Technical Writing in Clinical Research

GMS BT 210

This course introduces students to the structure, content, and regulatory requirements of documents created for the clinical research industry. Students review the FDA regulations and ICH guidances for drug, device and biologic documents, AMA Manual of Style Guidelines, and common industry standards. Students also learn to compose study abstracts, clinical protocols, informed consent forms, and clinical study reports.

Note: this course is also offered during Summer Term

Note that this information may change at any time. Please visit the Student Link for the most up-to-date course information.