University of Southern California


On September 16th, 2016, The The U.S. Department of Health and Human Services issued a final rule that sets forth expanded requirements for registration and results information to for FDA-regulated drug, biological, and device products.  Simultaneously, NIH issued a complementary policy requiring registration and results information to for all NIH-sponsored clinical trials, regardless of whether the trial is covered by the HHS Final Rule.

USC’s IRB’s Policy further states:

“Registration and results reporting are required for applicable clinical trials; however, allows voluntary reporting of other studies that:

The Responsible Party must generally report results no later than 12 months after the trial completion date. Results must include participant baseline characteristics, participant flow diagram, outcomes, and adverse events. Instructions for submitting results are available at FDA also requires sponsors or investigators to certify compliance with registration when submitting certain applications to the FDA. Form FDA 3674 is used to certify compliance. ”

The text above may be used in NIH applications requiring a statement of USC policy.

Registration is required by law and by USC IRB policy for:

Registration of an applicable clinical trial must be submitted no later than 21 days after enrollment of the first participant, and the data that must be reported includes

Non-compliance of these requirements may result in civil monetary penalties, withholding/recovery of federal funds, and/or withholding of publications. 

Principal Investigators are responsible to register their studies prior to participant enrollment in the Protocol Registration System (PRS).

Contacts to Request a PRS User Account

For Cancer Center Studies

Victoria Soto


Phone:  (323) 865-0432

For Non-Cancer Studies & All Other Requests

Jean Chan, HSC Associate Director


Phone:  (213) 821-7134

Additional Information

Training Resources 



                                                                     (Click to Enlarge)