Regulatory Medical Writing: Protocols and Clinical Study Reports

Plan and write the core regulatory documents of drug development: protocols, Investigator’s Brochures, informed consent forms, clinical study reports, narratives and CTD summaries.

Who it’s for

Junior medical writers, clinical research and regulatory professionals, and scientists who want to specialise in regulatory writing for clinical development.

What you’ll be able to do

• Explain where regulatory documents sit in development and the CTD
• Write a clinical trial protocol using ICH E6(R3) and SPIRIT principles
• Prepare Investigator’s Brochures and readable informed consent forms
• Work with statisticians on estimands, analysis sets and statistical analysis plans
• Structure a clinical study report to ICH E3
• Present efficacy and safety results accurately
• Write patient narratives, lay summaries and CTD clinical summaries

What’s included

• 8 in-depth modules, each with a structured lesson
• 8 module quizzes to check your understanding
• Worked examples and a practical exercise in every module
• About 45 hours of study, at your own pace
• Lifetime access, on any device
• Certificate of completion

How you study

Each module combines a structured lesson with a worked example, a practical exercise and key takeaways, followed by a short quiz. You need 70% to pass each quiz and can retake it as often as you like. Complete every module to finish the course.