
Response to
HCT

Post-HCT
Therapy

Information
Collection Domain
Additional Sub
Domain

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

no

yes

no

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

yes

Was disease detected?

no,yes

Was disease detected?

no,yes

no

yes

Was the disease status assessed by
radiological assessment? (e.g. PET, MRI, CT) No,Not Applicable,Yes

Was the disease status assessed by
radiological assessment? (e.g. PET,
MRI, CT)

No,Not Applicable,Yes

no

yes

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

no

yes

Was disease detected?

no,yes

Was disease detected?

no,yes

no

yes

Was the disease status assessed by clinical /
hematologic assessment?
no,yes

Was the disease status assessed by
clinical / hematologic assessment?

no,yes

no

yes

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

no

yes

Was disease detected?

no,yes

Was disease detected?

no,yes

yes

Was therapy given since the date of the last
report for reasons other than relapse,
persistent, or progressive disease? (Include
any maintenance and consolidation
therapy.)
no,yes

no

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Rationale for Information Collection Update

Was therapy given since the date of
the last report for reasons other than
relapse, persistent, or progressive
disease? (Include any maintenance
and consolidation therapy.)
no,yes

Page 11 of 19

Information
Collection
Domain SubType
Post-HCT
Therapy

Post-HCT
Therapy
Post-HCT
Therapy
Post-HCT
Therapy
Post-HCT
Therapy
Post-HCT
Therapy
Post-HCT
Therapy
Post-HCT
Therapy
Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT

Information
Collection Domain
Additional Sub
Domain

Response
required if
Additional Sub
Domain
applies

no

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

yes

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Specify therapy (check all that apply)

Blinded randomized trial,Cellular
therapy,Other
therapy,Radiation,Systemic therapy

Blinded randomized trial,Cellular therapy,Other
Specify therapy (check all that apply) therapy,Radiation,Systemic therapy

Specify systemic therapy (check all
that apply)

Alemtuzumab,Azacytidine,Blinatumomab,Bortezomib,Bo
sutinib,Carfilzomib,Chemotherapy,Dasatinib,Decitabine,G
emtuzumab,Gilteritinib,Ibrutinib,Imatinib
mesylate,Ixazomib,Lenalidomide,Lestaurtinib,Midostauri
n,Nilotinib,Nivolumab,Other systemic
therapy,Pembrolizumab,Pomalidomide,Quizartinib,Rituxi
mab,Sorafenib,Sunitinib,Thalidomide, Brentuximab
Be consistent with current clinical landscape, improve transplant
vendotin, Daratumumab (Darzalex)
outcome data

no

yes

Specify systemic therapy (check all that
apply)

Alemtuzumab,Azacytidine,Blinatumomab
,Bortezomib,Bosutinib,Carfilzomib,Chem
otherapy,Dasatinib,Decitabine,Gemtuzu
mab,Gilteritinib,Ibrutinib,Imatinib
mesylate,Ixazomib,Lenalidomide,Lestaurt
inib,Midostaurin,Nilotinib,Nivolumab,Oth
er systemic
therapy,Pembrolizumab,Pomalidomide,Q
uizartinib,Rituximab,Sorafenib,Sunitinib,T
halidomide
Change/Clarification of Response Options

no

yes

Specify other systemic therapy:

open text

Specify other systemic therapy:

open text

no

yes

Specify other therapy:

open text

open text

no

yes

Addition of Information Requested

Specify other therapy:
Did a fecal microbiota transplant
(FMT) occur since the date of last
report?

no

yes

Addition of Information Requested

Date of FMT

no

yes

Addition of Information Requested

Specify the indication for the FMT

DD/MM/YY
Graft versus host disease (GVHD), Clostridium difficle,
Other

no

yes

Addition of Information Requested

Specify other indication:
Did the recipient experience a
clinical/hematologic relapse or
progression post-HCT?
Was the date of the first clinical /
hematologic relapse or progression
previously reported?

open text

YYYY/MM/DD

Date first seen:

YYYY/MM/DD

No,Yes

Was intervention given for relapsed,
persistent or progressive disease
since the date of last report?

