Optimising medical writing

Participants will learn the essential skills and techniques required to produce high-quality documents that adhere to regulatory guidelines and standards. Through practical exercises and case studies, participants will explore various types of clinical trial documents, including protocols, informed consent forms, clinical study reports, and regulatory submissions. The course will also cover effective communication strategies, ethical considerations, and the role of medical writers in supporting the clinical trial process.

• Introduction to Clinical Trial Medical Writing
• Regulatory Requirements and Guidelines for Document Preparation
• Writing Protocols and Informed Consent Forms
• Clinical Study Report (CSR) Writing and Structure
• Investigator's Brochure (IB) Development
• Patient Recruitment Materials and Participant Information Sheets
• Publication Planning and Manuscript Preparation
• Adverse Event Reporting and Safety Narratives
• Writing for Regulatory Submissions (e.g., IND, NDA, MAA)