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.
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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)

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