Monitoring
Monitoring ensures that clinical trials are conducted in accordance with the protocol, legislation, and the guidelines set out in Good Clinical Practice (GCP).
If you are conducting a clincial trial involving drugs or medical devices that are to be CE-marked, you as the sponsor or investigator are required to follow both Norwegian legislation and the guidelines set out in Good Clinical Practice (GCP).
GCP is an international guideline and standard for conducting clinical trials, which, among other things, requires that studies be monitored.
Monitoring involves overseeing the progress of a clinical trial and ensuring that it is conducted, documented, and reported in accordance with the protocol, GCP, regulatory requirements, and relevant legislation. Monitoring is legally required in drug trials and studies on medical devices intended for CE marking, and it is an important quality assurance measure by an external competent professional: a monitor. For other interventional studies, monitoring is optional, but many choose to include it as it provides good quality assurance of the study and may facilitate publication.
The monitor visits the department where the study is being conducted – both before, during, and after the trial – to check the following quality parameters:
- All agreements and approvals are in place before the trial starts.
- The data collected in the trial match the information in the patient’s record and other sources.
- Protocol and procedures – ensuring they clearly describe what is to be done in the trial and that they are followed.
- Medications and blood samples – ensuring they are stored safely and in accordance with the requirements.
- Equipment to be used – ensuring it is in place and calibrated.
Types of monitoring visits during the trial:
- Initiation visit before the trial can begin
- Routine monitoring visits during the trial
- Close-out visit
The primary role of the monitor is to act as a resource for you and the trial team; someone who can guide you and provide advice on how best to conduct the trial and collect data in line with the regulations and Good Clinical Practice.
The scope of the monitoring will depend on the complexity and risk of the trial and will be determined after a risk assessment of the trial. This will be described in a monitoring plan.
Monitoring Services from CTU
The Monitoring Section at Oslo University Hospital helps you assess the risks of your project. We have developed a form that addresses most aspects of a clinical trial and everything that could go wrong. We will go through this form together, identify potential risks in the trial, and find solutions to mitigate or eliminate those risks.
Risk management in a clinical trial can be multifaceted: sometimes a procedure that describes how a lab sample should be handled is enough to manage a risk. Other times, good staff training may be necessary. Risks can be reduced or eliminated through effective monitoring, for example, by checking that patients meet the selection criteria for participation in the trial, that the endpoints recorded in the database are correctly transferred and match what is in the medical record, or that the correct patient has been assigned the correct medication.
Physical monitoring visits are outlined in the monitoring plan. Typically, the monitor will visit before trial start, to ensure that all documents are in place in the study binder and that the necessary equipment, procedures, and medications are in place. The monitor will then return for a visit after the first patients have entered the trial. Following that, regular visits, usually once or twice a year, will take place until all patients have completed the trial.
After the monitoring visit, you will receive a report detailing what needs to be corrected and followed up, with a few weeks allowed for you to address any outstanding issues.
Between monitoring visits, the monitor is available for questions and advice on how to conduct the trial and handle any challenges that arise.
The Monitoring Section provides complete, high-quality monitoring services at very favourable prices as part of a regional research support initiative. This means the services are available to all hospitals in South-Eastern Norway. Physical monitoring and the preparation of monitoring plans are invoiced according to the current NorCRIN rates, and this should be factored into the project budget. It is also worth noting that this expense ensures compliance with laws and regulations, enhances the quality of the trial, and can be resource-saving in other areas of the trial implementation.
All other advicing from the Monitoring Section is free of charge.
An overview of our employees can be found here (in Norwegian).