ClinicalTrials.gov Registration

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 clinicaltrials.gov for all NIH-sponsored clinical trials, regardless of whether the trial is covered by the HHS Final Rule.


Projects Requiring Registration

All clinical trials (both funded and unfunded) that fall under the following definition need to be registered on ClinicalTrials.gov:

  • A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.  This includes Phase 1 clinical trials, and trials that do not involve any FDA-regulated products (such as trials involving only behavioral interventions).

Find out if your study falls under the definition of a clinical trial


ClinicalTrials.gov Registration Steps

1. Create an Account

  • Contact the Protocol Reporting System (PRS) Administrator – Maureen Pelham (mpelham@fiu.edu)

2. Registration

  • 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 mpelham@fiu.edu if you have any questions

Frequently Asked Questions

1. Who is the Responsible Party for Registering a Clinical Trial?

Determination of Responsible Party for an FIU record depends on whether the study is subject to FDA regulation.

Not FDA regulated:

  • The Principal Investigator is always the Responsible Party and should be selected from the dropdown box.
  • Leave Sponsor as the default Florida International University.

FDA regulated:

  • Sponsor: the individual who holds the IND or IDE (if applicable) and initiates a clinical investigation.
  • Investigator: the individual who conducts a clinical investigation (PI).
  • Sponsor-Investigator: Both, as defined above.
    • The Sponsor-Investigator is always the Responsible Party and should be selected from the dropdown box.
    • Note: If the Sponsor and the Investigator are different individuals, please contact mpelham@fiu.edu.

2. Are there Penalties for Failure to Register a Clinical Trial?

Penalties may include civil monetary penalties up to $10,000 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $10,000 per day until resolved.

For federally funded grants, penalties may include the withholding or recovery of grant funds.

For publications, the unregistered trials will not be considered for publication in journals that adhere to ICMJE standards.