4. Monitoring

4.1. Monitoring Before The Trial: Initiation Visit (One Visit At Each Centre)

Monitoring before the trial: Initiation visit (one visit at each centre)

Purpose

  • To check and document that everything is ready for trial initiation at a centre before the first patient is enrolled.
Examples of activities

  • Is the trial approved by relevant authorities?
  • Are all personnel adequately trained?
  • Is the trial medicine on site and properly labelled and stored? • Is relevant rescuing equipment in place in order to guarantee patient safety?
  • Have necessary agreements with other departments been made?
  • Are the forms for data recording ready to use?