For clinical drug trials and trials where the intention is to obtain CE-labelling of medical equipment, you are obliged to follow Norwegian regulations and the guidelines found in Good Clinical Practice (GCP). For other interventional trials, monitoring is optional. Many choose to follow GCP also when it is not mandatory, because it gives a good quality assurance of the trial and may even make publication easier.
GCP is an international guideline and standard for how to do clinical trials, which among other things requires the trial to be monitored.
Monitoring – in this connection – is an important, external quality assurance of your trial, which is done by a competent person, a monitor.
The monitor will visit your clinic, where the study is done – both before, during and after the study is completed – in order to check certain quality parameters in the study:
- That you have agreements and approvals in place
- That the collected data are in accordance with the information in the patient’s medical chart
- That you have a protocol and procedures describing in a good way what is to be done in the study, and that these documents are being followed
- That clinical supplies and blood samples are stored safely and according to requirements
- That all equipment to be used in the trial is available and calibrated
The monitor’s most important task is to be a resource for the study group; a person to guide and advise you on how to conduct your trial and collect data according to the regulations and GCP.
GCP does not specify how much and how often to monitor a trial, except saying that the monitoring should be adequate. The degree of monitoring will therefore depend on the complexity and risk of your trial, and be decided upon after the risk evaluation. It will all be described in a monitoring plan.