2 Attach 5A CTRP Registry Complete Batch Template

The Clinical Trials Reporting Program (CTRP) Database (NCI)

Attachment 5a - CTRP_Registry_Complete_Batch_Template 5.10.22 (3).xlsx

Initial Registration

OMB: 0925-0600

Document [xlsx]

Download: xlsx | pdf

Overview

Disclaimer
Readme First
Template Instructions
Sample Trial Data
Trial Data Pick List
Trial Data Element Specs
NIH & NCI Values
NCI Code Definitions
3-letter country code
2-letter state_province
Trial Status Date Diagram

Sheet 1: Disclaimer

Sheet 2: Readme First

CTRP Trial Registration Batch Upload Specification for Complete Trials


About this Document

This document provides you with everything you need to know to upload clinical trial data to the CTRP Trial Registration system, including the following:

Template Instructions
	The Template Instructions worksheet provides detailed instructions for preparing your data and uploading them to the system.

Sample Trial Data
	The Sample Trial Data worksheet provides an example of what a typical batch upload file looks like.
	Note: The worksheet that contains your trial data MUST always be the FIRST worksheet (tab) in the file.

Trial Data Pick List
	The Trial Data Pick List worksheet contains sets of valid values for many of the data elements in the (Sample) Trial Data worksheet.
	The values are displayed in pick lists when you select an appropriate data element cell.
	The pick lists have been provided to assist you in filling out these cells quickly and accurately.
	However, if you prefer, you can type the values instead.
	Note: The drop-down lists will not work if you delete this worksheet.

Trial Data Element Specifications
	The specifications worksheet includes the following information:
	1	Data elements
	2	Order in which the data elements must be presented. The element order is set up for you in columns in the Sample Trial Data tab.
	3	Data element requirements. Requirements differ for original, updated, and amended submissions.
	4	Valid values. The system accepts only those values listed in this document.
	5	Comments. Additional information that helps you to ensure successful upload of your data.

NIH and NCI Values
	The NIH & NCI Values worksheet provides all acceptable values for the following data elements:
	1	Funding Mechanisms
	2	Institute Codes
	3	NCI Division/Program Codes
	4	NIH Institute Codes

NCI Code Definitions
	The NCI Division/Program Code Definitions worksheet lists the long form of each of the division/program acronyms.

Country Codes
	The Country Codes worksheet lists the 3-letter country codes for all countries that submit clinical trial data to the CTRP system.

State and Province Codes
	The State and Province Codes worksheet lists the 2- or 3-letter state/province/territory codes for the United States, Canada, and Australia.

Oversight Authorities
	The Oversight Authorities worksheet lists the names of oversight authorities for all countries that submit clinical trial data to the CTRP system.

Trial Status Date Diagram
	The Trial Status Date diagram illustrates the relationships between trial start dates, primary completion dates, and completion dates.

Sheet 3: Template Instructions

How to Upload Clinical Trial Data to the CTRP Trial Registration System

Before You Begin

Contact the CTRO at [email protected] to request approval for sending batch files to CTRP. Include your login name, first and last names, and email address stored in your CTRP profile.
Note: Once you have received approval, you do not have to request approval for subsequent uploads.

Main Steps for Uploading Your Data

1	Prepare the trial data file.
2	Prepare the trial documents Zip file.
3	Upload your files to the CTRP system via the NCI Trial Registration application batch upload web page at https://trials.nci.nih.gov/registry/admin/batchUpload.action.

Preparing Trial Data Files

1	Ensure that your trial conforms to the supported criteria. This template supports the following:

	*	Interventional trials
	*	Complete (Data Table 4 Funding Sponsor Category is 'National', 'Externally Peer-Reviewed' or 'Institutional') trials submission
	*	Amendments to complete CTRP trials with "Abstraction Verified Response" or "Abstraction Verified No Response" processing statuses
	*	Updates to complete CTRP trials with the processing status "Accepted" and beyond
	*	100 trials per data file
	*	Multiple grants per submitted trial
	*	Multiple IND/IDE per submitted trial
	*	Generic contacts for Responsible Party or Sponsor
	*	Multiple "Other" trial identifiers
			Tip: You can add NCT IDs when updating or amending registered trials.
			Note: You can request a list of CTRP persons and organizations along with PO-IDs from the CTRO at [email protected]. Or, you can use the search organization/person feature in the CTRP Trial Registration application to ascertain PO-IDs.

2	Create a new Excel spreadsheet (.xls) that will contain the mandatory and optional data for the trial(s) as specified in this document.

3	Copy the Sample Trial Data and Trial Data Pick List tabs to your new spreadsheet.
	Most cells on the Sample Trial Data tab for which there are a defined set of valid values have drop-down lists. These allow you to select valid values from a list. The sets of valid values for these drop-down lists are derived from Trial Data Pick List worksheet.

4	Delete the sample data from the Sample Trial Data tab in your new spreadsheet. Optionally, you can rename the tab.

5	Click the cell in which you want to enter data.
	Arrows are displayed whenever a drop-down list is available.
	5a. If arrows are displayed next to the cell, click the arrow and select the appropriate value from the drop-down list.
	5b. If no arrows are displayed, enter the appropriate information using the valid values in this template.

