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Scope/Applicability

Applicable clinical trials of FDA-regulated drug, biological, and device products and pediatric post-market surveillance studies of devices required by the FDA under the FD&C Act.

Does not apply to phase 1 trials or small feasibility device studies.

Applicable clinical trials are (1) clinical trials of drug and biological products that are controlled, clinical investigations, other than phase 1 investigations, of a product subject to FDA regulation; and (2) prospective clinical studies of health outcomes comparing an intervention with a device product against a control in humans (other than small feasibility studies) or any pediatric post-market surveillance studies required by FDA under the FD&C Act.

Applies to public and private sector sponsors and other entities who meet the definition of a responsible party.

All clinical trials funded wholly or partially by NIH.

Includes phase 1 clinical trials and trials that do not involve any FDA regulated product such as trials involving only behavioral interventions.

Applies to NIH-funded clinical trials where applications or proposals are received by NIH on or after the policy’s effective date.

Applies to NIH-conducted clinical trials initiated on or after the policy’s effective date.

Timeframe for registration on ClinicalTrials.gov

Not later than 21 days after enrollment of the first participant.

Same

Registration data elements to be submitted to ClinicalTrials.gov

Elements defined in the final rule. Consists of descriptive information, recruitment information, location and contact information, and administrative data.

Same

Timeframe for results information submission to ClinicalTrials.gov

Not later than 12 months after primary completion date; possible delay of up to an additional 2 years for trials of unapproved products or of products for which initial FDA marketing approval or clearance is being sought, or approval or clearance of  a new use is being sought.

Same

Results information data elements to be submitted to ClinicalTrials.gov

Elements defined in the final rule. Includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol and statistical analysis plan, and administrative information.

Same

Potential Consequences of Noncompliance

• Identifying clinical trial record as non-compliant in ClinicalTrials.gov
• For federally funded trials, grant funding can be withheld if required reporting cannot be verified.
• Civil monetary penalties of up to $10,000/day (amount to be adjusted going forward)

• May lead to suspension or termination of grant or contract funding
• Can be considered in future funding decisions
• Identifying clinical trial record as non-compliant in ClinicalTrials.gov

Effective Date

January 18, 2017. Compliance date is 90 days from the effective date.

January 18, 2017