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
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