Monitoring in clinical trials

Clinical monitoring is the oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials.

Monitors may be referred to by many different titles. Some of the most common are Clinical Research Associate, Clinical Research Monitor, Study Site Monitor and Quality Specialist.

Almost all field monitoring requires regular visits to the site by the clinical research associate throughout the period of the study. On very rare occasions, an extremely simple, low risk study might be monitored almost exclusively by telephone except for the startup and closeout visits. Since the concept of "low risk" is subjective, this definition should be established in internal policies and procedures.

A clinical research associate (CRA) must determine how to integrate telephone, email, fax and regular mail communications into a monitoring strategy. This will differ among programs and sites depending on available technology, sponsor and site standard operating procedures (SOPs) and personal preference. In monitoring, like any business, many problems can be traced back to a lack of communication, inappropriate communication and/or unclear communication. A good communication strategy should have a high priority in a monitoring plan.

The intensity of monitoring will vary across studies and among sites. Must or should the CRA be present while the site is seeing study subjects? Will the CRA have any interaction with study subjects? In early phase I studies, the CRA may be required to be present during all or part of a subject's treatment. Therefore, the CRA must determine how long they must be there and make appropriate arrangements.

Sometimes a CRA is the sole monitor for a site, while other times the CRA will co-monitor with other CRAs. Establishing who will monitor requires consideration of the sponsor's SOPs, the complexity of the and the condition being studied, the experience of the investigator and staff, and the training and experience of the CRA.

The Clinical Research Associate's overall monitoring plan should remain fairly consistent, but the strategy for individual sites may change considerably during the course of the study depending on study conditions and site performance.

Another key determination in a monitoring plan is the frequency with which the CRA will visit each site. There are a number of factors that must be considered in making this decision:

The protocol dictates the conduct of the study by establishing the procedures that subjects must undergo and a schedule of assessments. The more activities that are required during a study visit, the more monitoring will be required. The disease being studied is also a factor. For instance, if the CRA is monitoring an infectious disease study, the course of the therapy will probably be complete for each subject in about ten days. This requires a different frequency of visits than a cholesterol-lowering study with a treatment period of one or two years.

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