	You must adhere to the following requirements:
	* List trial elements required for registration in the order specified in the Trial Data Element Spec tab in this spreadsheet.
	* Do not change the spelling of data elements or valid values. Changes to spelling or to the order of the trial elements will cause the upload to fail. Similarly, the addition of new/extra trial elements will also cause a failure.
	* Conform to the valid values guidelines when entering trial data. Valid values for each of the trial elements, where applicable, are listed in the Trial Data Element Spec or other valid value tabs in this spreadsheet.
	* Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name.

6	Delete all empty columns that may appear after the last data element column.

7	Delete the Trial Data Pick List worksheet from your new file.

Preparing Trial Document Zip Files

1	Prepare a separate Zip file containing applicable trial documents (e.g. Protocol, IRB approval, Informed Consent, Participating Sites, Change Memo) for the trials in the data file. For trial amendments, you can include either a Change Memo document or Protocol Highlight document. NOTE: The MacOSX native compression utility is not supported.
2	To avoid overwriting existing files when the system extracts your latest upload, rename the document files if they are not unique. For detailed instructions and best practices for file preparation, refer to the CTRP Registration Site User's Guide at https://wiki.nci.nih.gov/x/SwnCBg.
	For example, prefix files with a unique trial identifier such as XXXX_document name.doc.
	If using trial identification prefixes, ensure that each of a given trial's document file names is unique.
3	Provide the document names (including their extensions) in the file containing the trial data. Up to seven (7) files can be specified in one single trial record.
4	Zip all trial-related documents. Do not include pathnames in the Zip files.
	The trial document Zip file that you intend to upload MUST NOT include folders or other Zip files. All trial-related documents must be Word documents ( .doc) or Adobe PDFs (.pdf). No other file types are currently accepted. Zip files created with the MAC OS native compression utility may fail.

	Note: Some elements will be ignored when updating existing CTRP trials via batch upload.


Uploading Your Files

1	Open your browser and navigate to the NCI Trial Registration application batch upload web page at https://trials.nci.nih.gov/registry/admin/batchUpload.action.
2	Follow the instructions provided on the Batch Trial Upload web page. For more comprehensive information, see the CTRP Registration User's Guide at:
	https://wiki.nci.nih.gov/x/Ey0ZCQ

Sheet 4: Sample Trial Data

Unique Trial Identifier

Submission Type

NCI Trial Identifier

Amendment Number

Amendment Date

Lead Organization Trial Identifier

NCT

Other Trial Identifier

Title

Trial Type

Primary Purpose

[Primary Purpose] Additional Qualifier

[Primary Purpose] Other Text

Phase

Pilot Trial?

[Sponsor] Organization PO-ID

Responsible Party

[Responsible Party] Investigator Person PO-ID

[Responsible Party] Title

[Responsible Party] Affiliation Organization PO-ID

[Lead Organization] Organization PO-ID

[Principal Investigator] Person PO-ID

Data Table 4 Funding Category

[Data Table 4 Funding Sponsor/Source] Organization PO-ID

Program Code

[NIH Grant] Funding Mechanism

[NIH Grant] Institute Code

[NIH Grant] Serial Number

[NIH Grant] NCI Division/Program Code

Current Trial Status

Why Study Stopped?

Current Trial Status Date

Study Start Date

Study Start Date Type

Primary Completion Date

Primary Completion Date Type

Study Completion Date

Study Completion Date Type

IND/IDE Type

IND/IDE Number

IND/IDE Grantor

IND/IDE Holder Type

[IND/IDE] NIH Institution

[IND/IDE] NCI Division /Program

[IND/IDE] Availability of Expanded Access?

[IND/IDE] Expanded Access Record

Studies a US FDA regulated Drug Product

Studies a US FDA regulated Device Product

Unapproved/Uncleared Device

Pediatric Post-Market Survelliance

Product Exported from the US

FDA Regulatory Information Indicator

Section 801 Indicator

Data Monitoring Committee Appointed Indicator

Protocol Document File Name

IRB Approval Document File Name

Participating Sites Document File Name

Informed Consent Document File Name

Sheet 5: Trial Data Pick List

Submission Type

Yes_No

Trial Type

Primary Purpose

Primary Purpose Additional Qualifier

Phase

Country Code

State Code

Responsible Party

Sponsor Contact Type

Data Table 4 Funding Category

NIH Grant Funding Mechanism

NIH Grant Institute Code

NCI Division/Program Code

Current Trial Status

Date Type

IND/IDE Type

IND/IDE Grantor

IND/IDE Holder Type

NIH Institution

IND/IDE Expanded Access Status

Interventional

Basic Science

Other

Early Phase I

ABW

Principal Investigator

Personal

National

B01

CCR

In Review

Actual

IND

CDER

Investigator

NEI-National Eye Institute

Available

Yes

Observational

Diagnostic

AFG

Sponsor

Generic

Externally Peer-Reviewed

B08

CCT/CTB

Approved

Anticipated

IDE

CBER

Organization

NHLBI-National Heart, Lung, and Blood Institute

No longer available

Health Services Research

I/II

AGO

Sponsor Investigator

Institutional

B09

CTEP

Active

CDRH

Industry

NHGRI-National Human Genome Research Institute

Temporarily not available

Other

AIA

C06

DCB

Closed to Accrual

NIH

NIA-National Institute on Aging

Approved for marketing

Prevention

II/III

ALA

D43

DCCPS

Closed to Accrual and Intervention

NCI

NIAAA-National Institute on Alcohol Abuse and Alcoholism

Screening

III

ALB

D71

DCEG

Temporarily Closed to Accrual

NIAID-National Institute of Allergy and Infectious Diseases

Supportive Care

AND

DP1

DTP

Temporarily Closed to Accrual and Intervention

NIAMS-National Institute of Arthritis and Musculoskeletal and Skin Diseases

Treatment

ANT

DP2

DCP

Complete

NIBIB-National Institute of Biomedical Imaging and Bioengineering

ARE

DP3

DEA

Administratively Complete

NICHD-Eunice Kennedy Shriver National Institute of Child Health and Human Development

