1 CTRP Registration Complete Batch Template

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

Attach_5A_CTRP_Registry_Complete_Batch_Template.xls

Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI)

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
Oversight Authority

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.







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 (Summary 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

* Two options for data submission: a) when the XML file for trial submission to ClinicalTrials.gov is required, and b) when an XML file is not required.

* Two options for providing person and organization-related information: a) PO-ID for the person or organization, and b) the set of mandatory attributes for person or organization



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 approprate 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 vaiid value tabs in this spreadsheet.


* Identify each trial uniquely. For example, append your cancer center unique trial identifier to the file name.





6 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.

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 Guide at https://wiki.nci.nih.gov/display/CTRP/Trial+Document+Preparation+for+Batch+Uploads.


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.






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 intstructions provided on the the Batch Trial Upload web page, or consult the user guide at:


https://wiki.nci.nih.gov/x/7qViAw

Sheet 4: Sample Trial Data
Unique Trial Identifier Submission Type NCI Trial Identifier ClinicalTrials.gov XML Required? 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 [Sponsor] Organization Name [Sponsor] Street Address [Sponsor] City [Sponsor] State/Province [Sponsor] Zip/Postal code [Sponsor] Country [Sponsor] Email Address [Sponsor] Phone [Sponsor] TTY [Sponsor] FAX [Sponsor] URL Responsible Party Sponsor Contact Type [Sponsor Contact] Title [Sponsor Contact] Person PO-ID [Sponsor Contact] First Name [Sponsor Contact] Middle Name [Sponsor Contact] Last Name [Sponsor Contact] Street Address [Sponsor Contact] City [Sponsor Contact] State/Province [Sponsor Contact] Zip/Postal code [Sponsor Contact] Country [Sponsor Contact] Email Address [Sponsor Contact] Phone [Sponsor Contact] TTY [Sponsor Contact] FAX [Sponsor Contact] URL [Lead Organization] Organization PO-ID [Lead Organization] Name [Lead Organization] Street Address [Lead Organization] City [Lead Organization] State/Province [Lead Organization] Zip/Postal code [Lead Organization] Country [Lead Organization] Email Address [Lead Organization] Phone [Lead Organization] TTY [Lead Organization] FAX [Lead Organization] URL [Lead Organization] Organization Type [Principal Investigator] Person PO-ID [Principal Investigator] First Name [Principal Investigator] Middle Name [Principal Investigator] Last Name [Principal Investigator] Street Address [Principal Investigator] City [Principal Investigator] State/Province [Principal Investigator] Zip/Postal code [Principal Investigator] Country [Principal Investigator] Email Address [Principal Investigator] Phone [Principal Investigator] TTY [Principal Investigator] FAX [Principal Investigator] URL Summary 4 Funding Category [Summary 4 Funding Sponsor/Source] Organization PO-ID [Summary 4 Funding Sponsor/Source] Organization Name [Summary 4 Funding Sponsor/Source] Street Address [Summary 4 Funding Sponsor/Source] City [Summary 4 Funding Sponsor/Source] State/Province [Summary 4 Funding Sponsor/Source] Zip/Postal code [Summary 4 Funding Sponsor/Source ] Country [Summary 4 Funding Sponsor/Source ] Email Address [Summary 4 Funding Sponsor/Source ] Phone [Summary 4 Funding Sponsor/Source ] TTY [Summary 4 Funding Sponsor/Source ] FAX [Summary 4 Funding Sponsor/Source ] URL 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 IND/IDE Type IND/IDE Number IND/IDE Grantor IND/IDE Holder Type [IND/IDE] NIH Institution [IND/IDE] NCI Division /Program [IND/IDE] Has Expanded Access? [IND/IDE] Expanded Access Status [IND/IDE] Exempt Indicator Oversight Authority Country Oversight Authority Organization Name FDA Regulatory Information Indicator Section 801 Indicator Delayed Posting 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
Yes

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

I

Children's Oncology Group 2115 E Jefferson St Rockville MD 20185 USA [email protected] 222-444-8888


PI
















Gynecologic Oncology Group 100 Main St Fairfax VA 22032 USA [email protected] 222-444-8888


cooperative group 1234












Institutional
NCI 2115 E Jefferson Rockville MD 20852 USA [email protected] 111-111-1111



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








United States Federal Government 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 Yes A1 39938 1234 NCT00045
Phase III Study of Zoladex Adjuvant to Radiotherapy in Unfavorable Prognosis Carcinoma of the Prostate Interventional Treatment

III

Radiation Therapy Oncology Group 200 Water Street New York NY 22102 USA [email protected] 222-444-8888


Sponsor Personal
23456













Children's Oncology Group 2115 E Jefferson St Rockville MD 20185 USA [email protected] 222-444-8888


cooperative group
Miljenko B Pilepich 100 Village Hill Lane Natick MA 01760 USA [email protected] 111-111-1112


