University of Southern California

Research

ClinicalTrials.gov

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 clinicaltrials.gov for FDA-regulated drug, biological, and device products.  Simultaneously, NIH issued a complementary policy requiring registration and results information to clinicaltrials.gov for all NIH-sponsored clinical trials, regardless of whether the trial is covered by the HHS Final Rule.

Registration is required by law 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

Email:  Victoria.Soto@med.usc.edu

Phone:  (323) 865-0454

For Non-Cancer Studies & All Other Requests

Jean Chan, HSC Associate Director

Email:  jeanbcha@usc.edu

Phone:  (323) 442-2825

Additional Information

Training Resources 

STEPS TO REGISTER STUDY ON CLINICALTRIALS.GOV

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