No,Yes

no

yes

no

yes

Did the recipient experience a
clinical/hematologic relapse or progression
post-HCT?
No,Yes
Was the date of the first clinical /
hematologic relapse or progression
previously reported?
No,Yes (only valid >day 100)

no

yes

Date first seen:

no

yes

Was intervention given for relapsed,
persistent or progressive disease since the
date of last report?

no

yes

Specify reason for which intervention was
given

no

yes

Persistent disease,Relapsed / progressive
disease
Clinical and/or hematologic
Specify the method(s) of detection for
analysis,Cytogenetic Analysis,Disease
which intervention was given (check all that specific molecular marker,Flow
apply)
Cytometry,Radiological

no

yes

Date intervention started:

no

yes

Specify therapy (check all that apply)

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

YYYY/MM/DD
Blinded randomized trial,Cellular
therapy,Other
therapy,Radiation,Systemic therapy

No, Yes

Rationale for Information Collection Update

Be consistent with current clinical landscape, improve transplant
outcome data
Be consistent with current clinical landscape, improve transplant
outcome data
Be consistent with current clinical landscape, improve transplant
outcome data
Be consistent with current clinical landscape, improve transplant
outcome data

No,Yes

No,Yes (only valid >day 100)

Specify reason for which intervention
was given
Persistent disease,Relapsed / progressive disease

Date intervention started:

Specify the method(s) of detection for Clinical and/or hematologic analysis,Cytogenetic
which intervention was given (check Analysis,Disease specific molecular marker,Flow
all that apply)
Cytometry,Radiological

YYYY/MM/DD

Blinded randomized trial,Cellular therapy,Other
Specify therapy (check all that apply) therapy,Radiation,Systemic therapy

Page 12 of 19

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Specify systemic therapy (check all
that apply)

Alemtuzumab,Azacytidine,Blinatumomab,Bortezomib,Bo
sutinib,Carfilzomib,Chemotherapy,Dasatinib,Decitabine,G
emtuzumab,Gilteritinib,Ibrutinib,Imatinib
mesylate,Ixazomib,Lenalidomide,Lestaurtinib,Midostauri
n,Nilotinib,Nivolumab,Other systemic
therapy,Pembrolizumab,Pomalidomide,Quizartinib,Rituxi
mab,Sorafenib,Sunitinib,Thalidomide, Daratumumb
Be consistent with current clinical landscape, improve transplant
(Darzalex), Venetoclax
outcome data

no

yes

Specify systemic therapy (check all that
apply)

Alemtuzumab,Azacytidine,Blinatumomab
,Bortezomib,Bosutinib,Carfilzomib,Chem
otherapy,Dasatinib,Decitabine,Gemtuzu
mab,Gilteritinib,Ibrutinib,Imatinib
mesylate,Ixazomib,Lenalidomide,Lestaurt
inib,Midostaurin,Nilotinib,Nivolumab,Oth
er systemic
therapy,Pembrolizumab,Pomalidomide,Q
uizartinib,Rituximab,Sorafenib,Sunitinib,T
halidomide
Change/Clarification of Response Options

no

yes

Specify other systemic therapy:

open text

Specify other systemic therapy:

open text

no

yes

Specify other therapy:

open text

Specify other therapy:

open text

no

yes

What is the current disease status?

Complete remission (CR),Not in complete
remission,Not evaluated

What is the current disease status?

Complete remission (CR),Not in complete remission,Not
evaluated

no

yes

Specify disease status if not in complete
remission

Disease detected,No disease detected
but incomplete evaluation to establish CR

Specify disease status if not in
complete remission

Disease detected,No disease detected but incomplete
evaluation to establish CR

no

yes

Date of most recent disease assessment

Known,Unknown

Deletion of Information Requested

no

yes

Date of most recent disease assessment:

YYYY/MM/DD

Change/Clarification of Information
Requested

Date of most recent disease
assessment
Known,Unknown
Date of most recent disease
assessment
Date
of assesment of current disease
status
YYYY/MM/DD

Recipient Death

yes

no

Addition of Information Requested

Date of death:

Recipient Death

yes

no

Addition of Information Requested

Recipient Death

yes

no

Addition of Information Requested

Recipient Death

yes

no

Addition of Information Requested

Date estimated
checked
Was cause of death confirmed by
autopsy?
Autopsy pending,No,Unknown,Yes
Was documentation submitted to the
CIBMTR?
No,Yes

Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT
Relapse or
Progression
Post-HCT
Current
Disease
Status
Current
Disease
Status
Current
Disease
Status
Current
Disease
Status
Recipient
Death Data
Recipient
Death Data
Recipient
Death Data
Recipient
Death Data

Response
required if
Additional Sub
Domain
applies

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

YYYY/MM/DD

Rationale for Information Collection Update

Reduce redundancy in data capture

Reduce redundancy in data capture
Reduce redundancy in data capture
Reduce redundancy in data capture
Reduce redundancy in data capture
Reduce redundancy in data capture