Institutional
NCI 2115 E Jefferson Rockville MD 20852 USA [email protected] 111-111-1111







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








United States Federal Government No

Yes protocol_document_T1000.doc IRB_Approval_06082007.doc Participating_Sites_T1000_new.xls

Change_memo_doc.doc
2001 O
Yes

12345

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

I
654512










Sponsor Generic Clinical Study Department








[email protected] 240-345-4567



North Central Cancer Treatment Group 100 Meadow Rd Hartford CT 33333 USA [email protected] 222-444-8888


cooperative group 87456












Institutional
NCI 2115 E Jefferson Rockville MD 20852 USA [email protected] 111-111-1111


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








United States Food and Drug Administration Yes Yes No Yes protocol_document_T2001.doc IRB_Approval_T2001.doc Participating_Sites_T2001.xls Informed_Consent_T2001.PDF Other_document_T2001.doc

3000 O
No

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












PI Personal














12345










cooperative group
Jacob J Rowe 100 Old Meadow Rd Houston TX 33323 USA [email protected] 111-111-1114


Institutional
NCI 2115 E Jefferson Rockville MD 20852 USA [email protected] 111-111-1111







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














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

4000 O
Yes

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 Personal

Todd
Wright 400 Main St Handerson TN 20390 USA [email protected] 607-123-1234



Children's Oncology Group 2115 E Jefferson St Rockville MD 20185 USA [email protected] 222-444-8888


cooperative group 45689












Institutional
NCI 2115 E Jefferson Rockville MD 20852 USA [email protected] 111-111-1111







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 No;Yes NA;Approved for marketing Yes;Yes United States Federal Government 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 Generic Director of Clinical Study Department








[email protected] 607-123-1234





























Institutional
NCI 2115 E Jefferson Rockville MD 20852 USA [email protected] 111-111-1111


BR



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








United States Federal Government 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 Lead Organization Type Summary 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 0 ABW AK PI Personal Institution National B01 AA CCR In Review Actual IND CDER Investigator NEI-National Eye Institute Available
O Yes Observational Diagnostic
I AFG AL Sponsor Generic ordering group Externally B08 AE CCT/CTB Approved Anticipated IDE CBER Organization NHLBI-National Heart, Lung, and Blood Institute No longer available
U

