SOPs for monitoring Clinical Research trials
Clinical monitoring - Oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials. They want to be certain that safety measures are in place to protect participants.
Functions of the clinical monitor - Clinical Research Associate
How to monitor a study in the field requires considerable thought. 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.
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 your monitoring plan.
The intensity of monitoring
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 protocol 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.
What is the Definition of per protocol population in Clinical trial
The analysis can only be restricted to the participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment. This analysis is known as an "on-treatment" or "per protocol" analysis. Also, the per-protocol restricts the comparison of the treatments to the ideal patients, that is, those who adhered perfectly to the clinical trial instructions as stipulated in the protocol. This population is classically called the per-protocol population and the analysis is called the per-protocol-analysis.