ARG

E11

Withdrawn

NIDCD-National Institute on Deafness and Other Communication Disorders

ARM

F05

OSB/SPOREs

NIDCR-National Institute of Dental and Craniofacial Research

ASM

F30

CIP

NIDDK-National Institute of Diabetes and Digestive and Kidney Diseases

ATA

F31

CDP

NIDA-National Institute on Drug Abuse

ATF

F32

TRP

NIEHS-National Institute of Environmental Health Sciences

ATG

F33

RRP

NIGMS-National Institute of General Medical Sciences

AUS

F34

N/A

NIMH-National Institute of Mental Health

AUT

F37

NINDS-National Institute of Neurological Disorders and Stroke

AZE

F38

NINR-National Institute of Nursing Research

BDI

G07

NLM-National Library of Medicine

BEL

G08

CIT-Center for Information Technology

BEN

G11

CSR-Center for Scientific Review

BFA

G12

FIC-John E. Fogarty International Center for Advanced Study in the Health Sciences

BGD

G13

NCCAM-National Center for Complementary and Alternative Medicine

BGR

G20

NCMHD-National Center on Minority Health and Health Disparities

BHR

G94

NCRR-National Center for Research Resources (NCRR

BHS

H13

CC-NIH Clinical Center

BIH

H23

OD-Office of the Director

BLM

H25

BLR

H28

BLZ

H50

BMU

H57

BOL

H62

BRA

H64

BRB

H75

BRN

H79

BTN

HD4

BVT

HR!