Health Service Research
I/II AGO AR

repository Peer-Reviewed B09 AF CTEP Active

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



Other
II AIA AZ

research based Institutional C06 AG DCB Closed to Accrual


NIH NIA-National Institute on Aging Approved for marketing



Prevention
II/III ALB CA

cooperative group
D43 AI DCCPS Closed to Accrual and Intervention


NCI NIAAA-National Institute on Alcohol Abuse and Alcoholism



Screening
III AND CO

cancer center
D71 AM DCEG Temporarily Closed to Accrual



NIAID-National Institute of Allergy and Infectious Diseases



Supportive Care
IV ANT CT

consortium
DP1 AO DTP Temporarily Closed to Accrual and Intervention



NIAMS-National Institute of Arthritis and Musculoskeletal and Skin Diseases



Treatment
NA ARE DE

drug company
DP2 AR DCP Complete



NIBIB-National Institute of Biomedical Imaging and Bioengineering






ARG FL

network
DP3 AT DEA Administratively Complete



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






ARM GA



E11 BC OD Withdrawn



NIDCD-National Institute on Deafness and Other Communication Disorders






ASM HI



F05 BX OSB/SPOREs




NIDCR-National Institute of Dental and Craniofacial Research






ATA IA



F30 CA CIP




NIDDK-National Institute of Diabetes and Digestive and Kidney Diseases






ATF ID



F31 CB CDP




NIDA-National Institute on Drug Abuse






ATG IL



F32 CD TRP




NIEHS-National Institute of Environmental Health Sciences






AUS IN



F33 CE RRP




NIGMS-National Institute of General Medical Sciences






AUT KS



F34 CH N/A




NIMH-National Institute of Mental Health






AZE KY



F37 CI





NINDS-National Institute of Neurological Disorders and Stroke






BDI LA



F38 CK





NINR-National Institute of Nursing Research






BEL MA



G07 CL





NLM-National Library of Medicine






BEN MD



G08 CM





CIT-Center for Information Technology






BFA ME



G11 CN





CSR-Center for Scientific Review






BGD MI



G12 CO





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






BGR MN



G13 CP





NCCAM-National Center for Complementary and Alternative Medicine






BHR MO



G20 CR





NCMHD-National Center on Minority Health and Health Disparities






BHS MS



G94 CT





NCRR-National Center for Research Resources (NCRR






BIH MT



H13 CU





CC-NIH Clinical Center






BLR NC



H23 CX





OD-Office of the Director






BLZ ND



H25 DA













BMU NE



H28 DC













BOL NH



H50 DD













BRA NJ



H57 DE













BRB NM



H62 DK













BRN NV



H64 DP













BTN NY



H75 EB













BVT OH



H79 EH













BWA OK



HD4 EM













CAF OR



HR! EP













CAN PA



I01 ES













CCK RI



K01 EY













CHE SC



K02 FD













CHL SD



K05 GD













CHN TN



K06 GH













CIV TX



K07 GM













CMR UT



K08 GW













COG VA



K12 HB













COK VT



K14 HC













COL WA



K18 HD













COM WI



K21 HG













CPV WV



K22 HI













CRI WY



K23 HK













CUB AB



K24 HL













CXR BC



K25 HM













CYM MB



K26 HO













CYP NB



K30 HP













CZE NL



K99 HR













DEU NS



KD1 HS













DJI NT



KL1 HV













DMA NU



KL2 HX













DNK ON



L30 HY













DOM PE



L32 IP













DZA QC



L40 JT













ECU SK



L50 LM













EGY YT



L60 MD













ERI ACT



M01 MH













ESH NSW



N01 MN













ESP NT



N02 NB













EST QLD



N03 NH













ETH SA



N43 NR













FIN TAS



N44 NS













FJI VIC



P01 NU













FLK WA



P20 OA













FRA




P30 OC













FRO




P40 OD













FSM




P41 OF













FXX




P42 OH













GAB




P50 OL













GBR




P51 OR













GEO




P60 PC













GHA




P76 PH













GIB




PL1 PR













GIN




PN1 PS













GLP




PN2 RC













GMB




R00 RD













GNB




R01 RG













GNQ




R03 RM













GRC




R04 RR













GRD




R06 RX













GRL




R08 SC













GTM




R13 SF













GUF




R15 SH













GUM




R17 SM













GUY




R18 SP













HKG




R21 SU













HMD




R24 TI













HND




R25 TP













HRV




R30 TS













HTI




R33 TW













HUN




R34 VA













IDN




R36 WC













IND




R37 WH













IOT




R41 WT













IRL




R42














IRN




R43














IRQ




R44














ISL




R49














ISR




R55














ITA




R56














JAM




R90














JOR




RC1














JPN




RC2














KAZ




RC3














KEN




RC4














KGZ




RL1














KHM




RL2














KIR




RL5














KNA




RL9














KOR




RS1














KWT




S06














LAO




S10














LBN




S11














LBR




S21














LBY




S22














LCA




SC1














LIE




SC2














LKA




SC3














LSO




T01














LTU




T02














LUX




T03














LVA




T06














MAC




T09














MAR




T14














MCO




T15














MDA




T32














MDG




T34














MDV




T35














MEX




T36














MHL




T37














MKD




T42














MLI




T90














MLT




TL1














MMR




TU2














MNG




U01














MNP




U09














MOZ




U10














MRT




U11














MSR




U13














MTQ




U14














MUS




U17














MWI




U18














MYS




U19














MYT




U1A














NAM




U1Q














NCL




U1S














NER




U1T














NFK




U1V














NGA




U21














NIC




U22














NIU




U23














NLD




U24














NOR




U27














NPL




U2G














NRU




U2R














NZL




U30














OMN




U32














PAK




U34














PAN




U36














PCN




U38














PER




U41














PHL




U42














PLW




U43














PNG




U44














POL




U45














PRI




U47














PRK




U48














PRT




U49














PRY




U50














PYF




U51














QAT




U52














REU




U53














ROM




U54














RUS




U55














RWA




U56














SAU




U57














SDN




U58














SEN




U59














SGP




U60














SGS




U61














SHN




U62














SJM




U65














SLB




U66














SLE




U75














SLV




U79














SMR




U81














SOM




U82














SPM




U83














STP




U84














SUR




U87














SVK




U88














SVN




U90














SWE




UA1














SWZ




UC1














SYC




UC2














SYR




UC3














TCA




UC6














TCD




UC7














TGO




UD1














THA




UE1














TJK




UE2














TKL




UH1














TKM




UH2














TMP




UH3














TON




UL1














TTO




UR1














TUN




UR3














TUR




UR6














TUV




UR8














TWN




US3














TZA




US4














UGA




UT1














UKR




UT2














UMI




VF1














URY




X01














USA




X02














UZB




X06














VAT




X98














VCT




Y01














VEN




Y02














VGB




Z01














VIR




Z02














VNM




















VUT




















WLF




















WSM




















YEM




















YUG




















ZAF




















ZAR




















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 ClinicalTrials.gov XML Required? Yes Yes
Yes, No Indicates whether XML generation for trial submitting in ClinicalTrials.gov is required. If Indicator is assigned to 'No', responsible Party information and Regulatory Information is not required (will be ignored if provided). This value is ignored in update submission
5 Amendment Number



This element is applicable to amendment submission only. Use amendment number that is recorded in user's system.
6 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.
7 Lead Organization Trial Identifier Yes Yes

AS IS in the protocol document & assigned by the lead organization (unique in the lead organization system)
8 NCT



Unique identifier assigned to the published trials in PRS (ClinicalTrials.gov)
9 Other Trial Identifier



If more than one exists, provide them in one column separated with semicolon (;)
10 Title Yes Yes
Max 4000 characters Title from the protocol document
11 Trial Type Yes Yes Yes Interventional, Observational Currently only Interventional trials are accepted
12 Primary Purpose Yes Yes Yes Treatment, Prevention, Supportive Care, Screening, Diagnostic, Health Service Research, Basic Science, Other
13 [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)
14 [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)
15 Phase Yes Yes Yes 0, I, I/II, II, II/III, III, IV, NA,
16 Pilot Trial?


