FAQ on Medical Monitoring Services

Navitas Life Sciences is a leader in accelerating the movement of therapeutic agents from the lab to the market, with safety and efficiency in focus. Our Medical Monitors have vast therapeutic knowledge and clinical research experience to provide strategic and specific support throughout the clinical trial.

Read on to find answers to frequently asked questions about medical monitoring from our experts.

Who is a Medical Monitor in a Clinical Trial?

As per ICH-E6 guidelines, the sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial-related medical questions or problems. The contact details of this medical personnel are written on trial protocol. This medical personnel is usually addressed as Medical Monitor.

What are the responsibilities of a Medical Monitor?

Medical monitor is the clinical team’s proponent for subject safety and wellbeing. This is limited not only to individual subject safety, but also includes medical assessment of the clinical study protocol for feasibility, risk assessment, input into study design, study duration and comparator selection.

During the study the medical monitor is the scientific backbone of the clinical team. Responsibilities include interaction with site investigators to provide them with study drug information, unblinding decision, subject eligibility approval, protocol deviations review, ongoing assessment of the medical and safety aspects, providing medical and therapeutic area expertise to project team, results review and interpretation, and helping to ensure overall project success. Some examples of medical monitor responsibilities:

• Examining the protocols of a clinical study
• Planning and initiating a trial.
• Answering eligibility related questions from investigative sites, and study teams.
• Answering questions specific to the protocol during the site start-up process
• Addressing safety issues across the study from sites and the study team
• Providing guidance for when a subject needs to be unblinded due to medical emergency.
• Reviewing line listings for coded events to verify MedDRA consistency
• Dealing with data (analysis, Interpretation, exploration)

In a nut shell, the medical monitor plays a unique bridging role between the site, rest of the clinical development team, pharmacovigilance and regulatory department.

What is the educational qualification(s) and expertise of a Medical Monitor?

The regulatory or ICH-GCP guidelines does not categorically specify the educational qualification and expertise of the medical monitor. But usually, a medical monitor is required to have a medical degree equivalent to MBBS or MD. In addition, medical monitors should have specialized training related to clinical research and the pharmaceutical industry.

Since medical monitors provides guidance on medical and scientific questions from investigators, regulatory personnel, and other clinical study team members, they should have sharp medical and study-specific knowledge. Sometimes residency in the work-specific department is helpful.

Some examples of skills required to be a medical monitor:

• Medical degree with strong leadership skills
• Knowledge of both regulatory requirements as well as the ICH-GCP
• Skillful in converting input into regulatory documentation.
• Strong communication skills to deal with stakeholders either internal or external.
• Strong writing and presentation skills.
• Skillful to deal with medical and scientific community.
• Work experience in medical monitoring or drug safety experience in a CRO or pharmaceutical organization.
• Appropriate knowledge of research, clinical trials and clinical terminologies.

What is the difference between the role of a CRA and a medical monitor?

A CRA’s primary role is to ensure that clinical trial sites are complying to trial protocols and reporting requirements, whereas, a medical monitor provides medical expertise for trial oversight and safety concerns.

What is the difference between the role of an investigator and a medical monitor?

The term medical monitor often gets mixed with term principal investigator, but both are very different. Medical monitors provide physician-level expertise for the sponsor on multiple trials/sites whereas an investigator is responsible for only it’s site-specific trials.

The medical monitor should not interfere with the investigator’s responsibility for medical assessment and treatment of individual subjects, but should provide the investigator with all medical information known by the company to ensure that the best treatment decisions may be made.

What is Medical Monitoring Plan (MMP) in clinical trials?

The responsibilities of medical monitoring team and procedural flow for all medical management activities are documented in a MMP.

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