Basics of Quality Management in CT
4.3. Monitoring After The Trial: Close-Out Visit (one visit at each centre)
Monitoring after the trial: Close-out visit (one visit at each centre)
- To verify and document that the trial has been closed properly at each centre.
- Have necessary reports been submitted to the authorities?
- Is all trial medicine accounted for?
- Have all questions regarding the data registration been solved?
- Have all lists and reports been signed as necessary?
- Have possible adverse reactions in participants been resolved or minimised?
- Has trial participation been appropriatelly noted in the personal medical records of participating patients?
- Are there any procedures in place for archiving of trial data?
An important part of monitoring a trial is to check whether all trial data have been registered correctly in the trial database. This is done by comparing the data entries in the database with the documents where the trial data was originally recorded (the source data).