Yes, No Will be recorded only if Phase value is NA. Default: No
17 [Sponsor] Organization PO-ID PO-ID or all mandatory organization attributes are not NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ PO-ID or all mandatory organization attributes are not NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’


18 [Sponsor] Organization Name Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’


19 [Sponsor] Street Address Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’


20 [Sponsor] City Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’


21 [Sponsor] State/Province Yes for US/Canada/Australia Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ and for US/Canada/Australia Yes for US/Canada/Australia Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ and for US/Canada/Australia
2-letter state/province code required for US/Canada, 2-3 letter code required for Australia
22 [Sponsor] Zip/Postal code Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’


23 [Sponsor] Country Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’
3-letter country code required
24 [Sponsor] Email Address Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’ Yes if Sponsor’s PO-ID is NULL AND if ‘ClinicalTrials.gov XML Required?”=’Yes’


25 [Sponsor] Phone



Include Phone Extension if any in the same field. Use XXX-XXX-XXXX format for USA and Canada
26 [Sponsor] TTY




27 [Sponsor] FAX




28 [Sponsor] URL




29 Responsible Party Yes if ClinicalTrials.gov XML Required? is set to 'Yes' Yes if ClinicalTrials.gov XML Required? is set to 'Yes'
PI, Sponsor Ignored if ClinicalTrials.gov XML Required? is set to 'No'
30 Sponsor Contact Type Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party value is Sponsor Personal, Generic Used for defining contact type for the Responsible Party Sponsor (see 27)
31 [Sponsor Contact] Title Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Generic' Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Generic' Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Generic'
Applicable to the Responsible Party=Sponsor Generic Contact only
32 [Sponsor Contact] Person PO-ID Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal'. Sponsor’s Contact PO-ID or all person-specific mandatory attributes must be provided Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal'. Sponsor’s Contact PO-ID or all person-specific mandatory attributes must be provided Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal'. Sponsor’s Contact PO-ID or all person-specific mandatory attributes must be provided

33 [Sponsor Contact] First Name Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL
Applicable to the Responsible Party=Sponsor Personal Contact only
34 [Sponsor Contact] Middle Name



Applicable to the Responsible Party=Sponsor Personal Contact only
35 [Sponsor Contact] Last Name Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL
Applicable to the Responsible Party=Sponsor Personal Contact only
36 [Sponsor Contact] Street Address Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL
Applicable to the Responsible Party=Sponsor Personal Contact only
37 [Sponsor Contact] City Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL
Applicable to the Responsible Party=Sponsor Personal Contact only
38 [Sponsor Contact] State/Province Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL and for USA, Canada or Australia Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL and for USA, Canada or Australia Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL and for USA, Canada or Australia 2-letter state/province code required for US/Canada, 2-3 letter code required for Australia Applicable to the Responsible Party=Sponsor Personal Contact only
39 [Sponsor Contact] Zip/Postal code Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL
Applicable to the Responsible Party=Sponsor Personal Contact only
40 [Sponsor Contact] Country Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' and Sponsor’s Contact PO-ID is NULL 3-letter country code required Applicable to the Responsible Party=Sponsor Personal Contact only
41 [Sponsor Contact] Email Address Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal'

42 [Sponsor Contact] Phone Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal' Yes if ‘ClinicalTrials.gov XML Required?”=’Yes’ and if Responsible Party is Sponsor and Sponsor Contact Type is 'Personal'
Include Phone Extension if any in the same field. Use XXX-XXX-XXXX format for USA and Canada
43 [Sponsor Contact] TTY




44 [Sponsor Contact] FAX




45 [Sponsor Contact] URL




46 [Lead Organization] Organization PO-ID PO-ID or all mandatory organization specific attribute are required PO-ID or all mandatory organization specific attribute are required


47 [Lead Organization] Name Yes if Lead Organization PO-ID is NULL Yes if Lead Organization PO-ID is NULL


48 [Lead Organization] Street Address Yes if Lead Organization PO-ID is NULL Yes if Lead Organization PO-ID is NULL


49 [Lead Organization] City Yes if Lead Organization PO-ID is NULL Yes if Lead Organization PO-ID is NULL


50 [Lead Organization] State/Province Yes for US/Canada/Australia and if Lead Organization PO-ID is NULL Yes for US/Canada/Australia and if Lead Organization PO-ID is NULL
2-letter state/province code required for US/Canada, 2-3 letter code required for Australia
51 [Lead Organization] Zip/Postal code Yes if Lead Organization PO-ID is NULL Yes if Lead Organization PO-ID is NULL


