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The Office of Research Participant Advocacy (ORPA) ensures the safety and
welfare of all participants in clinical research studies conducted at the GCRC
while maximally facilitating the research process. The office enhances participant
safety by providing guidance and education to investigators and research personnel
in the area of ethics, research integrity, data and safety monitoring, adverse
event reporting, and Good Clinical Practices (GCPs). This guidance includes
providing practical recommendations and tracking mechanisms for participant
safety, while adhering to federal, state, UCLA, GCRC, and sponsor regulations
and guidelines. The office seeks to attain the highest ethical standards for
participant safety and scientific integrity for all GCRC clinical research studies,
while facilitating accessibility to office services by all investigators.
ORPA is responsible for assuring that all GCRC studies have a Data and Safety
Monitoring Plan (DSMP) in place, and, when appropriate, a Data and Safety Monitoring
Board (DSMB), to monitor protocols. Such plans provide for the specialized review
of enrollment and safety-related data including adverse event reporting. The
Data and Safety Monitoring Program guidelines may be obtained
here.
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