Basics of Quality Management in CT

Monitoring after the trial: Close-out visit (one visit 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?
  

One of the duties of a monitor is to write a monitoring report after each visit. This report describes what has been checked, and what follow-up needs to be done and by whom. The report is always sent to the sponsor of the trial who has the overall responsibility of the trial. A copy of the report will be sent to the investigator who is responsible for trial conduct at the centre.

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).