52 [Lead Organization] Country Yes if Lead Organization PO-ID is NULL Yes if Lead Organization PO-ID is NULL
3-letter country code required
53 [Lead Organization] Email Address Yes if Lead Organization PO-ID is NULL Yes if Lead Organization PO-ID is NULL


54 [Lead Organization] Phone



Include Phone Extension if any in the same field. Use XXX-XXX-XXXX format for USA and Canada
55 [Lead Organization] TTY




56 [Lead Organization] FAX




57 [Lead Organization] URL




58 [Lead Organization] Organization Type


Institution, ordering group, repository, research based, cooperative group, cancer center, consortium, drug company, network
59 [Principal Investigator] Person PO-ID PO-ID or all person-specific mandatory attributes PO-ID or all person-specific mandatory attributes


60 [Principal Investigator] First Name Yes if Principal Investigator PO-ID is NULL Yes if Principal Investigator PO-ID is NULL


61 [Principal Investigator] Middle Name




62 [Principal Investigator] Last Name Yes if Principal Investigator PO-ID is NULL Yes if Principal Investigator PO-ID is NULL


63 [Principal Investigator] Street Address Yes if Principal Investigator PO-ID is NULL Yes if Principal Investigator PO-ID is NULL


64 [Principal Investigator] City Yes if Principal Investigator PO-ID is NULL Yes if Principal Investigator PO-ID is NULL


65 [Principal Investigator] State/Province Yes for US/Canada/Australia and if Principal Investigator PO-ID is NULL Yes for US/Canada/Australia and if Principal Investigator PO-ID is NULL
2-letter state/province code required for US/Canada, 2-3 letter code required for Australia
66 [Principal Investigator] Zip/Postal code Yes if Principal Investigator PO-ID is NULL Yes if Principal Investigator PO-ID is NULL


67 [Principal Investigator] Country Yes if Principal Investigator PO-ID is NULL Yes if Principal Investigator PO-ID is NULL
3-letter country code required
68 [Principal Investigator] Email Address Yes if Principal Investigator PO-ID is NULL Yes if Principal Investigator PO-ID is NULL


69 [Principal Investigator] Phone Yes if Principal Investigator PO-ID is NULL Yes if Principal Investigator PO-ID is NULL

Include Phone Extension if any in the same field. Use XXX-XXX-XXXX format for USA and Canada
70 [Principal Investigator] TTY




71 [Principal Investigator] FAX




72 [Principal Investigator] URL




73 Summary 4 Funding Category Yes Yes Yes National, Externally Peer-Reviewed, Institutional
74 [Summary 4 Funding Sponsor/Source] Organization PO-ID PO-ID or all mandatory organization specific attribute are required PO-ID or all mandatory organization specific attribute are required PO-ID or all mandatory organization specific attribute are required
Provide PO-ID or all organization related mandatory attributes
75 [Summary 4 Funding Sponsor/Source] Organization Name Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL
Provide if PO-ID is NULL
76 [Summary 4 Funding Sponsor/Source] Street Address Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL
Provide if PO-ID is NULL
77 [Summary 4 Funding Sponsor/Source] City Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL
Provide if PO-ID is NULL
78 [Summary 4 Funding Sponsor/Source] State/Province Yes if Organization PO-ID is NULL and for US/Canada/Australia Yes if Organization PO-ID is NULL and for US/Canada/Australia Yes if Organization PO-ID is NULL and for US/Canada/Australia
Provide if PO-ID is NULL
79 [Summary 4 Funding Sponsor/Source] Zip/Postal code Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL
Provide if PO-ID is NULL
80 [Summary 4 Funding Sponsor/Source ] Country Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL
Provide if PO-ID is NULL
81 [Summary 4 Funding Sponsor/Source ] Email Address Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL Yes if Organization PO-ID is NULL
Provide if PO-ID is NULL
82 [Summary 4 Funding Sponsor/Source ] Phone



Include Phone Extension if any in the same field. Use XXX-XXX-XXXX format for USA and Canada
83 [Summary 4 Funding Sponsor/Source ] TTY




84 [Summary 4 Funding Sponsor/Source ] FAX




85 [Summary 4 Funding Sponsor/Source ] URL




86 Program Code



Summary 4 element, no LOV exists, codes are specific to cancer centers
87 [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 (;)
88 [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 (;)
89 [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 (;)
90 [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 (;)
91 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.
92 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
93 Current Trial Status Date Yes Yes Yes
Date when the status has came in effect. Format: mm/dd/yyyy
94 Study Start Date Yes Yes Yes
Date that enrollment to the protocol begins. Format: mm/dd/yyyy
95 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.
96 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
97 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.
98 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 (;).
99 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 (;)
100 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 (;)
101 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 (;)
102 [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
103 [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
104 [IND/IDE] Has Expanded Access? Yes if IND/IDE trial Yes if IND/IDE trial Yes if IND/IDE trial Yes, No If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;).
105 [IND/IDE] Expanded Access Status If (Has Expanded Access?) = Yes If (Has Expanded Access?) = Yes If (Has Expanded Access?) = Yes Available, No longer available, Temporarily not available, Approved for marketing 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
106 [IND/IDE] Exempt Indicator Yes

