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. This form will identify which conditions must be met to fulfill requirements set forth by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the NIH Policy on Dissemination of NIH-funded Clinical Trial Information. This form should be submitted along with to-be Version 1.0 main protocol documents at the time of Full Regulatory Review. In addition to the form, a memo from DAIDS describing recent updates to the form can be found below.
DAIDS ClinicalTrials.gov Memorandum
January 2021
DAIDS ClinicalTrials.gov Protocol Checklist
Version 3.0 - August 2020