Basics of Quality Management in CT

4. Monitoring

4.2. Monitoring During The Trial: Monitoring Visits (often many visits at each centre)

Monitoring during the trial: Monitoring visits (often many visits at each centre)


  • To check and document that the trial is being conducted as planned.
Examples of activities

  • Have all patients signed the Informed Consent Form?
  • Have all patients been registered on an ID-list and allocated a unique trial number?
  • If a blinded trial, has the blinding of trial medicine been compromised?
  • Have all patients received the correct trial medicine?
  • Have all data been correctly entered into the trial database?
  • Have possible adverse reactions been registered and reported according to the procedures?
  • Have any problems registered at previous monitoring visits been resolved?