Yes, No If more than one IND/IDE is recorded provide this value for all IND/IDE separated by semicolon (;). Default: 'No'
107 Oversight Authority Country Yes if ClinicalTrials.gov XML Required? is set to 'Yes' Yes if ClinicalTrials.gov XML Required? is set to 'Yes' Yes if ClinicalTrials.gov XML Required? is set to 'Yes' see Oversight Authority tab Ignored if ClinicalTrials.gov XML Required? is set to 'No'
108 Oversight Authority Organization Name Yes ClinicalTrials.gov XML Required? is set to 'Yes' Yes ClinicalTrials.gov XML Required? is set to 'Yes' Yes ClinicalTrials.gov XML Required? is set to 'Yes' see Oversight Authority tab Ignored if ClinicalTrials.gov XML Required? is set to 'No'
109 FDA Regulatory Information Indicator Yes ClinicalTrials.gov XML Required? is set to 'Yes' Yes ClinicalTrials.gov XML Required? is set to 'Yes' Yes ClinicalTrials.gov XML Required? is set to 'Yes' Yes, No Must be 'Yes; if trial includes IND/IDE. Ignored if ClinicalTrials.gov XML Required? is set to 'No'
110 Section 801 Indicator Yes if FDA Regulatory Information Indicator is 'Yes' and ClinicalTrials.gov XML Required? is set to 'Yes' Yes if FDA Regulatory Information Indicator is 'Yes' and ClinicalTrials.gov XML Required? is set to 'Yes' Yes if FDA Regulatory Information Indicator is 'Yes' and ClinicalTrials.gov XML Required? is set to 'Yes' Yes, No Must be not NULL if FDA Regulatory Information Indicator is 'Yes'. Ignored if ClinicalTrials.gov XML Required? is set to 'No'
111 Delayed Posting Indicator Yes if section 801 Indicator is 'Yes' and ClinicalTrials.gov XML Required? is set to 'Yes' Yes if section 801 Indicator is 'Yes' and ClinicalTrials.gov XML Required? is set to 'Yes' Yes if section 801 Indicator is 'Yes' and ClinicalTrials.gov XML Required? is set to 'Yes' Yes, No Must be not NULL if section 801 Indicator is 'Yes'. Delayed Posting Indicator is applicable only to study that includes device intervention. Ignored if ClinicalTrials.gov XML Required? is set to 'No'
112 Data Monitoring Committee Appointed Indicator


