2 Attach 5A CTRP Registry Complete Batch Template

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

Attach_5A_CTRP_Registry_Complete_Batch_Template.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 Other Trial Related Document File Name Change Memo Document Name Protocol Highlight Document Name
10 O


53112 NCT000123 123;123-A A Phase I study of Taxol in refractory leukemia in children Interventional Treatment

I

Principal Investigator 1234 Principal Investigator 123
1234 Institutional

F34 AG 72345 CTEP Complete
8/1/2010 2/1/2009 Actual 08/01/10 Actual









Yes



No
Yes protocol_document_T10.doc IRB_Approval.doc Participating_Sites_T10.xls 10_Informed_Consent.PDF 10_Other_document.doc

1000 A NCI-2009-00001 A1 39938 1234 NCT00045
Phase III Study of Zoladex Adjuvant to Radiotherapy in Unfavorable Prognosis Carcinoma of the Prostate Interventional Treatment

III

Sponsor




Institutional





Temporarily Closed to Accrual Accrual target was reached for this phase of the study 8/2/2009 1/2/2009 Actual 10/02/11 Anticipated









Yes



No
Yes protocol_document_T1000.doc IRB_Approval_06082007.doc Participating_Sites_T1000_new.xls

Change_memo_doc.doc
2001 O


12345

A Phase I trial of Ifosfamide and Taxol in refractory Pelvic Malignancies Interventional Treatment

I
654512 Sponsor



87456 Institutional
IM K08;CO6 HV;AO 97521;012345 CTEP;CTEP In Review
8/3/2009 12/3/2010 Anticipated 10/3/2011 Anticipated









Yes



Yes Yes Yes protocol_document_T2001.doc IRB_Approval_T2001.doc Participating_Sites_T2001.xls Informed_Consent_T2001.PDF Other_document_T2001.doc

3000 O


65432

Phase III study of priming with granulocyte-macrophage colony stimulating factor (rhu-gm-csf)and of three induction regimens in adult patients (over 55) with acute non-lymphocytic leukemia Interventional Treatment

III

Principal Investigator 1234 Principal Investigator
12345
Institutional





Approved
8/4/2009 12/4/2010 Anticipated 9/4/2012 Anticipated









Yes






3000_protocol_document.doc 3000_IRB_Approval.doc 3000_Participating_Sites.xls 3000_Informed_Consent.PDF 3000_Other_document.doc

4000 O


1233

Phase III Comparison of Methotrexate, Vinblastine, Doxorubicin, and Cisplatin (MVAC) vs. Doxorubicin and Cisplatin (AC) in Women with Advanced Primary or Recurrent Metastatic Carcinoma of the Uterine Endometrium Interventional Other Other Laboratory NA Yes 87654 Sponsor



45689 Institutional





Administratively Complete Closed prematurely 8/5/2009 1/5/2009 Actual 8/5/2009 Actual

IND;IND 67899;10,264 CDER;CDER NIH;NCI NIA;NA NA;DCP Yes; NCT01234567; Yes



No
Yes 4000_protocol_document.doc 4000_IRB_Approval.doc 4000_Participating_Sites.xls 4000_Informed_Consent.PDF 4000_Other_document.doc

5000 U NCI-2009-00001

12308 NCT009876 321-12 An Open-Labeled, Non-Randomized Phase I Study of Alvocidib (Flavopiridol) Administered with Oxaliplatin and Fluorouracil/Leucovorin in Patients with Advanced Solid Tumors Interventional Treatment

I

Sponsor




Institutional
BR



Approved
8/1/2009 12/1/2010 Anticipated 12/1/2011 Anticipated









Yes



No
Yes







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





















A No Interventional Basic Science Other Early Phase I ABW AK Principal Investigator Personal National B01 AA CCR In Review Actual IND CDER Investigator NEI-National Eye Institute Available
O Yes Observational Diagnostic
I AFG AL Sponsor Generic Externally Peer-Reviewed B08 AE CCT/CTB Approved Anticipated IDE CBER Organization NHLBI-National Heart, Lung, and Blood Institute No longer available
U

Health Services Research
I/II AGO AR Sponsor Investigator
Institutional B09 AF CTEP Active

CDRH Industry NHGRI-National Human Genome Research Institute Temporarily not available



