Clinical Development & Research Documents

Clinical Development & Research Documents

  • Research protocols and amendments
  • Informed consent forms
  • Investigators’ brochures (IBs)
  • Investigational medicinal product dossiers (IMPDs)
  • Informed consent forms and patient information leaflets
  • Clinical study reports (full, abbreviated, interim, and synoptic)
  • Patient-level and event-level safety narratives
  • Annotated bibliographies