Overview
ClinicalTrials.gov external site (opens in a new window) is a public registry of research studies involving human subjects. ClinicalTrials.gov is the result of a federal law requiring that clinical trials be registered to improve public access to information about clinical research, promote public trust in research, and inform future research.
Background
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) external site (opens in a new window) 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 external site (opens in a new window) (42 CFR Part 11), clarifying and expanding the registration and results information submission requirements of FDAAA 801.
The U.S. National Institutes of Health external site (opens in a new window) (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.
Requirements for Researchers
Registration
All UCSF clinical trials must register on ClinicalTrials.gov before enrolling the first participant per the UCSF Clinical Trials Registration & Reporting Policy external site (opens in a new window) .
Maintenance
Record Owners are required to update their records within 30 days of a change to Overall Recruitment Status external site (opens in a new window) or Completion Dates external site (opens in a new window) 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) 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 external site (opens in a new window) and FAQs external site (opens in a new window) ; or,
- An NIH-funded clinical trial (NIH Clinical Trial Requirements for Grants and Contracts external site (opens in a new window) ; 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 external site (opens in a new window) . In addition, the FDA has issued Notices of Noncompliance external site (opens in a new window) to responsible parties for failure to submit required clinical trial information.