UCI Office of Research - Human Research Protections

Institutional Review Board (IRB)

ClinicalTrials.gov Registration & Report Submission

February 6, 2026

If human subject research is subject to ClinicalTrials.gov, registration and submission of results is required.

Where the protocol is investigator initiated and / or the UC Irvine Principal Investigator (PI) holds the Investigational New Drug (IND) the UC Irvine PI is responsible.

A ClinicalTrials.gov Registration Decision Tool is available on the HRP ClinicalTrials.gov webpage. The decision tool combines the registration requirements for Food and Drug Administration (FDA), National Institutes of Health (NIH), and International Committee of Medical Journal Editors (ICMJE). When accessing the tool for the first time, you will be directed to log in with your UCInetID. Use this resource and work closely with HRP colleagues to help determine if your research is subject to ClinicalTrials.gov. There is no need to submit this form.

For those that have registered, PIs must submit results as required. Look at Clinicaltrials.gov or use the FDAAA TrialsTracker to confirm you have submitted results.

If you need an extension, there is a process for that! Requests must be submitted through the Protocol Registration and Results System (PRS) PRIOR to the date of the submission deadline on which clinical trial results information would otherwise be due. There are significant implications to the PI and UC Irvine, if results are not submitted:

Potential Institutional Risks if NOT Submitted as Required
ClinicalTrials.gov

Approximate $15,000 per day penalty against responsible parties who fail to comply with registration and/or results submission requirements
In relation to federally funded studies, withholding of remaining or future grant funds from a grantee for failure to submit clinical trial registration and results information.

Looking ahead, PIs and their Department Chairs will be contacted to address protocols that are overdue. The goal is to address overdue reports PROMPTLY.

Questions?

For any technical difficulties, contact the ERA team at era@research.uci.edu.
For any questions related to ClinicalTrials.gov registration requirements, please:

visit the UCI ClinicalTrials.gov webpage
email the EQUIP team at anuradhm@uci.edu
EQUIP zoom office hours by email request to anuradham@uci.edu

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