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Regulatory Medical Management in Clinical Trials: A Roadmap to Operational Excellence (Part 3 – Study Conduct Phase) In this article of the Medical Management series, we discuss the various monitoring activities undertaken by a clinical research physician assuming the role of medical monitor (MM) during the course of study conduct, from first patient in (FPI) till last patient out (LPO). This phase requires inherent medical monitoring activities that involve day-to-day medical review and site guidance. As discussed in the previous two articles, the framework for this study conduct phase is laid down during the development and set-up phase. The procedure and pathways defined in the medical monitoring plan (MMP), protocol deviations (PDs) guidance document and safety management plan (SMP) are executed as planned to drive the study progression in the right direction, meeting study-specific milestones and projections in the process. The number of physicians required to undertake medical monitoring activities is determined by the phase, size and geographic scope of the study. The lead MM holds the reins for all medical management activities that occur in tandem throughout the study conduct. The conventional industry practice for large Phase III studies is to designate a lead MM, along with as many regional MMs as required by the landscape of the study.

arterial link between the MMs and the clinical operations team, and is very 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 prime communication channel for this interaction, while phone calls are employed in certain critical circumstances. Usually the 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 out and replied to by the concerned MM. 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 E6 and 21CFR requirements 1,2. 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.

Guidance Management and Knowledge Building One of the primary responsibilities of an MM is to support the study team and sites by providing daily medical guidance at all required circumstances and, in the process, build a knowledge base for the medical/scientific needs of the study, thereby forming a reference point for the whole study team. The runway to enrolment of the first patient, marked by site and investigator training, kicks off the site support activities to be performed by the MM throughout the study. The communication pathway as defined in the MMP is followed by the study team members to request any medical guidance regarding the study protocol. This communication channel forms the

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. Though e-mails are the commonly-used pathway, their limitations with respect to overload, triage and manual sorting cannot be undermined 3. From a knowledge standpoint, there is an associated risk of significant delay in providing guidance to investigative sites, in addition to the probability of losing out critical medical information during multiple data handling, inherited copy/paste practices and manual sorting. The impact of current practices on guidance quality and the time delay for guidance dissemination,

14 Journal for Clinical Studies

Volume 8 Issue 5

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