Office of Sponsored Programs (OSP)

Clinical Trial Registration

The Office of Clinical Research administers the Health Science Center’s ClinicalTrials.Gov Protocol Registration System (PRS).


As a reminder, the Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) requires mandatory registration and results reporting for applicable clinical trials (ACTs) defined as:

  1. Trials of Drugs and Biologics: controlled clinical investigations (other than Phase I investigations) of a product subject to FDA regulation; and
  2. Trials of Devices: controlled trials with health outcomes of devices subject to FDA regulation (other than small feasibility studies) and pediatric post market surveillance.

The Health Science Center Principal Investigator of any investigator-initiated applicable clinical trial (regardless of source of funding) is responsible for registering the trial, maintaining the registration until trial completion, and reporting of results.


The law requires registration of ACTs within 21 days of the first participant’s enrollment into the study. Should an investigator plan to publish findings, the registration of a clinical trial must occur prior to enrollment of the first participant. Results reporting must take place within 12 months of the primary completion date. Noncompliance can result in significant financial penalties.


Helpful information on registration and reporting requirements can be found on the ClinicalTrials.gov site at http://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf.


Presentations with audio and slides relevant to providing data to ClinicalTrials.gov are available at http://prsinfo.clinicaltrials.gov/.


Contact the OCR office at OCRmail@uthscsa.edu or 567-8554 to request PRS user accounts for registration of studies or if you have any questions or concerns related to ClinicalTrials.gov registration and reporting requirements.