Clinical Trials Registration


January 18, 2017
Mandatory Clinical Trials Registration and Results Reporting –
New Penalties for Non Compliance

GUMC Registration of Clinical Trials

Dear User (Principal Investigator):

New additional registration and results reporting requirements for clinical trials that meet the FDA and/or NIH criteria are listed below.  Registration at is required NO LATER than 21 days after enrolling your first participant.  Studies initiated prior to January 18, 2017, must still comply with existing registration and reporting requirements. Click HERE for more detailed instructions. 

Below you will find the most frequently asked questions of Please read through the material. A reference guide for the PRS can be found at

New England Journal of Medicine – Trial Reporting in – The Final Rule

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