Course Description:
This 12-week online course was developed for clinical research professionals who already have an understanding of Good Clinical Practice (GCP) and other basic clinical research guidelines. It will build upon the fundamental concepts of clinical research and expand that knowledge into the realm of medical writing. In order to give students as much hands-on experience and personal feedback as possible, the class size will be caped at a maximum of 5 students per term.
Learning Objectives:
Learning Objectives:
This online course will focus on the fundamentals of regulatory medical writing and will dive into the most common regulatory documents seen at the clinical site level.
By the end of the course, you should have a sound understanding of:
Medical communications
The regulations and guidelines surrounding regulatory documentation
Protocol development
Informed consent form (ICF) and informed assent form development
Clinical study report (CSR) development
Investigator Brochure (IB) development
Prerequisites:
At least 1 year of clinical research experience and GCP training certificate. Proof of both will be required.
Course Outline:
Week 1: Introduction to Medical Communications
Week 2: Regulatory Medical Writing
Week 3: The Protocol Part 1
Week 4: The Protocol Part 2
Week 5: The Protocol Part 3
Week 6: The ICF and assent form
Week 7: The Clinical Study Report I
Week 8: The Clinical Study Report II
Week 9: The Clinical Study Report III
Week 10: The Clinical Study Report IV
Week 11: The Investigator Brochure
Week 12: Careers in Regulatory Medical Writing