This course builds on the knowledge gained in the introductory technical and scientific writing (CRPV110) course.
The course develops advanced medical and technical writing skills necessary to communicate information using real-life practical examples from clinical research, quality assurance, and regulatory affairs departments. Students will further enhance their knowledge of how to write documents such as protocols, informed consent forms, Standard Operating Procedures, and CAPA reports.
Learning Points:
- Advanced Technical and Scientific Writing Tools
- Developing Clinical Study Protocol
- Informed Consent Form (ICF)
- Protocol Deviation Form
- Technical Considerations for Writing Effective CAPA Reports
- Effective Standard Operating Procedures (SOP) Writing and Implementation