NoyMed Academy Certified Medical Writer
Write clinical study reports, protocols, and regulatory documents that hold up under review.
About this program
Regulatory and clinical writing: structure, source discipline, and the review process for submission documents.
Who it is for
Scientists, clinicians, and writers moving into regulatory or clinical medical writing.
Prerequisites
- Strong written English
- Life-sciences degree or equivalent
- Ability to read a clinical study report critically
Curriculum outline
1. The regulatory document set
What gets written and why.
Topics: Protocol and amendments · Investigator's Brochure · CSR (ICH E3) · Common Technical Document overview
2. Protocols and study design writing
Translating design into an operable protocol.
Topics: Objectives and endpoints · Statistical section liaison · Consistency management
3. The clinical study report
Assembling the CSR.
Topics: Results narrative · Working with TLFs · Safety narratives · Appendices
4. Source discipline and quality
Traceability and review.
Topics: Data-to-text traceability · Version control · QC review · Style guides (AMA)
5. Plain language and disclosure
Lay summaries and transparency.
Topics: EU CTR lay summaries · Results disclosure · Readability
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