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HD InsightsMinding the Counts: Medical Monitor

The Medical Monitor is usually a physician with a good understanding of both the disease being studied as well as the drug being evaluated. The main role is to ensure the safety of the subjects enrolled in the study.

First, the Protocol

The Medical Monitor works in close collaboration with the Project Manager and study team and is typically involved in the development of the protocol as well as the safety monitoring plan. As a Medical Monitor, you ensure that study inclusion and exclusion criteria are appropriately met, you help the sites with questions about adverse events, and communicate severe adverse events to the study team and sites. As you can imagine, you have to know the protocol well!

Drug-Drug Interactions

Another aspect of this role is understanding the potential interactions of the study drug with other concomitant medications. It is important to guide the Site Principal Investigators when a patient starts a new medication during the study.

In my experience as a Medical Monitor, I have personally spent hours researching potential drug-drug interactions. One way to communicate these interactions with sites is to create a summary page, which can be used as a reference each time there is a question about drug interaction. As with most trials, the more you invest in study preparation, the more time you save in the long term. 

Data and Documentation

Another responsibility for a Medical Monitor is creation of a monthly study report detailing trends in study side effects and participant enrollment. This requires a good working relationship with the data management team. My most enjoyable part is the relationships developed with sites. If a site calls me, I typically respond within 24-48 hours, but I provide my cell phone in case there is an urgent need.

One of the most important tips to remember about clinical trials is documentation. It is very important to always follow a phone discussion with a written email rendering the details of the discussion. Remember the maxim: If it is not documented, it didn’t happen. This is important to avoid any misunderstanding, make sure everything is clear, but also to save a copy of the discussion in regular binders that the FDA can audit.

Sometimes, there are automated emails that are sent to sites regarding issues such as lab values and results. It is important to follow up on these emails with the site even if there is no final resolution.

The job of a Medical Monitor is to ensure oversight on every safety feature of the study, and this is audited by regulatory bodies.

A Team Sport Above all, your work as a Medical Monitor is part of the larger study team. The data management team will help you obtain all study information and will send the queries to the site, while the project management team will help you navigate patient-specific issues. Finally, having a back-up is important. There should be a Medical Monitor available at all times. If you plan to be out, make sure to have another Medical Monitor covering for you. Set a time to meet with them before you leave to discuss any pending issues, and after you come back, for a smooth transition.