Page 13 of 19

Information
Collection
Domain SubType

Recipient
Death Data
Recipient
Death Data

Information
Collection Domain
Additional Sub
Domain

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

Current Information Collection Data

Recipient Death

yes

no

Primary cause of death

Element Response
Option(s)
Information Collection update:
Accidental
death,Acute
GVHD,Adult
respiratory distress syndrome (ARDS)
(other than IPS),Bacterial
infection,Cardiac failure,Chronic
GVHD,Central nervous system (CNS)
failure,COVID-19 (SARS-CoV-2),Cytokine
release syndrome,Diffuse alveolar
damage (without hemorrhage),
Disseminated intravascular coagulation
(DIC),Fungal infection, Gastrointestinal
(GI) failure (not liver),Graft rejection or
failure, Thrombotic microangiopathy
(TMA) (Thrombotic thrombocytopenic
purpura (TTP)/Hemolytic Uremic
Syndrome (HUS)),Idiopathic pneumonia
syndrome (IPS), Liver failure (not
VOD),Multiple organ failure,New
malignancy,Infection, organism not
identified,Other cause, Other
infection,Other organ failure,Other
pulmonary syndrome (excluding
pulmonary hemorrhage),Other
vascular,Prior malignancy,Protozoal
infection, Pulmonary failure,Recurrence /
persistence / progression of
disease,Renal
failure,Suicide,Thromboembolic,
Pneumonitis due to Cytomegalovirus
(CMV),Viral infection,Pneumonitis due to Change/Clarification of Response Options

Recipient Death

yes

no

Specify:

open text

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Primary cause of death

Accidental death,Acute GVHD,Adult respiratory distress
syndrome (ARDS) (other than IPS),Bacterial
infection,Cardiac failure,Chronic GVHD,Central nervous
system (CNS) failure,COVID-19 (SARS-CoV-2),Cytokine
release syndrome,Diffuse alveolar damage (without
hemorrhage),Diffuse alveolar hemorrhage
(DAH),Disseminated intravascular coagulation
(DIC),Fungal infection,Gastrointestinal
hemorrhage,Gastrointestinal (GI) failure (not liver),Graft
rejection or failure,Hemorrhagic cystitis,Thrombotic
microangiopathy (TMA) (Thrombotic thrombocytopenic
purpura (TTP)/Hemolytic Uremic Syndrome
(HUS)),Idiopathic pneumonia syndrome (IPS),Intracranial
hemorrhage,Liver failure (not VOD),Multiple organ
failure,New malignancy,Infection, organism not
identified,Other cause,Other hemorrhage neurotoxicity
(ICANS), Other infection,Other organ failure,Other
pulmonary syndrome (excluding pulmonary
hemorrhage),Other vascular,Prior malignancy,Protozoal
infection,Pulmonary hemorrhage,Pulmonary
failure,Recurrence / persistence / progression of
disease,Renal failure,Suicide,Thromboembolic, Tumor
lysis syndrome, Pneumonitis due to Cytomegalovirus
(CMV),Viral infection,Pneumonitis due to other
virus,Veno-occlusive disease (VOD) / sinusoidal
Be consistent with current clinical landscape, improve transplant
obstruction syndrome (SOS)
outcome data

Specify:

open text

Rationale for Information Collection Update

Page 14 of 19

Information
Collection
Domain SubType

Recipient
Death Data
Recipient
Death Data

Information
Collection Domain
Additional Sub
Domain

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

Current Information Collection Data

Recipient Death

yes

no

Contributing cause of death

Element Response
Option(s)
Information Collection update:
Accidental
death,Acute
GVHD,Adult
respiratory distress syndrome (ARDS)
(other than IPS),Bacterial
infection,Cardiac failure,Chronic
GVHD,Central nervous system (CNS)
failure,COVID-19 (SARS-CoV-2),Cytokine
release syndrome,Diffuse alveolar
damage (without hemorrhage),
Disseminated intravascular coagulation
(DIC),Fungal infection, Gastrointestinal
(GI) failure (not liver),Graft rejection or
failure, Thrombotic microangiopathy
(TMA) (Thrombotic thrombocytopenic
purpura (TTP)/Hemolytic Uremic
Syndrome (HUS)),Idiopathic pneumonia
syndrome (IPS), Liver failure (not
VOD),Multiple organ failure,New
malignancy,Infection, organism not
identified,Other cause, Other
infection,Other organ failure,Other
pulmonary syndrome (excluding
pulmonary hemorrhage),Other
vascular,Prior malignancy,Protozoal
infection, Pulmonary failure,Recurrence /
persistence / progression of
disease,Renal
failure,Suicide,Thromboembolic,
Pneumonitis due to Cytomegalovirus
(CMV),Viral infection,Pneumonitis due to Change/Clarification of Response Options