BWA

I01

CAF

K01

CAN

K02

CCK

K05

CHE

K06

CHL

K07

CHN

K08

CIV

K12

CMR

K14

COD

K18

COG

K21

COK

K22

COL

K23

COM

K24

CPV

K25

CRI

K26

CUB

K30

CXR

K99

CYM

KD1

CYP

KL1

CZE

KL2

DEU

L30

DJI

L32

DMA

L40

DNK

L50

DOM

L60

DZA

ACT

M01

ECU

NSW

N01

EGY

N02

ERI

QLD

N03

ESH

N43

ESP

TAS

N44

EST

VIC

P01

ETH

P20

FIN

P30

FJI

P40

FLK

P41

FRA

P42

FRO

P50

FSM

P51

GAB

P60

GBR

P76

GEO

PL1

GGY

PN1

GHA

PN2

GIB

R00

GIN

R01

GLP

R03

GMB

R04

GNB

R06

GNQ

R08

GRC

R13

GRD

R15

GRL

R17

GTM

R18

GUF

R21

GUM

R24

GUY

R25

HKG

R30

HMD

R33

HND

R34

HRV

R36

HTI

R37

HUN

R41

IDN

R42

IMN

R43

IND

R44

IOT

R49

IRL

R55

IRN

R56

IRQ

R90

ISL

RC1

ISR

RC2

ITA

RC3

JAM

RC4

JEY

RL1

JOR

RL2

JPN

RL5

KAZ

RL9

KEN

RS1

KGZ

S06

KHM

S10

KIR

S11

KNA

S21

KOR

S22

KWT

SC1

LAO

SC2

LBN

SC3

LBR

T01

LBY

T02

LCA

T03

LIE

T06

LKA

T09

LSO

T14

LTU

T15

LUX

T32

LVA

T34

MAC

T35

MAF

T36

MAR

T37

MCO

T42

MDA

T90

MDG

TL1

MDV

TU2

MEX

U01

MHL

U09

MKD

U10

MLI

U11

MLT

U13

MMR

U14

MNE

U17

MNG

U18

MNP

U19

MOZ

U1A

MRT

U1Q

MSR

U1S

MTQ

U1T

MUS

U1V

MWI

U21

MYS

U22

MYT

U23

NAM

U24

NCL

U27

NER

U2G

NFK

U2R

NGA

U30

NIC

U32

NIU

U34

NLD

U36

NOR

U38

NPL

U41

NRU

U42

NZL

U43

OMN

U44

PAK

U45

PAN

U47

PCN

U48

PER

U49

PHL

U50

PLW

U51

PNG

U52

POL

U53

PRI

U54

PRK

U55

PRT

U56

PRY

U57

PSE

U58

PYF

U59

QAT

U60

REU

U61

ROU

U62

RUS

U65

RWA

U66

U75

SDN

U79

SEN

U81

SGP

U82

SGS

U83

SHN

U84

SJM

U87

SLB

U88

SLE

U90

SLV

UA1

SMR

UC1

SOM

UC2

SPM

UC3

SRB

UC6

STP

UC7

SUR

UD1

SVK

UE1

SVN

UE2

SWE

UH1

SWZ

UH2

SYC

UH3

SYR

UL1

TCA

UR1

TCD

UR3

TGO

UR6

THA

UR8

TJK

US3

TKL

US4

TKM

UT1

TLS

UT2

TON

VF1

TTO

X01

TUN

X02

TUR

X06

TUV

X98

TWN

Y01

TZA

Y02

UGA

Z01

UKR

Z02

UMI

URY

USA

UZB

VAT

VCT

VEN

VGB

VIR

VNM

VUT

WLF

WSM

YEM

ZAF

ZMB

ZWE

Sheet 6: Trial Data Element Specs

Trial elements Order	Trial data element	Required for original submission	Required for amendment	Required for update	Valid Values	Comments
1	Unique Trial Identifier	Yes	Yes	Yes
2	Submission Type	Yes	Yes	Yes	O, A, U	O - original submission (including the first submission to CTRP); A - amendment submission to the already published trial in CTRP; U - update to the CTRP trial. Amendment submission can be accepted only if the trial processing status is 'Abstraction Verified Response' or 'Abstraction Verified No Response'. Update can be submitted for trials that have been accepted or have processing status other than 'Submitted' and 'Rejected'. See Processing Status Transition tab for information about trial processing statuses
3	NCI Trial Identifier		Yes	Yes		This element is applicable to amendment submission and update to the CTRP trials only. This is the trial identifier assigned by the CTRP. Amendment can only be accepted for trials that have 'Abstraction Verified Response' or 'Abstraction Verified No Response' processing status in CTRP. Update can be submitted for trials that have 'Accepted' status and above.
4	Amendment Number					This element is applicable to amendment submission only. Use amendment number that is recorded in user's system.
5	Amendment Date		Yes			This element is applicable to amendment submission only. Use date of amendment as documented in the amended protocol document . Format mm/dd/yyyy.
6	Lead Organization Trial Identifier	Yes	Yes			AS IS in the protocol document & assigned by the lead organization (unique in the lead organization system)
7	NCT					Unique identifier assigned to the published trials in PRS (ClinicalTrials.gov)
8	Other Trial Identifier					If more than one exists, provide them in one column separated with semicolon (;)
9	Title	Yes	Yes		Max 4000 characters	Title from the protocol document
10	Trial Type	Yes	Yes	Yes	Interventional, Observational	Currently only Interventional trials are accepted
11	Primary Purpose	Yes	Yes	Yes	Treatment, Prevention, Supportive Care, Screening, Diagnostic, Health Service Research, Basic Science, Other
12	[Primary Purpose] Additional Qualifier	Yes if Primary Purpose is 'Other'	Yes if Primary Purpose is 'Other'	Yes if Primary Purpose is 'Other'	Other	Use value 'Other' if Primary Purpose value is 'Other' (this applies to interventional trials only)
13	[Primary Purpose] Other Text	Yes if Primary Purpose is 'Other'	Yes if Primary Purpose is 'Other'	Yes if Primary Purpose is 'Other'		Provide description if Primary Purpose is 'Other' (col 13)
14	Phase	Yes	Yes	Yes	Early Phase I, I, I/II, II, II/III, III, IV, NA,
15	Pilot Trial?				Yes, No	Will be recorded only if Phase value is NA. Default: No
16	[Sponsor] Organization PO-ID	Yes	Yes
17	Responsible Party				PI, Sponsor, Sponsor Investigator
18	[Responsible Party] Investigator Person PO-ID	Yes if ‘Responsible Party’ is PI or Sponsor Investigator	Yes if ‘Responsible Party’ is PI or Sponsor Investigator	Yes if ‘Responsible Party’ is PI or Sponsor Investigator
19	[Responsible Party] Title	Yes if ‘Responsible Party’ is PI or Sponsor Investigator	Yes if ‘Responsible Party’ is PI or Sponsor Investigator	Yes if ‘Responsible Party’ is PI or Sponsor Investigator
20	[Responsible Party] Affilliation Organization PO-ID	Yes if ‘Responsible Party’ is PI or Sponsor Investigator	Yes if ‘Responsible Party’ is PI or Sponsor Investigator	Yes if ‘Responsible Party’ is PI or Sponsor Investigator
21	[Lead Organization] Organization PO-ID	Yes	Yes
22	[Principal Investigator] Person PO-ID	Yes	Yes
23	Data Table 4 Funding Category	Yes	Yes	Yes	National, Externally Peer-Reviewed, Institutional
24	[Data Table 4 Funding Sponsor/Source] Organization PO-ID	Yes	Yes	Yes
25	Program Code					Data Table 4 element, no LOV exists, codes are specific to cancer centers
26	[NIH Grant] Funding Mechanism	Yes: if NIH grant exists	Yes: if NIH grant exists	Yes: if NIH grant exists	Refer Funding Mechanism in Valid Values worksheet.	If more than one grant is recorded provide this value for all grants separated by semicolon (;)
27	[NIH Grant] Institute Code	Yes: if NIH grant exists	Yes: if NIH grant exists	Yes: if NIH grant exists	Refer Institute Code in Valid Values worksheet.	If more than one grant is recorded provide this value for all grants separated by semicolon (;)
28	[NIH Grant] Serial Number	Yes: if NIH grant exists	Yes: if NIH grant exists	Yes: if NIH grant exists	format: 5 or 6 digits	If more than one grant is recorded provide this value for all grants separated by semicolon (;)
29	[NIH Grant] NCI Division/Program Code	Yes: if NIH grant exists	Yes: if NIH grant exists	Yes: if NIH grant exists	Refer NCI Division/Program Code in Valid Values worksheet. Specify only the code.	Defaults to N/A if not specified. If more than one grant is recorded provide this value for all grants separated by semicolon (;)
