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Nov 22, 2024
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2021-2022 Course Catalog and Student Handbook [ARCHIVED CATALOG]
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BTEC 2255 - Clinical Regulatory Procedures II
Prerequisite: BTEC 1105
Corequisite: BTEC 1110
This course provides an introduction to Federal, State, and Local regulatory oversight of clinical research on human beings. An examination of the proper conduct of research studies and trial duties for research professionals of all levels. Topics of study include an introduction to clinical research professions, documentation skills, Code of Federal Regulations and Good Clinical Practice, product development, standard operating procedures, Institutional Review
Boards, Informed Consent and Pre-Study preparation. Contact hours: Class - 3, Lab - 0. Credit hours: 3 (F, Sp)
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