Clinical Research Compliance Policy
The Office of Clinical Research (OCR) serves as the institutional authority responsible for the governance, oversight, and compliance of all clinical research activities conducted under the auspices of MFA and the George Washington University School of Medicine and Health Sciences (SMHS). MFA, in collaboration with SMHS, jointly established the OCR to ensure the integrity, quality, and regulatory compliance of clinical research and to provide centralized governance and coordination across all participating entities.
The OCR is vested with the authority to develop, promulgate, and maintain policies, procedures, guidance, and standardized documentation governing clinical research practices. In fulfillment of this mandate, the OCR shall: (i) provide institutional oversight, education, and operational guidance for clinical research activities; (ii) advance and sustain a culture of regulatory compliance and research integrity across all domains of clinical research, including human subjects protections, privacy, ethics, and research billing; and (iii) ensure institutional adherence to applicable federal and state laws, regulations, sponsor requirements, and accreditation standards.
All Workforce Members engaged in clinical research are required to comply with OCR-issued policies, procedures, guidance, and forms as published on the OCR website. Adherence to OCR requirements is a condition of conducting clinical research under MFA and SMHS oversight, and noncompliance may result in institutional review, corrective action, or limitations on research activities in accordance with institutional policy.
The OCR shall establish, convene, and administer a Clinical Research Compliance Committee (CRCC), which shall function as an institutional governance body responsible for oversight, monitoring, and advisory support related to clinical research compliance across MFA and SMHS.