30	Current Trial Status	Yes	Yes	Yes	In Review, Approved, Active, Closed to Accrual, Closed to Accrual and Intervention , Temporarily Closed to Accrual, Temporarily Closed to Accrual and Intervention, Complete, Administratively Complete are applicable to original submission, amendment and update. Withdrawn status is only applicable to Update functionality.	1) Trials with current trial status 'Withdrawn' are not accepted for the original submission. 2) Submission of amendment or update to existing study with Completed, Administratively Completed, Withdrawn and Disapproved current trial status are not accepted. 3) Please use 'In Review' status at submission of pre-IRB approved study.
31	Why Study Stopped?	Yes if Current Trial Status is Withdrawn, Temporarily Closed to Accrual, Temporarily Closed to Accrual and Intervention or Administratively Complete	Yes if Current Trial Status is Withdrawn, Temporarily Closed to Accrual, Temporarily Closed to Accrual and Intervention or Administratively Complete	Yes if Current Trial Status is Withdrawn, Temporarily Closed to Accrual, Temporarily Closed to Accrual and Intervention or Administratively Complete		Mandatory if Current Trial Status is Withdrawn, Temporarily Closed to Accrual, Temporarily Closed to Accrual and Intervention or Administratively Complete
32	Current Trial Status Date	Yes	Yes	Yes		Date when the status has came in effect. Format: mm/dd/yyyy
33	Study Start Date	Yes	Yes	Yes		Date that enrollment to the protocol begins. Format: mm/dd/yyyy
34	Study Start Date Type	Yes	Yes	Yes	Actual, Anticipated	Only current/past date (in respect to batch upload date) is accepted for actual type and only future date is accepted for anticipated type. 'Anticipated' type is valid for 'In Review' and 'Approved' and 'Withdrawn' current trial status only. 'Actual' type is valid for any other current trial status besides 'In Review', 'Approved' and 'Withdrawn'. For more information check State-Dates tab in this file.
35	Primary Completion Date	Yes	Yes	Yes		Date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. Format: mm/dd/yyyy
36	Primary Completion Date Type	Yes	Yes	Yes	Actual, Anticipated	Only current/past date (in respect to batch upload date) is accepted for actual type and only future date is accepted for anticipated type. 'Actual' type is valid for 'Administratively Complete' or 'Complete' current trial statuses only. 'Anticipated' type is valid for any other current trial status besides 'Administratively Complete' or 'Complete'. For more information check State-Dates tab in this file.
37	Study Completion Date
38	Study Completion Date Type
39	IND/IDE Type	Yes: if IND/IDE trial	Yes: if IND/IDE trial	Yes: if IND/IDE trial	IND, IDE	If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;).
40	IND/IDE Number	Yes: if IND/IDE trial	Yes: if IND/IDE trial	Yes: if IND/IDE trial		If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;)
41	IND/IDE Grantor	Yes: if IND/IDE trial	Yes: if IND/IDE trial	Yes: if IND/IDE trial	CDER, CBER, CDRH	If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;)
42	IND/IDE Holder Type	Yes: if IND/IDE trial	Yes: if IND/IDE trial	Yes: if IND/IDE trial	Investigator, Organization, Industry, NIH, NCI	If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;)
43	[IND/IDE] NIH Institution	Yes If IND/IDE trial AND (IND/IDE Holder Type) = NIH	Yes If IND/IDE trial AND (IND/IDE Holder Type) = NIH	Yes If IND/IDE trial AND (IND/IDE Holder Type) = NIH	Refer NIH Institution in Valid Values worksheet.	If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;). If NIH institution is not applicable to a single IND/IDE, provide NA as replacement for the value
44	[IND/IDE] NCI Division /Program	Yes if IND/IDE trial AND If (IND/IDE Holder Type) = NCI	Yes if IND/IDE trial AND If (IND/IDE Holder Type) = NCI	Yes if IND/IDE trial AND If (IND/IDE Holder Type) = NCI	Refer NCI Division/Program Code in Valid Values worksheet.	If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;). If NCI division/program is not applicable to a single IND/IDE, provide NA as replacement for the value
45	[IND/IDE] Availability of Expanded Access Expanded Access?	Yes if IND/IDE trial	Yes if IND/IDE trial	Yes if IND/IDE trial	Yes, No, Unknown	If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;).
46	[IND/IDE] Expanded Access Record	If (Has Expanded Access?) = Yes	If (Has Expanded Access?) = Yes	If (Has Expanded Access?) = Yes		If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;). If expanded access is not applicable to a single IND/IDE, provide NA as replacement for the value
47	Studies a US FDA regulated Drug Product				Yes, No,
48	Studies a US FDA regulated Device Product				Yes, No,
49	Unapproved/Uncleared Device				Yes, No,
50	Pediatric Post-Market Survelliance				Yes, No,
51	Product Exported from the US				Yes, No,
52	FDA Regulatory Information Indicator				Yes, No
53	Section 801 Indicator	Yes if FDA Regulatory Information Indicator is 'Yes'	Yes if FDA Regulatory Information Indicator is 'Yes'	Yes if FDA Regulatory Information Indicator is 'Yes'	Yes, No
54	Data Monitoring Committee Appointed Indicator				Yes, No
55	Protocol Document File Name	Yes	Yes			1) Include file extension. 2) If you have at least two files with the same name, rename files (ex. prefix unique trial identifier to document name). 3) Submit amended protocol for amendment submission.
56	IRB Approval Document File Name	Yes	Yes			1) Include file extension. 2) if you have at least two files with the same name, rename files (ex. prefix unique trial identifier to document name). 3) Submit dummy file if IRB approval is not required with the statement 'IRB' approval is not required'. 4) Submit dummy file with the following info: name of Review Board (address, phone, email) and Board Affiliation name in case of pre-IRB approved studies submission. 5) One IRB Approval is only needed.
57	Participating Sites Document File Name					1) Include file extension. 2) f you have at least two files with the same name, rename files (ex. prefix unique trial identifier to document name). 3) Requited if case of multi-site trial and if the participation sites information is not included in the protocol document. 4) If participating site changes (recruitment status, program code) or collaborator's info change occur, submit this document for amendment or update
58	Informed Consent Document File Name					1) Requited if is not included in the protocol document.2) Include file extension. 3) f you have at least two files with the same name, rename files (ex. prefix unique trial identifier to document name).
59	Other Trial Related Document File Name					1) Include file extension. 2) f you have at least two files with the same name, rename files (ex. prefix unique trial identifier to document name).
60	Change Memo Document Name		Yes			1) This element is applicable to the amendment only and includes the changes that occurred in the protocol document due to amendment. 2) Include file extension. 3) f you have at least two files with the same name, rename files (ex. prefix unique trial identifier to document name).
61	Protocol Highlight Document Name					1) This element is applicable to the amendment only and includes the protocol document with highlighted changes from the previous version. 2) Include file extension. 3) f you have at least two files with the same name, rename files (ex. prefix unique trial identifier to document name).

