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.

​DAIDS ClinicalTrials.gov Protocol Checklist
Version 2.0 - November 2015
This is an interactive form.  For a Section 508 compliant version of this form, please contact the DAIDS RSC at Regulatory@tech-res.com.
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.

For the complete statutory definitions and more detailed information on NIH's current thinking on FDAAA, please visit:

Elaboration of Definitions of Responsible Party and Applicable Clinical Trial 

For additional information on International Committee of Medical Journal Editors (ICMJE), please visit:

International Committee of Medical Journal Editors (ICMJE)

Content last reviewed on 
February 1, 2018