Other
II AIA AZ


C06 AG DCB Closed to Accrual


NIH NIA-National Institute on Aging Approved for marketing



Prevention
II/III ALA CA


D43 AI DCCPS Closed to Accrual and Intervention


NCI NIAAA-National Institute on Alcohol Abuse and Alcoholism



Screening
III ALB CO


D71 AM DCEG Temporarily Closed to Accrual



NIAID-National Institute of Allergy and Infectious Diseases



Supportive Care
IV AND CT


DP1 AO DTP Temporarily Closed to Accrual and Intervention



NIAMS-National Institute of Arthritis and Musculoskeletal and Skin Diseases



Treatment
NA ANT DE


DP2 AR DCP Complete



NIBIB-National Institute of Biomedical Imaging and Bioengineering






ARE FL


DP3 AT DEA Administratively Complete



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






ARG GA


E11 BC OD Withdrawn



NIDCD-National Institute on Deafness and Other Communication Disorders






ARM HI


F05 BX OSB/SPOREs




NIDCR-National Institute of Dental and Craniofacial Research






ASM IA


F30 CA CIP




NIDDK-National Institute of Diabetes and Digestive and Kidney Diseases






ATA ID


F31 CB CDP




NIDA-National Institute on Drug Abuse






ATF IL


F32 CD TRP




NIEHS-National Institute of Environmental Health Sciences






ATG IN


F33 CE RRP




NIGMS-National Institute of General Medical Sciences






AUS KS


F34 CH N/A




NIMH-National Institute of Mental Health






AUT KY


F37 CI





NINDS-National Institute of Neurological Disorders and Stroke






AZE LA


F38 CK





NINR-National Institute of Nursing Research






BDI MA


G07 CL





NLM-National Library of Medicine






BEL MD


G08 CM





CIT-Center for Information Technology






BEN ME


G11 CN





CSR-Center for Scientific Review






BFA MI


G12 CO





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






BGD MN


G13 CP





NCCAM-National Center for Complementary and Alternative Medicine






BGR MO


G20 CR





NCMHD-National Center on Minority Health and Health Disparities






BHR MS


G94 CT





NCRR-National Center for Research Resources (NCRR






BHS MT


H13 CU





CC-NIH Clinical Center






BIH NC


H23 CX





OD-Office of the Director






BLM ND


H25 DA













BLR NE


H28 DC













BLZ NH


H50 DD













BMU NJ


H57 DE













BOL NM


H62 DK













BRA NV


H64 DP













BRB NY


H75 EB













BRN OH


H79 EH













BTN OK


HD4 EM













BVT OR


HR! EP













BWA PA


I01 ES













CAF RI


K01 EY













CAN SC


K02 FD













CCK SD


K05 GD













CHE TN


K06 GH













CHL TX


K07 GM













CHN UT


K08 GW













CIV VA


K12 HB













CMR VT


K14 HC













COD WA


K18 HD













COG WI


K21 HG













COK WV


K22 HI













COL WY


K23 HK













COM AB


K24 HL













CPV BC


K25 HM













CRI MB


K26 HO













CUB NB


K30 HP













CXR NL


K99 HR













CYM NS


KD1 HS













CYP NT


KL1 HV













CZE NU


KL2 HX













DEU ON


L30 HY













DJI PE


L32 IP













DMA QC


L40 JT













DNK SK


L50 LM













DOM YT


L60 MD













DZA ACT


M01 MH













ECU NSW


N01 MN













EGY NT


N02 NB













ERI QLD


N03 NH













ESH SA


N43 NR













ESP TAS


N44 NS













EST VIC


P01 NU













ETH WA


P20 OA













FIN



P30 OC













FJI



P40 OD













FLK



P41 OF













FRA



P42 OH













FRO



P50 OL













FSM



P51 OR













GAB



P60 PC













GBR



P76 PH













GEO



PL1 PR













GGY



PN1 PS













GHA



PN2 RC













GIB



R00 RD













GIN



R01 RG













GLP



R03 RM













GMB



R04 RR













GNB



R06 RX













GNQ



R08 SC













GRC



R13 SF













GRD



R15 SH













GRL



R17 SM













GTM



R18 SP













GUF



R21 SU













GUM



R24 TI













GUY



R25 TP













HKG



R30 TS













HMD



R33 TW













HND



R34 VA













HRV



R36 WC













HTI



R37 WH













HUN



R41 WT













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














SAU



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












































File Typeapplication/vnd.openxmlformats-officedocument.spreadsheetml.sheet
File Modified0000-00-00
File Created0000-00-00

© 2024 OMB.report | Privacy Policy