Is your study registered with ClinicalTrials.gov? Federal law, journal publication standards, and National Institutes of Health (NIH) policy require investigators to submit their clinical studies registration and results to a publicly accessible database. The ClinicalTrials.gov Protocol Registration System (PRS) is an online tool that meets these requirements.
ClinicalTrials.gov is a home for information on publicly and privately funded clinical studies on a range of diseases and conditions. It supports improved transparency and reduces duplication of effort by improving public access to information, providing information for clinicians and their patients, and providing researchers with an overview of a specific field of research.
Which trials should be registered at ClinicalTrials.gov?
- Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation
- Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post market surveillance
Failing to register with ClinicalTrials.gov can result in serious repercussions, including the rejection of manuscript submissions to journals, withholding of grant funds, and civil monetary penalties for Principle Investigators and their institutions.
Need help determining whether your study needs to be registered? Not sure where to start? Submit a service request and we will get in touch with you.
Watch a short cartoon by the University of Alabama at Birmingham Center for Clinical and Translational Science about the importance of clinical trials registration and data submission.
Watch a video about clinical trials registration requirements presented by the University of Alabama at Birmingham Center for Clinical and Translational Science.
How should I register my study?
You should register your study at ClinicalTrials.gov before your first research participant is enrolled.
You must submit your study results no later than 12 months after your study is completed. For assistance, please submit a service request.
Andreas Klein, MD
Director, Regulatory Affairs