The ClinicalTrials.gov Protocol Registration and Results System (PRS) is a web-based tool used to submit clinical study information to ClinicalTrials.gov, which is available to the public.

Study registration is required for some FDA-regulated studies, NIH-funded clinical trials, and for publication in over 1,000 journals.

If registration is required, studies approved by the University Park IRB must be registered within 21 days of approval.

All studies approved or determined exempt by the IRB have reporting requirements over the course of study. For a summary of these requirements, see the IRB webpage on after approval activities. For a more detailed description, see the IRB Investigator Manual.