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This document outlines the responsibilities of an IRB Administrator, emphasizing the essential knowledge and education required to navigate regulations and guidance documents effectively. It highlights the importance of consistency and efficiency in organizational tasks, including tracking actions and maintaining documentation. The communication aspect focuses on fostering close relationships with study teams and IRB members, along with evaluating processes for quality assurance. This resource serves as a guide for optimizing IRB operations and implementing improvement initiatives.
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IRB Administrator Responsibilities(VA and Affiliate) Lucindia Shouse, MS, CIP Program Analyst PRIDE June 1, 2011
Knowledge/Education • Know and apply the requirements • Regulations • Handbooks • Guidance documents • Educate study teams, IRB members, and staff • IRB processes • Standard Operating Procedures
Organization/Consistency/Efficiency • Make sure everything gets done • Track actions • Electronic system • Spreadsheets • Use templates • IRB correspondence • Meeting minutes
Documentation • Document, document, document (not documented = not done) • Maintain up-to-date policies and procedures • Develop and use IRB tools • Reporting as necessary
Communication/Evaluation • Interaction • Close relationships • Evaluate processes • Quality assurance and quality improvement initiatives