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DAIDS ClinicalTrials.gov Protocol Checklist

For DAIDS-held IND studies, the responsibility to meet the ClinicalTrials.gov reporting requirements falls within DAIDS. For other studies (e.g., Network Non-IND, non-DAIDS held IND, non​-network non-IND, etc.), the responsibility generally lies with the grantee institution, organization, and/or IND holder.


This form is intended to be filled out electronically for clinical trials involving drugs (including biological products). This form should be submitted along with to-be Version 1.0 main protocol documents at the time of Regulatory Review.


Doc_Icon_PDF DAIDS ClinicalTrials.gov Protocol Checklist
Version 2.0 - November 2015
This document must be viewed using Adobe Acrobat Reader or Adobe Acrobat Pro. Right click on the PDF icon, select "Save link as..." or "Save target as..." from the dropdown menu, and save the PDF.

Contact Information:


For questions about the ClinicalTrials.gov Checklist:
DAIDS ProPEP
Email Email: NIAIDDAIDSClinicalTrialsGov@niaid.nih.gov

DAIDS RSC
Email Email: Regulatory@tech-res.com
Phone Hotline: 1 (301) 897-1706
For the complete statutory definitions and more detailed information on NIH's current thinking on FDAAA, please visit: For additional information on International Committee of Medical Journal Editors (ICMJE), please visit:
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Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).

HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).