Yes, No Ignored if ClinicalTrials.gov XML Required? is set to 'No'
113 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.
114 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.
115 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
116 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).
117 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).
118 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).
119 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
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
COOK ISLANDS COK
COSTA RICA CRI
COTE D'IVOIRE CIV
CROATIA (local name: Hrvatska) HRV
CUBA CUB
CYPRUS CYP
CZECH REPUBLIC CZE
DENMARK DNK
DJIBOUTI DJI
DOMINICA DMA
DOMINICAN REPUBLIC DOM
EAST TIMOR TMP
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
FRANCE, METROPOLITAN FXX
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
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
ISRAEL ISR
ITALY ITA
JAMAICA JAM
JAPAN JPN
JORDAN JOR
KAZAKHSTAN KAZ
KENYA KEN
KIRIBATI KIR
KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF PRK
KOREA, REPUBLIC OF KOR
KUWAIT KWT
KYRGYZSTAN KGZ
LAO PEOPLE'S DEMOCRATIC REPUBLIC LAO
LATVIA LVA
LEBANON LBN
LESOTHO LSO
LIBERIA LBR
LIBYAN ARAB JAMAHIRIYA LBY
LIECHTENSTEIN LIE
LITHUANIA LTU
LUXEMBOURG LUX
MACAU MAC
MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF 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
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
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 ROM
RUSSIAN FEDERATION RUS
RWANDA RWA
SAINT KITTS AND NEVIS KNA
SAINT LUCIA LCA
SAINT VINCENT AND THE GRENADINES VCT
SAMOA WSM
SAN MARINO SMR
SAO TOME AND PRINCIPE STP
SAUDI ARABIA SAU
SENEGAL SEN
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
ST. HELENA SHN
ST. PIERRE AND MIQUELON SPM
SUDAN SDN
SURINAME SUR
SVALBARD AND JAN MAYEN ISLANDS SJM
SWAZILAND SWZ
SWEDEN SWE
SWITZERLAND CHE
SYRIAN ARAB REPUBLIC SYR
TAIWAN, PROVINCE OF CHINA TWN
TAJIKISTAN TJK
TANZANIA, UNITED REPUBLIC OF TZA
THAILAND THA
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
YUGOSLAVIA YUG
ZAIRE ZAR
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: Oversight Authority
Oversight Authority Country Oversight Authority Organization Name
Afghanistan Ministry of Public Health
Algeria Ministry of Health
Argentina Human Research Bioethics Committee
Argentina Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia Department of Health and Ageing Therapeutic Goods Administration
Australia Human Research Ethics Committee
Australia National Health and Medical Research Council
Austria Ethikkommission
Austria Agency for Health and Food Safety
Austria Federal Ministry for Health and Women
Austria Federal Office for Safety in Health Care
Bangladesh Bangladesh Medical Research Council
Bangladesh Directorate of Drug Administration
Bangladesh Ethical Review Committee
Belarus Ministry of Health
Belgium Institutional Review Board
Belgium Directorate general for the protection of Public health: Medicines
Belgium Federal Agency for Medicinal Products and Health Products
Belgium Ministry of Social Affairs, Public Health and the Environment
Belgium The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bolivia Ethics Committee
Bolivia Ministry of Health
Brazil National Health Surveillance Agency
Brazil Ministry of Health
Brazil National Committee of Ethics in Research
Bulgaria Ministry of Health
Bulgaria Bulgarian Drug Agency
Burkina Faso Ministry of Health
Burkina Faso Ministry for Higher Education and Research
Cambodia Ministry of Health
Cameroon Ministry of Public Health
Canada Canadian Institutes of Health Research
Canada Ethics Review Committee
Canada Health Canada
Canada Ministry of Health & Long Term Care, Ontario
Chile Comisi?n Nacional de Investigaci?n Cient?fica y Tecnol?gica
Chile Instituto de Salud Publica de Chile
China Ethics Committee
China Ministry of Health
China State Food and Drug Administration
Colombia INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombia Institutional Review Board
Croatia Minister of Science, Education and Sports
Croatia Ministry of Health and Social Care
Czech Republic Ethics Committee
Czech Republic State Institute for Drug Control
Denmark Danish Dataprotection Agency
Denmark Danish Medicines Agency
Denmark Ethics Committee
Denmark National Board of Health
Denmark The Danish National Committee on Biomedical Research Ethics
Denmark The Ministry of the Interior and Health
Denmark The Regional Committee on Biomedical Research Ethics
Dominican Republic Secretar?a del Estado de Salud P?blica y Asistencia Social (SESPAS)
Ecuador Public Health Ministry
Egypt Institutional Review Board
Egypt Ministry of Health and Population
Estonia The State Agency of Medicine
Ethiopia Ethiopia Science and Technology Commission
Finland Ethics Committee
Finland Ministry of Social Affairs and Health
Finland National Agency for Medicines
France Afssaps - French Health Products Safety Agency
France Direction G?n?rale de la Sant?
France French Data Protection Authority
France Institutional Ethical Committee
France Ministry of Health
France National Consultative Ethics Committee for Health and Life Sciences
Gambia Department of State for Health and Social Welfare
Gambia MRC Ethics Committee
Georgia Ministry of Health
Germany Federal Ministry of Food, Agriculture and Consumer Protection
Germany Federal Ministry of Education and Research
Germany Federal Institute for Drugs and Medical Devices
Germany Ethics Commission
Germany Paul-Ehrlich-Institut
Ghana Committee on Human Research
Ghana Ministry of Health
Greece National Organization of Medicines
Greece Ethics Committee
Greece Ministry of Health and Welfare
Guinea-Bissau Ministry of Health
Hong Kong Joint CUHK-NTEC Clinical Research Ethics Committee
Hong Kong Ethics Committee
Hong Kong Department of Health
Hungary National Institute of Pharmacy
Iceland Ministry of Health and Social Security
Iceland Icelandic Medicines Control Agency
India Science and Engineering Research Council
India Institutional Review Board
