Regulatory & Ethics Consultation

We help troubleshoot common results reporting issues on ClinicalTrials.gov:

  • Review before submission to PRS
  • Help address PRS review comments

 

The ClinicalTrials.gov Regulatory Support Team provides assistance to researchers with ClinicalTrials.gov compliance requirements, Including:

  • Registration
  • Resolving review comments
  • Record maintenance
  • Results reporting

 

Did you know?

  • Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires responsible parties to submit study results of clinical trials to ClinicalTrials.gov.
  • UCSF Clinical Trial Registration & Reporting policy requires all clinical trials to (a) be registered before enrolling the first participant and (b) report results within 12 months of last participant visit in the ClinicalTrials.gov database system, for Applicable Clinical Trials (ACTs). Penalties for noncompliance may include withholding of NIH grant funding for the entire institution and civil monetary penalties of up to $10,000 a day.

 

Request Consultation

This service is free for the entire consultation period.

Related Resources

 

Questions?

Please send comments or questions to CTSI Consultation Services:
Email: [email protected]
 

If you have not been contacted by a member of the consulting team within three business days of submitting your request, please get in touch with us.

About Your Request

Cite CTSI CTSI heavily subsidizes consultations. Any publications that benefit from a consultation should cite the CTSI grant.

By submitting a request, you agree to provide feedback and a short evaluation of our services, providing the titles of manuscripts or grants resulting from your consultation(s) upon request.