ClinicalTrial.gov Requirements

Both FDAAA (the FDA) and the NIH have similar requirements for studies that are defined as clinical trials under their policies.  Please see the policies below:

• Applicable clinical trials and NIH clinical trials are required to be registered on clinicaltrials.gov within 21 days after the first subjects has been enrolled (with few exceptions).
• Applicable clinical trials and NIH clinical trials are required to be updated at least once every 12 months.
• Applicable clinical trials and NIH clinical trials are required to post results no later than one year after the clinical trial completion date (with few exceptions).

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

The Office of Human Research Protections requires all clinical trials as defined in the Common Rule (45 CFR 46.102(b)) must post a consent form that was used in the trial.  Only one consent form needs to be posted and revised versions do not need to be uploaded. The consent form should only be posted if the actual document had been used to enroll a subject (signed consent forms should not be posted).

Furthermore, the timeline for when the consent form should be posted is between the date that recruitment was closed and 60 days after the last study visit by an enrolled subject as required by the protocol. If the consent form is posted after 60 days after the last study visit, or before recruitment is closed, then the federal requirement to post the consent form is considered unmet.

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

Please do not hesitate to contact the Regulatory Affairs and Clinical Trials Office should you have any questions about these important requirements.