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Policy Manual: Manual Section: Policy Number: Effective Date: Supersedes: Reviewed Date: I. II. Administration/Operational Administrative RES100004 August 19, 2014, NEW August 19, 2014, TITLE: CLINICAL
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What is clinical research administration?
Clinical research administration involves overseeing the planning, implementation, and coordination of clinical trials to ensure compliance with regulations and ethical standards.
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Principal Investigators, research coordinators, and institutional review boards are typically responsible for filing clinical research administration.
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Clinical research administration forms must be completed accurately with detailed information about the study protocol, participant recruitment, data collection methods, and regulatory compliance.
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The purpose of clinical research administration is to ensure the safety and welfare of research participants, maintain data integrity, and comply with regulatory requirements.
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Clinical research administration requires reporting on study protocols, informed consent procedures, adverse events, data management, and regulatory approvals.
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