Recipient Death

yes

no

Specify:

open text

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Contributing cause of death

Accidental death,Acute GVHD,Adult respiratory distress
syndrome (ARDS) (other than IPS),Bacterial
infection,Cardiac failure,Chronic GVHD,Central nervous
system (CNS) failure,COVID-19 (SARS-CoV-2),Cytokine
release syndrome,Diffuse alveolar damage (without
hemorrhage),Diffuse alveolar hemorrhage
(DAH),Disseminated intravascular coagulation
(DIC),Fungal infection,Gastrointestinal
hemorrhage,Gastrointestinal (GI) failure (not liver),Graft
rejection or failure,Hemorrhagic cystitis,Thrombotic
microangiopathy (TMA) (Thrombotic thrombocytopenic
purpura (TTP)/Hemolytic Uremic Syndrome
(HUS)),Idiopathic pneumonia syndrome (IPS),Intracranial
hemorrhage,Liver failure (not VOD),Multiple organ
failure,New malignancy,Infection, organism not
identified,Other cause,Other hemorrhage neurotoxicity
(ICANS), Other infection,Other organ failure,Other
pulmonary syndrome (excluding pulmonary
hemorrhage),Other vascular,Prior malignancy,Protozoal
infection,Pulmonary hemorrhage,Pulmonary
failure,Recurrence / persistence / progression of
disease,Renal failure,Suicide,Thromboembolic, Tumor
lysis syndrome, Pneumonitis due to Cytomegalovirus
(CMV),Viral infection,Pneumonitis due to other
virus,Veno-occlusive disease (VOD) / sinusoidal
Be consistent with current clinical landscape, improve transplant
obstruction syndrome (SOS)
outcome data

Specify:

open text

Rationale for Information Collection Update

Page 15 of 19

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Hematologic Malignancy: Acute myeloid
leukemia (AML / ANLL), Other leukemia,
Myelodysplastic syndrome (MDS),
Myeloproliferative neoplasm (MPN),
Overlapping myelodysplasia /
myeloproliferative neoplasm (MDS /
MPN), Hodgkin lymphoma, Non-Hodgkin
lymphoma, Clonal cytogenetic
abnormality without leukemia or MDS,
Uncontrolled proliferation of donor cells
without malignant transformation
Solid Tumors: Oropharyngeal cancer

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

Rationale for Information Collection Update

Hematologic Malignancy: Acute myeloid leukemia (AML /
ANLL), Acute lymphoblastic leukemia (ALL), Other
leukemia, Myelodysplastic syndrome (MDS),
Myeloproliferative neoplasm (MPN), Overlapping
myelodysplasia / myeloproliferative neoplasm (MDS /
MPN), Hodgkin lymphoma, Non-Hodgkin lymphoma,
Multiple myeloma / plasma cell neoplasms, Clonal
cytogenetic abnormality without leukemia or MDS,
Uncontrolled proliferation of donor cells without
malignant transformation.
Solid Tumors: Bone sarcoma (regardless of site), Soft

(e.g. tongue, mouth, throat),
Gastrointestinal malignancy (e.g.
esophagus, stomach, small intestine,
colon, rectum, anus, liver, pancreas),
Lung cancer, Melanoma, Squamous
cell skin malignancy, Basal cell skin
malignancy, Breast cancer,
Genitourinary malignancy (e.g.
kidney, bladder, cervix, uterus, ovary,
prostate, testis), Central nervous
system (CNS) malignancy (e.g.
meningioma, glioma), Thyroid cancer

tissue sarcoma (regardless of site), Oropharyngeal
cancer (e.g. tongue, mouth, throat), Gastrointestinal
malignancy (e.g. esophagus, stomach, small
intestine, colon, rectum, anus, liver, pancreas), Lung
cancer, Melanoma, Squamous cell skin malignancy,
Basal cell skin malignancy, Breast cancer,
Genitourinary malignancy (e.g. kidney, bladder,
cervix, uterus, ovary, prostate, testis), Central
nervous system (CNS) malignancy (e.g. meningioma,
glioma), Thyroid cancer
Be consistent with current clinical landscape, improve transplant
outcome data

Change/Clarification of Response Options

Specify the new malignancy

yes

Addition of Information Requested

Was post-transplant
lymphoproliferative disorder (PTLD)
diagnosed?

