Biobanking for Precision Medicine Seminar Series

Dr. Shannon McCall: Next Generation Biobanking: Operational and Regulatory Requirements for Reporting Results Clinically

February 16, 2022

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Abstract: During this talk, Dr. McCall will briefly review the creation and goals of the Clinical Laboratory Improvement Amendments of 1988 as well as the relevant definitions pertaining to reporting laboratory testing results clinically. She will discuss the pathways for obtaining a CLIA certificate and the spectrum of translational and clinical research activities in this context with an emphasis on tissue-based laboratory testing. The talk will conclude with operational and regulatory requirements invoked by specific activities and project goals concerning research.