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The medical monitor’s role in guiding study conduct
In this short article in the series on optimal medical monitoring for operational excellence, we begin the series of articles that cover the study conduct phase of a clinical trial. We shall discuss the day-to-day medical review and site guidance required from First-Patient-In to Last-Patient-Out.
We have previously described the various activities in the development and set-up phases that prepare the framework for the conduct of the study. The medical management procedures that have been developed will be followed in this phase, and the subsequent close-out phase.
The procedures and pathways defined in the Medical Monitoring Plan, the Protocol Deviations Guidance document, and Safety Management Plan are executed as planned to drive the study progression in the right direction with the aim of meeting study-specific milestones and projections in the process.
One of the primary responsibilities of a medical monitor is to support the study team and sites by providing daily medical guidance under any circumstance and, in the process, to build a knowledge base for the medical and scientific needs of the study, which can be accessed by the whole study team.
Once the investigator and study site has been trained on all aspects of the trial, enrolment of patients may begin. This then marks the beginning of a medical monitor’s role providing site support throughout the conduct phase of the study.
The communication pathway, as delineated in the Medical Monitoring Plan is to be followed by the study team members to request any medical guidance regarding the study protocol. This communication channel forms the main link between the medical monitors and the clinical operations team and is critical in ensuring prompt medical guidance to the sites, thereby ensuring patient safety and integrity of the study data.
In current practice, emails serve as the primary communication channel for this interaction, while phone calls are employed under certain critical circumstances. Usually, medical enquiries are sent from the team members directly to the mailbox of designated medics, or to a common study mailbox where all medical questions are saved, sorted and replied to by the medical monitor responsible. In both cases, a dedicated operational team member is required to sort out the communications, identify the medically significant messages, collate and distribute established answers in the form of a study-specific Question and Answer (Q&A) log and, at the same time, archive them to comply with study documentation needs as per ICH-GCP and 21CFR requirements. Traditionally, Q&A logs serve as a prospective knowledge-building and guidance tool where all pertinent medical communications with the received questions and the provided answers are transcribed, validated by the study-responsible medics, and then distributed to all team members.
The efficiency of medical management with regard to providing daily guidance to investigative sites and other team members is highly dependent on the communication strategy and the channel employed to ensure the timely and efficient delivery and navigation of all medical guidance through the course of the study.
CFR – Code of Federal Regulations Title 21. Available online (Accessed: 01 March 2021):
Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance, Online PDF (Accessed: 01 March 2021):
Mohamed El Malt, MD, PhD and Vijayanand Rajendran, MD. (2016) Medical management in clinical trials: A roadmap to operational excellence (Part 3 -Study Conduct Phase). Journal for Clinical Studies 8(5): 14-20.
Medical Management in Clinical Trials:
A Roadmap to Operational Excellence
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