ClinicalTrials.gov Overview

ClinicalTrials.gov provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions”.

ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). The ClinicalTrials.gov registration requirements were expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA).

FDAAA 801 requires registration of studies meeting the definition of an Applicable Clinical Trial (ACT) on ClinicalTrials.gov. The law also requires the submission of results for ACTs.

In 2016, HHS issued the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), clarifying and expanding the registration and results information submission requirements of FDAAA 801.

The U.S. National Institutes of Health (NIH) issued a final policy establishing the expectation that every clinical trial funded in whole or in part by NIH must be registered on ClinicalTrials.gov and must report results.

UCSF Clinical Trials Registration & Reporting Policy

All Principal Investigators (PIs) conducting Investigator-Initiated Clinical Trials that are initiated and overseen by UCSF faculty, regardless of funding source, must comply with the registration and results reporting requirements in the UCSF Clinical Trials Registration & Reporting Policy. For industry or externally sponsored trials, the industry or external sponsor will generally be responsible for trial registration and results reporting, absent an agreement between the sponsor and the UCSF PI delegating these responsibilities to the UCSF PI.

In January of 2026, the UCSF Clinical Trials Registration & Reporting Policy underwent major revisions. The revised policy contains several updates, including structural changes, revised definitions, clarified roles and responsibilities for principal investigators, sponsors, and other parties, burden-reducing provisions, and defined consequences for noncompliance. 

Please refer to the following resources for more information:

• CTGov Policy 2026 Revision Frequently Asked Questions (FAQ)
• CTGov Policy 2026 Revision Key Changes

Record Registration

All UCSF research meeting the definition of a "Clinical Trial" must be registered on ClinicalTrials.gov before enrolling the first participant per the UCSF Clinical Trials Registration & Reporting Policy. 

UCSF policy defines a Clinical Trial as "any research project that prospectively assigns one or more human subjects to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events."

Exemption: Unfunded research with no intent to publish in an ICMJE journal, that is not otherwise subject to any clinical trial registration requirements (e.g., FDA, NIH, CMS), is exempt from the above provision. Please contact the UCSF ClinicalTrials.gov Regulatory Support Team at [email protected] for guidance.

Record Maintenance

Record Owners are required to update their records within 30 days of a change to Overall Recruitment Status or Completion Dates and at least once every 12 months.

Results Reporting

Results reporting is required no later than 12 months after the Primary Completion Date external site (opens in a new window)  of the trial if a study is:

• 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; or,
• An NIH-funded clinical trial (NIH Clinical Trial Requirements for Grants and Contracts; or,
• Funded by a grant agency that requires results reporting on ClinicalTrials.gov (e.g., PCORI).

If results are not submitted by the date results are expected for ACTs, the record will be flagged as Late Results – per FDAAA on ClinicalTrials.gov and may appear on the FDAAA Trials Tracker website. In addition, the FDA has issued Notices of Noncompliance to responsible parties for failure to submit required clinical trial information. 

Repeated violations of ClinicalTrials.gov regulatory requirements may result in escalation of the non-compliance to UCSF leadership, possible sanctions, and/or disciplinary actions in accordance with University policy and relevant bargaining agreements.