1.5

credits

Average Course Rating

Regulatory writing explores the preparation of clinical documents throughout the life cycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through preparing regulatory submission documents. Clinical documents to be discussed include clinical trial protocols, clinical trial informed consents (ICFs), investigator brochures (IBs), and clinical study reports (CSRs) among others. Essential skills for creating clear and readable documents including basic grammar and usage as well as sentence structure will also be reviewed.