Prereq: GMS BT 560 GCP or equivalent or consent of program director. This course introduces students to the structure, content, and regulatory requirements of documents created for the clinical research industry. Students learn about FDA regulations and ICH guidelines for drugs and biologics, the AMA Manual of Style, and other common industry standards. Students learn to apply these industry standards to compose clinical research documents such as a clinical study protocol, informed consent form, and clinical study results.

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