Reporting Results on ClinicalTrials.gov

Results are required to be reported within one year of the Primary Completion Date for:

• A clinical investigation of an FDA-regulated product. Otherwise known as an Applicable Clinical Trial (ACT) or Probable Applicable Clinical Trial (pACT) per FDAAA. (For complete definitions of Applicable Drug and Applicable Device Clinical Trials, see the ACT checklist and FAQs.
• An NIH-funded clinical trial (NIH Clinical Trial Requirements for Grants and Contracts).
• A clinical trial funded by a grant agency that requires results reporting on ClinicalTrials.gov (e.g., PCORI).

For more details on results reporting for ACTs, see FDAAA 801 and the Final Rule: When Do I Need to Submit Results.

For more details on results reporting for NIH-funded clinical trials, see the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information.

• If results information is not submitted to PRS for review by the date results are expected, it will be flagged as Late Results – per FDAAA on ClinicalTrials.gov.
• FDA recently issued Notices of Noncompliance with FDAAA to responsible parties for failure to submit required clinical trial information.
• Non-compliant study records could appear on the FDAAA Trials Tracker website as overdue.
• If results reporting is required per FDAAA, failing to meet the requirement to post summary results within 12 months of the Study Completion Date may incur penalties under the Federal Food, Drug, and Cosmetic Act, including civil monetary penalties or criminal actions.
• If results reporting is required per NIH, failing to meet the requirement to post summary results within 12 months of the Study Completion Date may cause NIH to withhold future grant funding for the institution.

Review the ClinicalTrials.gov Results Reporting Guided Tutorial and the Results Quality Control Review Criteria.

PRS provides Example Studies for Results Data Entry.

For expert help on data analysis, interpretation of results, and other biostatistical issues, request a Biostatistics Consultation from CTSI Consultation Services.

Contact [email protected] for ClinicalTrials.gov help at UCSF, including Results Reporting assistance.

Contact ClinicalTrials.gov PRS at [email protected].