Our services

Monitoring

To guarantee the quality of all research within the MUMC+, all WMO required research is Monitored.

According to the ICH-GCP guidelines, it is mandatory to independently Monitor certain types of research with human subjects.

CTCM offers the service of monitoring to investigators. Together with the project team, a plan for Monitoring will be prepared, in which all details regarding the procedures are stated. This plan will be made according to the specific demands of the study and in line with legislation and regulations. Furthermore, the Monitoring plan can be based on the risk classification of the study.

The trained and experienced Monitors will guarantee high quality data control and efficient interaction with the project team. During the Monitoring visits, the following activities will be carried out:

- Giving advice regarding laws and regulations;

- General control of data collection;

- Verification of source documents and CRFs;

- Controlling the compliance of laws and regulations;

- Complying all protocols;

- Checking of informed consents;

- Controlling the Trial Master File and/or Investigator Site File;

- Verifying the reports on adverse events and complications.

A Monitor report and follow-up letter will be sent to the investigator after each visit.

Please contact us via monitoring.ctcm@mumc.nl or via our secretary for more information about this service!