Document Types

I have experience with document types including

  • Publications: manuscripts, abstracts, and posters
  • Clinical research documents: study protocols, subject consent forms, statistical analysis plans (review only), investigator's brochures (IBs), and manuals of operations
  • Regulatory documents: clinical study reports, investigational medicinal product dossiers (IMPDs), 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
  • Patient narratives
  • Documents for patients and the general public: patient education materials, newsletters, and articles for the media
  • Academic theses and dissertations (editorial support only)
  • Funding applications for research
  • Website content

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 and other guidance for research ethics, as well as International Council for Harmonisation (ICH) document guidelines and guidance for medical publications.