Regulatory Writing is a module offered by the Whiting School's Professional Development Program; it focuses on students, but faculty/staff may also enroll.
The course 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.
The course meets on Tuesdays from 10 to 12:30 p.m. for the first seven weeks of the semester. Students enroll through the registrar (as they do for normal classes).
Course descriptions of PDP modules for spring semester are online.