In accordance with guidelines from the Radboud UMC, monitoring is mandatory for all WMO-related research. The sponsor (principal investigator) is responsible for organizing this.
 
The monitoring intensity is determined based on the risk level of the research (negligible, moderate, high risk). The research protocol must be accompanied by a monitoring plan, or contain a monitoring plan in which all details relating to the monitoring of a study are recorded.

The purpose of monitoring is:

  1. The protection of the rights and well-being of subjects;
  2. Verification of reported data with source documents;
  3. Verification as to whether the execution of the study is in accordance with the approved protocol and with the applicable legislation and regulations.
Experienced monitors within the Radboudumc Technology Center (RTC) Clinical Studies can support you in all aspects of the monitoring process and will always follow the applicable international laws and regulations, including GCP guidelines.

The RTC Clinical Studies also issues research monitor accounts for external employees. This gives them the opportunity to carry out visits within the Radboudumc, whereby access is only granted to the data of those research subjects to be monitored.


Further information? Contact the RTC Clinical Studies via email or tel: +31 (0) 24 366 83 33.