The primary responsibility of the Research Subject Advocate (RSA) program is to provide assurance to the Principal Investigator (PI) of the General Clinical Research Center (GCRC) that appropriate efforts are being made throughout any clinical research activity at the GCRC to protect the participating individuals and to ensure that their safety receives the highest priority.
- Serve as an unbiased observer during the consent process when requested by either the patient/volunteer or investigator.
- Provide information to patients/volunteers participating in Phase I or Phase II clinical trials and other research that is above minimal risk.
- Assist GCRC investigators to formulate, and the GCRC Advisory Committee (GAC) to review, data and safety monitoring plans.
- Assure that GCRC studies are performed in accordance with IRB-approved protocol and monitoring plan.
- Facilitate the reporting of Serious Adverse Events and Conflicts of Interest to appropriate local committees and Federal agencies.
- Provide access to minutes of GAC meetings that relate to the review of monitoring plans upon request of NCRR staff and site visit team members during the GCRC competitive renewal process.
- Assure that GCRC investigators are appropriately trained and remain current on their regulatory and patient safety responsibilities.
- Participate in other relevant activities, such as GAC and Institutional Review Board (IRB) meetings, as determined by the Principal Investigator of the GCRC grant.
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