On September 16th, 2016, The The U.S. Department of Health and Human Services issued a final rule that sets forth expanded requirements for registration and results information to ClinicalTrials.gov for FDA-regulated drug, biological, and device products.
Simultaneously, NIH issued a complementary policy requiring registration and results information to ClinicaTrials.gov for all NIH-sponsored clinical trials, regardless of whether the trial is covered by the HHS Final Rule.
Projects Requiring Registration
The following types of clinical trials require registration on ClinicalTrials.gov:
- An NIH funded clinical trial; or
- An FDA regulated clinical trial involving drugs, devices, or biologics.
All other clinical trials (those without NIH funding and those not FDA regulated) are still encouraged to register on ClinicalTrials.gov.
ClinicalTrials.gov Registration Steps
1. Create an Account
- Contact the Protocol Reporting System (PRS) Administrator – Maureen Pelham (firstname.lastname@example.org)
- Log-on to PRS: https://register.clinicaltrials.gov/
- Enter the required and optional data elements
- Assign the “Sponsor” (Florida International University) as the Responsible Party (RP)
- Check for spelling and to see that all acronyms are expanded using the “Spelling” feature
- Check for any “Errors” or “Warnings”
- Have the RP approve and release the record for review by a ClinicalTrials.gov PRS Reviewer
- Submit a complete and timely response to any comments from the ClinicalTrials.gov PRS Reviewer
3. Results Reporting
- Start preparing early as results reporting can be a time-consuming and rigid process
- Enter the required and optional data elements and submit prior to the 12-month timeline
4. Tips, Tricks, and Timelines
- The FDA and NIH require trial registry no later than 21 days after enrollment of the first participant
- ICMJE requires trial registry at or before first patient enrollment as a condition for publication
- Set calendar reminders;
- Records must be updated every 6 months
- If Overall Recruitment Status or completion date changes, then update record within 30 days
- Enter and submit basic results no later than 12 months after the Primary Completion Date
- Contact Maureen Pelham at 305-348-0485 or email@example.com if you have any questions
Frequently Asked Questions