Document Types

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.