No,Yes

Be consistent with current clinical landscape, improve transplant
outcome data

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Specify type of PTLD

Monomorphic,Polymorphic,Unknown

Be consistent with current clinical landscape, improve transplant
outcome data

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Specify oropharyngeal cancer

Mouth,Throat,Tongue, Other oropharyngeal cancer

Be consistent with current clinical landscape, improve transplant
outcome data

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Specify gastrointestinal malignancy

Anus,Colon,Esophagus,Liver ,Pancreas,Rectum,Small
intestine (DUODENUM, JEJUNUM, ILEUM),Stomach,
Other gastrointestinall cancer

Be consistent with current clinical landscape, improve transplant
outcome data

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Specify genitourinary malignancy

Bladder,Cervix,Kidney,Ovary,Prostate,Testicle,Uterus,
Other genitourary malignancy

Be consistent with current clinical landscape, improve transplant
outcome data

yes

Specify the new malignancy

Proposed Information Collection Data Element
Response Option(s)

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Page 16 of 19

Response
required if
Additional Sub
Domain
applies

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Specify other new malignancy:

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Rationale for Information Collection Update

Specify CNS malignancy

Glioma,Meningioma,Other CNS malignancy

Be consistent with current clinical landscape, improve transplant
outcome data

open text

Specify other new malignancy:

open text

Date of diagnosis:

YYYY/MM/DD

Date of diagnosis:

YYYY/MM/DD

yes

Was documentation submitted to the
CIBMTR?

No,Yes

Was documentation submitted to the
CIBMTR?
No,Yes

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Was the new malignancy donor / cell
product derived?

No,Not Done,Yes

Was the new malignancy donor / cell
product derived?
No,Not Done,Yes

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Was documentation submitted to the
CIBMTR?

no,yes

Was documentation submitted to the
CIBMTR?
no,yes

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Was documentation submitted to the
CIBMTR? (e.g. pathology report)
No,Yes

Be consistent with current clinical landscape, improve transplant
outcome data

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Was there EBV reactivation in the
blood?

Be consistent with current clinical landscape, improve transplant
outcome data

Addition of Information Requested

Addition of Information Requested

Was the pathology of the tumor EBV
positive?

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Was PTLD confirmed by biopsy?

No,Yes

Be consistent with current clinical landscape, improve transplant
outcome data

Was the pathology of the tumor EBV
positive?
no,yes

no,yes

No,Not Done,Yes

Page 17 of 19

Response
required if
Additional Sub
Domain
applies

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Other method,Qualitative PCR of blood,Quantitative PCR Be consistent with current clinical landscape, improve transplant
How was EBV reactivation diagnosed? of blood
outcome data

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Specify other method:

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Quantitative EBV viral load of blood:
At diagnosis

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Was a quantitative PCR of blood
performed again after diagnosis?

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Highest EBV viral load of blood:

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Was there lymphomatous
involvement?

No,Yes

Be consistent with current clinical landscape, improve transplant
outcome data

Subsequent
Neoplasms

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Specify sites of PTLD involvement
(check all that apply)

Bone marrow,Central nervous system (brain or
cerebrospinal fluid),Liver,Lung,Lymph
node(s),Other,Spleen

Be consistent with current clinical landscape, improve transplant
outcome data

New Malignancy,
Lymphoproliferative
or Myeloproliferative
Disease / Disorder
yes

yes

Addition of Information Requested

Specify other site:

open text

Be consistent with current clinical landscape, improve transplant
outcome data

no

yes

First Name (person completing form):

open text

First Name (person completing form): open text

no

yes

Last Name:

open text

Last Name:

open text

no

yes

E-mail address:

open text

E-mail address:

open text

no

yes

Date:

YYYY/MM/DD

Date:

YYYY/MM/DD

Subsequent
Neoplasms
Subsequent
Neoplasms
Subsequent
Neoplasms
Subsequent
Neoplasms
Subsequent
Neoplasms

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

open text

Rationale for Information Collection Update

Be consistent with current clinical landscape, improve transplant
outcome data

_____ copies/ml
Be consistent with current clinical landscape, improve transplant
outcome data

No,Yes

Be consistent with current clinical landscape, improve transplant
outcome data

______copies/ml

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Be consistent with current clinical landscape, improve transplant
outcome data

Page 18 of 19

Information
Collection
Domain SubType

Information
Collection Domain
Additional Sub
Domain

Response
required if
Additional Sub
Domain
applies

Information
Collection may
be requested Current Information Collection Data
multiple times Element (if applicable)

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Post-Transplant Periodic Inform

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection
Data Element (if applicable)

Proposed Information Collection Data Element
Response Option(s)

Rationale for Information Collection Update

Page 19 of 19