Sheet 7: NIH & NCI Values

NOTE: These are the valid values for the data elements. Although they are presented in vertical format, there is no correlation between the columns.


Funding Mechanism	Institute Code	NCI Division/Program Code	NIH Institution
B01	AA	CCR	NEI-National Eye Institute
B08	AE	CTEP	NHLBI-National Heart, Lung, and Blood Institute
B09	AF	CIP	NHGRI-National Human Genome Research Institute
C06	AG	CDP	NIA-National Institute on Aging
DP1	AI	CCT/CTB	NIAAA-National Institute on Alcohol Abuse and Alcoholism
DP2	AM	DCB	NIAID-National Institute of Allergy and Infectious Diseases
DP3	AO	DCCPS	NIAMS-National Institute of Arthritis and Musculoskeletal and Skin Diseases
D43	AR	DCEG	NIBIB-National Institute of Biomedical Imaging and Bioengineering
D71	AT	DTP	NICHD-Eunice Kennedy Shriver National Institute of Child Health and Human Development
E11	BC	DCP	NIDCD-National Institute on Deafness and Other Communication Disorders
F05	BX	DEA	NIDCR-National Institute of Dental and Craniofacial Research
F30	CA	OD	NIDDK-National Institute of Diabetes and Digestive and Kidney Diseases
F31	CB	OSB/SPOREs	NIDA-National Institute on Drug Abuse
F32	CD	TRP	NIEHS-National Institute of Environmental Health Sciences
F33	CE	RRP	NIGMS-National Institute of General Medical Sciences
F34	CH	N/A	NIMH-National Institute of Mental Health
F37	CI		NINDS-National Institute of Neurological Disorders and Stroke
F38	CK		NINR-National Institute of Nursing Research
G07	CL		NLM-National Library of Medicine
G08	CM		CIT-Center for Information Technology
G11	CN		CSR-Center for Scientific Review
G12	CO		FIC-John E. Fogarty International Center for Advanced Study in the Health Sciences
G13	CP		NCCAM-National Center for Complementary and Alternative Medicine
G20	CR		NCMHD-National Center on Minority Health and Health Disparities
G94	CT		NCRR-National Center for Research Resources (NCRR
HD4	CU		CC-NIH Clinical Center
HR!	CX		OD-Office of the Director
	DA
H13	DC
H23	DD
H25	DE
H28	DK
H50	DP
H57	EB
H62	EH
H64	EM
H75	EP
H79	ES
I01	EY
KD1	FD
KL1	GD
KL2	GH
K01	GM
K02	GW
K05	HB
K06	HC
K07	HD
K08	HG
K12	HI
K14	HK
K18	HL
K21	HM
K22	HO
K23	HP
K24	HR
K25	HS
K26	HV
K30	HX
K99	HY
L30	IP
L32	JT
L40	LM
L50	MD
L60	MH
M01	MN
N01	NB
N02	NH
N03	NR
N43	NS
N44	NU
PL1	OA
PN1	OC
PN2	OD
P01	OF
P20	OH
P30	OL
P40	OR
P41	PC
P42	PH
P50	PR
P51	PS
P60	RD
P76	RX
RC1	SC
RC2	SF
RC3	SH
RC4	SM
RL1	SP
RL2	SU
RL5	TI
RL9	TP
RS1	TS
R00	WH
R01	RC
R03	RG
R04	RM
R06	RR
R08	TW
R13	WT
R15	VA
R17	WC
R18
R21
R24
R25
R30
R33
R34
R36
R37
R41
R42
R43
R44
R49
R55
R56
R90
SC1
SC2
SC3
S06
S10
S11
S21
S22
TL1
TU2
T01
T02
T03
T06
T09
T14
T15
T32
T34
T35
T36
T37
T42
T90
UA1
UC1
UC2
UC3
UC6
UC7
UD1
UE1
UE2
UH1
UH2
UH3
UL1
UR1
UR3
UR6
UR8
US3
US4
UT1
UT2
U01
U09
U10
U11
U13
U14
U17
U18
U19
U1A
U1Q
U1S
U1T
U1V
U21
U22
U23
U24
U27
U2G
U2R
U30
U32
U34
U36
U38
U41
U42
U43
U44
U45
U47
U48
U49
U50
U51
U52
U53
U54
U55
U56
U57
U58
U59
U60
U61
U62
U65
U66
U75
U79
U81
U82
U83
U84
U87
U88
U90
VF1
X01
X02
X06
X98
Y01
Y02
Z01
Z02

