Clinical Trial Monitoring

CLINICAL TRIAL MONITORING- A GRADUAL PROCESS

BY

OGUNDOKUN OLUSEGUN.

PGD (Clin. Res. (Can.)), BMLS (Nig,) MGHT, M-ASLM, MACRP.

So you’re new to monitoring clinical research trials? Well, welcome. You’re probably starting out with little formal training, some knowledge of relevant FDA regulations, and a sense that the rules are just the tip of the iceberg. In addition, it’s likely that you aren’t certain what questions you should even ask about clinical trial monitoring. You are, however, not alone. Most monitors start their jobs in a similar state of confusion. Unfortunately, the job is difficult to delineate, since it is more art than science, more luck than skill, and more experience-driven than textbook-learned. Nevertheless, there are questions that can help you get started in the right direction. For example, what do monitors do and how do they go about doing it? What are the best ways to manage research sites, coordinators, and investigators? And most importantly, what is a monitor’s day-to-day job really like? What is the job;  How is it done?

Put simply, the monitor’s responsibility is to “monitor the conduct of a research trial.” Thank you very much. But if you’re looking to the Code of Federal Regulations (CFR) for guidance, that’s about all you’re going to get. For example, there is no guide to assist monitors in selecting research sites (although they’re usually the ones to do it), there is no regulation that outlines the tasks appropriate for a site visit (but there is a necessary set), and there are no rules to dictate the frequency of such visits. Clearly, to monitor trials effectively, more than an understanding of job definition is necessary.

It goes without saying that monitors must know both the CFR and their assigned research protocols. After all, a large part of the monitor’s job is to advise and assist sites in conforming to FDA regulations while also helping them meet the requirements of particular research studies. Thus, a monitor should...