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

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