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Nov 21, 2024
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2021-2022 Course Catalog and Student Handbook [ARCHIVED CATALOG]
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BTEC 1105 - Clinical Regulatory Procedures I
Prerequisite: Program Admission;
Corequisite: BTEC 1100
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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