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Monitoring should be a helpful and fundamental part of trial conduct. It is not an 'audit' but an ongoing process of working with the trial team to help achieve compliance to the protocol and SOPs. It is there to make sure that the trial is answering the question, that the data is reliable and that good ethical standards are being applied. It need not be arduous and should be proportional to the risk and complexity of the trial. Monitoring does not need to be conducted by expensive external contractors and there are several straightforward ways to put a simple monitoring system in place.
In-house monitoring schemes
Any member of a clinical trial research team can train as a monitor. Nurses, data managers, pharmacists and trial coordinators all make excellent trial monitors. Trial monitoring can be built into people’s roles so they do not do this full time. This can be a good way to give staff an extra dimension to their role and is an excellent continuous training experience. Research sites can train their trial staff to be monitors and then set up an in-house system where trial teams monitor each others trials. This is a highly credible system and brings the added advantages of facilitating sharing of best practices and encouraging standardisation.
In an in-house monitoring system a monitor would be assigned responsibility for a trial being managed outside their usual working group. So, for example, a research nurse working in a field-based community malaria trial would be assigned a ward-based trial, run by a different PI, to monitor. This scheme produces highly valuable and thorough monitoring whilst giving the monitors an opportunity to learn about the conduct of other trials.
Monitoring reports are written by the monitors and should be reviewed by senior staff. Processes should be put in place so that the research site can respond to any issues identified during the monitoring visit.
During the trial set-up phase, a monitoring plan should be developed by the assigned monitor in conjunction with the trial team. The document details the scope of the monitoring based upon the relative risk and complexity of the trial. The percentage of source documents to be verified should be determined as well as the frequency of monitoring visits. Our ethos is that monitoring should be helpful, supportive and not overly burdensome. We follow the ICH-GCP principle set out in 5.18.3 which says a trial must be adequately monitored and that the nature and extent of monitoring should be determined by the size, complexity and objective.
To download templates and tools for Monitoring, visit our extensive Templates library, or click the links below.
Monitoring checklist – internal
Monitoring activities Template
Monitoring agreement for local independent safety monitor template
Monitoring informed consent checklist
Non compliance to protocol SOP
This article originally appears on the Global Health Trials resources. Please visit us for more resources relating to trials.
Just got started my training as an in-house monitor.