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Changes to NIH and ClinicalTrials.gov Reporting Requirements

Published on March 12, 2018

Changes to NIH and ClinicalTrials.gov reporting requirements may affect you.

The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information requires submission of results to ClinicalTrials.gov for studies not previously required to submit under the FDA Final Rule. Please see the table below for a summary of these changes and the associated reporting requirements. Changes are noted in ​​BLUE. ​

​Element FDA Final Rule​​ New NIH Policy
​Scope
  • ​Applies to all ​FDA regulated clinical trials (drug, biological, device products, and pediatric post market device surveillance studies under FD&C Act).
  • Does not include Phase 1 studies
​Registration
  • ​​​Must occur within 21 days of enrollment of 1st participant
  • ​Must occur within 21 days of enrollment of 1st participant
Results Reporting​
  • ​​Submission of results information must occur no later than 1 year after the completion date (referred to as the “primary completion date” of the clinical trial, which is defined as the date of final data collection for the primary outcome measure.
  • ​​​Submission of results information must occur no later than 1 year after the completion date (referred to as the “primary completion date” of the clinical trial, which is defined as the date of final data collection for the primary outcome measure.
Potential Consequences ​​​of Non-Compliance 
  • ​If Federally funded, grant funding can be withheld
  • Civil monetary penalties of up to $12,000 per day
  • Record in ClinicalTrials.gov will be marked as non-compliant
  • ​May lead to suspension or termination of grant or contract
  • Can affect future funding decisions
  • Record in ClinicalTrials.gov will be marked as non-compliant
Effective Date​
  • ​​January 18, 2017
  • Compliance date is 90 days from the effective date.
  • ​Effective for all competing application and contract proposals submitted on or after January 18, 2017
Questions?​
  • ​For more information, contact Michelle Jenkerson, Associate Director of the Center for Clinical Studies, at Jenkerson_m@wustl.edu or 314-362-5626.

Steps to Compliance for NIH Awardees: grants.nih.gov/policy/clinical-trials/reporting/steps.htm

​​Is my Study considered a Clinical Trial according to the NIH?​ grants.nih.gov/ct-decision/index.htm