I am familiar with document types including
- Research documents: protocols, subject consent forms, statistical analysis plans (review only), investigator's brochures, and manuals of operations
- Regulatory documents: study reports, Common Technical Document (CTD) modules 2.5 and 2.7 (clinical summaries and overviews), integrated summaries of safety and efficacy, briefing books, and responses to health authority questions
- Publications: research reports, manuscripts, conference materials (abstracts and posters)
- Scientific and health-related documents for the general public: patient education materials, newsletters, and press releases and articles for the media
- Patient narratives
- Standard operating procedures (SOPs)
- Website content
- Academic theses and dissertations (review and English editing only)
This list is not exhaustive: please ask me about other types of documents. I welcome new challenges!
I am fully conversant with Good Clinical Practice, guidance for research ethics, and guidance for medical publications.