Sheet 8: NCI Code Definitions

NCI Division/Program Code	Definition
CCR	Center for Cancer Research
CCT/CTB	Center for Cancer Training / Cancer Training Branch
CTEP	Cancer Therapy Evaluation Program
DCB	Division of Cancer Biology
DCCPS	Division of Cancer Control and Population Sciences
DCEG	Division of Cancer Epidemiology and Genetics
DTP	Developmental Therapeutics Program
DCP	Division of Cancer Prevention
DEA	Division of Extramural Activities
OD	Office of the Director, NCI, NIH
OSB/SPOREs	Organ Systems Branch (OSB) /Specialized Programs of Research Excellence (SPOREs)
CIP	Cancer Imaging Program
CDP	Cancer Diagnosis Program
TRP	Translational Research Program
RRP	Radiation Research Program
N/A	Not applicable

Sheet 9: 3-letter country code

Country	3-letter code
Afghanistan	AFG
Aland Islands	ALA
Albania	ALB
Algeria	DZA
American Samoa	ASM
Andorra	AND
Angola	AGO
Anguilla	AIA
Antarctica	ATA
Antigua And Barbuda	ATG
Argentina	ARG
Armenia	ARM
Aruba	ABW
Australia	AUS
Austria	AUT
Azerbaijan	AZE
Bahamas	BHS
Bahrain	BHR
Bangladesh	BGD
Barbados	BRB
Belarus	BLR
Belgium	BEL
Belize	BLZ
Benin	BEN
Bermuda	BMU
Bhutan	BTN
Bolivia	BOL
Bosnia And Herzegowina	BIH
Botswana	BWA
Bouvet Island	BVT
Brazil	BRA
British Indian Ocean Territory	IOT
Brunei Darussalam	BRN
Bulgaria	BGR
Burkina Faso	BFA
Burundi	BDI
Cambodia	KHM
Cameroon	CMR
Canada	CAN
Cape Verde	CPV
Cayman Islands	CYM
Central African Republic	CAF
Chad	TCD
Chile	CHL
China	CHN
Christmas Island	CXR
Cocos (Keeling) Islands	CCK
Colombia	COL
Comoros	COM
Congo	COG
Congo, Democratic Republic of th	COD
Cook Islands	COK
Costa Rica	CRI
Cote D Ivoire	CIV
Croatia	HRV
Cuba	CUB
Cyprus	CYP
Czech Republic	CZE
Denmark	DNK
Djibouti	DJI
Dominica	DMA
Dominican Republic	DOM
Ecuador	ECU
Egypt	EGY
El Salvador	SLV
Equatorial Guinea	GNQ
Eritrea	ERI
Estonia	EST
Ethiopia	ETH
Falkland Islands (Malvinas)	FLK
Faroe Islands	FRO
Fiji	FJI
Finland	FIN
France	FRA
French Guiana	GUF
French Polynesia	PYF
French Southern Territories	ATF
Gabon	GAB
Gambia	GMB
Georgia	GEO
Germany	DEU
Ghana	GHA
Gibraltar	GIB
Greece	GRC
Greenland	GRL
Grenada	GRD
Guadeloupe	GLP
Guam	GUM
Guatemala	GTM
Guernsey	GGY
Guinea	GIN
Guinea-Bissau	GNB
Guyana	GUY
Haiti	HTI
Heard And Mc Donald Islands	HMD
Holy See (Vatican City State)	VAT
Honduras	HND
Hong Kong	HKG
Hungary	HUN
Iceland	ISL
India	IND
Indonesia	IDN
Iran (Islamic Republic Of)	IRN
Iraq	IRQ
Ireland	IRL
Isle of Man	IMN
Israel	ISR
Italy	ITA
Jamaica	JAM
Japan	JPN
Jersey	JEY
Jordan	JOR
Kazakhstan	KAZ
Kenya	KEN
Kiribati	KIR
Korea, Democratic Peoples Republic of	PRK
Korea, Republic of	KOR
Kuwait	KWT
Kyrgyzstan	KGZ
Lao Peoples Democratic Republic	LAO
Latvia	LVA
Lebanon	LBN
Lesotho	LSO
Liberia	LBR
Libyan Arab Jamahiriya	LBY
Liechtenstein	LIE
Lithuania	LTU
Luxembourg	LUX
Macau	MAC
Macedonia	MKD
Madagascar	MDG
Malawi	MWI
Malaysia	MYS
Maldives	MDV
Mali	MLI
Malta	MLT
Marshall Islands	MHL
Martinique	MTQ
Mauritania	MRT
Mauritius	MUS
Mayotte	MYT
Mexico	MEX
Micronesia, Federated States of	FSM
Moldova, Republic of	MDA
Monaco	MCO
Mongolia	MNG
Montenegro	MNE
Montserrat	MSR
Morocco	MAR
Mozambique	MOZ
Myanmar	MMR
Namibia	NAM
Nauru	NRU
Nepal	NPL
Netherlands	NLD
Netherlands Antilles	ANT
New Caledonia	NCL
New Zealand	NZL
Nicaragua	NIC
Niger	NER
Nigeria	NGA
Niue	NIU
Norfolk Island	NFK
Northern Mariana Islands	MNP
Norway	NOR
Oman	OMN
Pakistan	PAK
Palau	PLW
Palestinian Territory	PSE
Panama	PAN
Papua New Guinea	PNG
Paraguay	PRY
Peru	PER
Philippines	PHL
Pitcairn	PCN
Poland	POL
Portugal	PRT
Puerto Rico	PRI
Qatar	QAT
Reunion	REU
Romania	ROU
Russian Federation	RUS
Rwanda	RWA
Saint Barthelemy	BLM
Saint Helena	SHN
Saint Kitts And Nevis	KNA
Saint Lucia	LCA
Saint Martin (French Part)	MAF
Saint Pierre and Miquelon	SPM
Saint Vincent And The Grenadines	VCT
Samoa	WSM
San Marino	SMR
Sao Tome And Principe	STP
Saudi Arabia	SAU
Senegal	SEN
Serbia	SRB
Seychelles	SYC
Sierra Leone	SLE
Singapore	SGP
Slovakia (Slovak Republic)	SVK
Slovenia	SVN
Solomon Islands	SLB
Somalia	SOM
South Africa	ZAF
South Georgia And The South Sandwich Islands	SGS
Spain	ESP
Sri Lanka	LKA
Sudan	SDN
Suriname	SUR
Svalbard And Jan Mayen Islands	SJM
Swaziland	SWZ
Sweden	SWE
Switzerland	CHE
Syrian Arab Republic	SYR
Taiwan	TWN
Tajikistan	TJK
Tanzania	TZA
Thailand	THA
Timor-Leste	TLS
Togo	TGO
Tokelau	TKL
Tonga	TON
Trinidad And Tobago	TTO
Tunisia	TUN
Turkey	TUR
Turkmenistan	TKM
Turks And Caicos Islands	TCA
Tuvalu	TUV
Uganda	UGA
Ukraine	UKR
United Arab Emirates	ARE
United Kingdom	GBR
United States	USA
United States Minor Outlying Islands	UMI
Uruguay	URY
Uzbekistan	UZB
Vanuatu	VUT
Venezuela	VEN
Viet Nam	VNM
Virgin Islands (British)	VGB
Virgin Islands (U.S.)	VIR
Wallis And Futuna Islands	WLF
Western Sahara	ESH
Yemen	YEM
Zambia	ZMB
Zimbabwe	ZWE

