Home / Service / Non-interventional studies / Project preparation /

Non-interventional studies

Project preparation

Study protocol, informed consent, CRF, confirmation of participation

  • Development of documents in form and content up to final layout
  • Review / audit of external documents
  • CRF artwork, production planning and supervision of printing
  • Development of (e)CRF

Authorities / Ethics committee

  • Notification of NIS and participating sites
  • Continuous notification at regular reporting days
  • Preparation and submission of documents to ethics committee
  • Handling of country-specific regulations