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:
- The protection of the rights and well-being of subjects;
- Verification of reported data with source documents;
- Verification as to whether the execution of the study is in accordance with the approved protocol and with the applicable legislation and regulations.
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.