GCP states that ‘monitoring’ is the act of overseeing the progress of a clinical trial and of ensuring that it is conducted, recorded and reported in accordance with the protocol, with GCP and with the applicable regulatory requirements.
Within the monitoring of academic clinical trials, a risk proportionate model to monitoring is recommended. This is already well defined and adapted for clinical trials of investigational medicinal products (see here).
The risk adapted approach has been adopted as many academic clinical trials pose only a minimal additional risk to patient safety as compared to normal clinical practice. This risk-adapted approach to the design and conduct of clinical trials includes monitoring. The type of monitoring to be utilised in a trial depends upon the risks in the particular trial. There are two main approaches to monitoring:
- On-site monitoring
- Central or remote monitoring
A Risk Assessment should be completed at the start of a clinical trial to identify the risks associated with the trial. For each risk identified, mitigation strategies should be implemented to mitigate or manage that risk.
The Risk Assessment will:
- Determine the monitoring strategy for the trial
- Determine a monitoring approach which is proportionate
- Formalise the approach in a monitoring plan
The associated monitoring plan will:
- Be specific to the risks of the trial
- Describe the monitoring strategy
- Detail the monitoring methods to be used and the rationale for them
Who will perform the monitoring?
- On-site monitoring of international sites can be expensive both in terms of financial cost and staff resources.
- At trial set-up when the monitoring plan is being written, consider whether or not it is feasible for a UK-based coordinating centre to visit all international sites in person to perform on-site monitoring.
- Is there a possibility for local institutions to perform monitoring?
- Could the monitoring responsibilities be delegated to an independent team at site or local R&D or CRO if resources are available?
- If English is not the first language of the international site, how will the site be monitored?
- How will monitoring occur at sites where the staff does not speak English?
- Or if the patient notes are not written in English??
Access to patient records and notes
- How will patient records and CRFs be accessed at the time of the monitoring visit?
- Who will organise this access? Can access be limited to just trial patients?
- If there are multiple systems in place for recording of patient data, will monitors have access to all systems?
Access to hospitals
- If the site to be monitored is in a remote area, how will transport to the site be organised?
- UK university staff travelling on university business must register travel plans with the university and must obtain university insurance. Universities may not provide insurance for staff to travel to some collaborating countries. How will monitoring be conducted at these sites?
- Consider the experience of the site to be monitored. Prepare the site in advance for the monitoring visit by explaining the purpose of the visit, the monitoring plan for the visit, discuss the practicalities of the visit.
Timing of un-triggered monitoring visits and costs.
- As the monitoring of international sites may be expensive, consider if the CAPA for any findings could be implemented on-site at the time of the visit.
- Is it possible to combine multiple monitoring visits into a single trip? For example, does the site run more than one trial which requires on-site monitoring?
- Could the monitoring visit be used to provide additional site training? Or conduct a site visit at another hospital?