ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. Clinical trials are registered with ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS).
The PRS system was created to be compliant with Section 801 of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Public Law 110-85), which requires that “applicable clinical trials” be registered and results of the trials be reported. For the National Institutes of Health definition of “applicable clinical trials,” see this link.
See also information from the following organizations about registering and reporting a clinical trial:
National Institutes of Health (NIH), especially see this section on Certification Requirements for the NIH and FDA.
Protocol Record Access
As noted above, clinical trial records are registered and updated using the Protocol Registration and Results System (PRS). An individual log-in can be requested by completing the PRS Administrator Contact Request form.
Registration and Results Reporting
Noncompliance may lead to civil monetary penalties: The rules governing clinicaltrials.gov registration and results reporting are based on Federal law.
Principal Investigator (PI) requirements:
Register trials. Register no later than 21 days after enrolling the first subject.
Review and verify clinical trial records. Do this at least every 12 months, but every 6 months is recommended.
Additional reporting. For example, if there are recruitment changes or adverse events or when a trial enrolls its final participant.
Posting of study results. These must be posted no later than 12 months from the date the study is completed. This date, called the “Primary Completion Date,” is entered at the time of initial registration.
If you have general questions about registering and updating a trial, please contact the NFFRE administrator at VHANFLNFFREAdmin@va.gov.
If you are not sure whether or you need to register results, email the PRS directly at email@example.com.