Basics of Quality Management in CT
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.
- 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?