India Ministry of Science and Technology
India Ministry of Health
India Department of Atomic Energy
India Drugs Controller General of India
India Indian Council of Medical Research
Ireland Ministry of Health
Ireland Medical Ethics Research Committee
Ireland Irish Medicines Board
Israel Ethics Commission
Israel Ministry of Health
Israel Israeli Health Ministry Pharmaceutical Administration
Israel The Israel National Institute for Health Policy Research and Health Services Research
Italy Ministry of Health
Italy National Monitoring Centre for Clinical Trials - Ministry of Health
Italy Ethics Committee
Italy National Institute of Health
Italy National Bioethics Committee
Italy The Italian Medicines Agency
Jamaica Ministry of Health
Japan Foundation for Biomedical Research and Innovation
Japan Pharmaceuticals and Medical Devices Agency
Japan Ministry of Health, Labor and Welfare
Japan Ministry of Education, Culture, Sports, Science and Technology
Japan Institutional Review Board
Jordan Ethical Committee
Kazakhstan Ethical Commission
Kenya Ethical Reveiw Committee
Kenya Institutional Review Board
Kenya Ministry of Health
Latvia State Agency of Medicines
Lebanon Ministry of Public Health
Lebanon Institutional Review Board
Liechtenstein Control Authority for Medicinal Products
Lithuania Bioethics Committee
Lithuania State Medicine Control Agency - Ministry of Health
Macedonia Ethics Committee
Malawi National Health Sciences Research Committee
Malawi College of Medicine Research and Ethics Committee
Malaysia Ministry of Health
Mali Ministry of Health
Mauritius Ministry of Health and Quality of Life
Mexico National Council of Science and Technology
Mexico Ethics Committee
Mexico Federal Commission for Protection Against Health Risks
Mexico Ministry of Health
Mexico National Institute of Public Health, Health Secretariat
Mexico Federal Commission for Sanitary Risks Protection
Morocco Ministry of Public Health
Mozambique Ministry of Health (MISAU)
Netherlands The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands Dutch Health Care Inspectorate
Netherlands Medical Ethics Review Committee (METC)
Netherlands Medicines Evaluation Board (MEB)
Netherlands Independent Ethics Committee
New Zealand Health Research Council
New Zealand Food Safety Authority
New Zealand Health and Disability Ethics Committees
New Zealand Institutional Review Board
New Zealand Medsafe
Nigeria The National Agency for Food and Drug Administration and Control
Norway Data Inspectorate
Norway The National Committees for Research Ethics in Norway
Norway Norwegian Medicines Agency
Norway Norwegian Institute of Public Health
Norway Directorate for Health and Social Affairs
Norway Norwegian Social Science Data Services
Pakistan Ministry of Health
Pakistan Research Ethics Committee
Panama Ministry of Health
Peru Ethics Committee
Peru Ministry of Health
Peru General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines Bureau of Food and Drugs
Philippines Department of Health
Poland Ministry of Scientific Research and Information Technology
Poland Drug Institute
Poland Ministry of Health
Poland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal Ethics Committee for Clinical Research
Portugal National Pharmacy and Medicines Institute
Portugal Health Ethic Committee
Romania National Medicines Agency
Romania State Institute for Drug Control
Saudi Arabia Research Advisory Council
Saudi Arabia Ministry of Health
Senegal Ministere de la sante
Serbia Ethics Committee
Sierra Leone Ministry of Health and Sanitation
Singapore Health Sciences Authority
Singapore Domain Specific Review Boards
Singapore Clinical Trials & Epidemiology Research Unit (CTERU)
Slovenia Agency for Medicinal Products - Ministry of Health
Slovenia Ministry of Health
South Africa National Health Research Ethics Council
South Africa Medicines Control Council
South Africa Department of Health
Spain Ministry of Health
Spain Spanish Agency of Medicines
Spain Ministry of Health and Consumption
Spain Comit? ?tico de Investigaci?n Cl?nica
Spain Ethics Committee
Sri Lanka Ministry of Healthcare & Nutrition
Sudan Ministry of Health
Sweden Medical Products Agency
Sweden The National Board of Health and Welfare
Sweden Swedish National Council on Medical Ethics
Sweden Regional Ethical Review Board
Sweden Institutional Review Board
Switzerland Ethikkommision
Switzerland Federal Office of Public Health
Switzerland Swissmedic
Switzerland Laws and standards
Taiwan Department of Health
Taiwan National Bureau of Controlled Drugs
Taiwan Institutional Review Board
Tanzania National Institute for Medical Research
Tanzania Food & Drug Administration
Tanzania Ministry of Health
Thailand Ethical Committee
Thailand Khon Kaen University Ethics Committee for Human Research
Thailand Food and Drug Administration
Thailand Ministry of Public Health
Tunisia Office of Pharmacies and Medicines
Tunisia Ministry of Public Health
Turkey Ethics Committee
Turkey Ministry of Health
Uganda Research Ethics Committee
Uganda Ministry of Health
Uganda National Council for Science and Technology
Ukraine State Pharmacological Center - Ministry of Health
Ukraine Ministry of Health
United Arab Emirates General Authority for Health Services for Abu Dhabi
United Arab Emirates Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
United Kingdom Food Standards Agency
United Kingdom Medicines and Healthcare Products Regulatory Agency
United Kingdom Research Ethics Committee
United Kingdom National Health Service
United Kingdom Department of Health
United States Federal Government
United States Institutional Review Board
United States Food and Drug Administration
Zambia Research Ethics Committee
Zambia Ministry of Health
Zimbabwe Medical Research Council
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File TitleCTRP Trial Registration Batch Upload Specification
SubjectCTRP Trial Registration Batch Upload Specification
AuthorBala Nair, ScenPro, Inc
Last Modified ByDavid Loose
File Modified2013-04-03
File Created2007-12-27
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