Sheet 10: 2-letter state_province

Country	Country 3-letter code	State/Province	2-3 letter state/province code	Old values
UNITED STATES	USA
		Alabama	AL
		Alaska	AK
		Arizona	AZ
		Arkansas	AR
		California	CA
		Colorado	CO
		Connecticut	CT
		Delaware	DE
		Florida	FL
		Georgia	GA
		Hawaii	HI
		Idaho	ID
		Illinois	IL
		Indiana	IN
		Iowa	IA
		Kansas	KS
		Kentucky	KY
		Louisiana	LA
		Maine	ME
		Maryland	MD
		Massachusetts	MA
		Michigan	MI
		Minnesota	MN
		Mississippi	MS
		Missouri	MO
		Montana	MT
		Nebraska	NE
		Nevada	NV
		New Hampshire	NH
		New Jersey	NJ
		New Mexico	NM
		New York	NY
		North Carolina	NC
		North Dakota	ND
		Ohio	OH
		Oklahoma	OK
		Oregon	OR
		Pennsylvania	PA
		Rhode Island	RI
		South Carolina	SC
		South Dakota	SD
		Tennessee	TN
		Texas	TX
		Utah	UT
		Vermont	VT
		Virginia	VA
		Washington	WA
		West Virginia	WV
		Wisconsin	WI
		Wyoming	WY
CANADA	CAN
		Alberta	AB
		British Columbia	BC
		Manitoba	MB
		New Brunswick	NB
		Newfoundland and Labrador	NL
		Northwest Territories	NT
		Nova Scotia	NS
		Nunavut	NU
		Ontario	ON
		Prince Edward Island	PE
		Quebec	QC
		Saskatchewan	SK
		Yukon	YT
AUSTRALIA	AUT
		Australian Capital Territory	ACT
		New South Wales	NSW
		Northern Territory	NT
		Queensland	QLD
		South Australia	SA
		Tasmania	TAS
		Victoria	VIC
		Western Australia	WA

Sheet 11: Trial Status Date Diagram

Trial Start, Primary Completion, and Completion Dates

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