Registration is required by law for:
- FDA Clinical Trials defined as intervention studies that include drugs, biological products, and medical devices;
- NIH Clinical Trials defined as biomedical and behavioral studies of human subjects;
- Publication of research studies that assigns human subjects to health-related interventions and evaluates their outcomes. Other public registries are also available to meet criteria for ICMJE and WHO; and
- Reimbursement of Medicare claims for items and services in clinical trials that are qualified for coverage.
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
Kay Johnson, R.N., Associate Director
Phone: (323) 865-0457
For Non-Cancer Studies & All Other Requests
Jean Chan, HSC Associate Director
Phone: (323) 442-2825
STEPS TO REGISTER STUDY ON CLINICALTRIALS.GOV
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