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Regulatory Medical Management in Clinical Trials: A Roadmap to Operational Excellence (Part 2 – Study Setup) In the previous article of this series, we discussed the role of the research physician/medical monitor (MM) during the study development phase, focusing on study design, development of essential documents and selection of business partners. In this edition, the responsibilities/ activities of a clinical research physician, the study MM, during the study setup phase – starting from clinical trial application (CTA) till the recruitment of the first patient – will be detailed. This phase holds significance for the study MM, as the blueprint for medical management and the associated tools to accomplish the project-specific goals and deliverables will be conceived during this period. The more robustly and transparently the medical procedures are defined and documented, the more streamlined it gets later, during the study conduct and close-out phases. Further, the ground rules that structure the safety standards of the study and the integrity of the patient data collected are laid out during this phase.

with the concerned authorities during the study setup phase, starting with the CTA using essential documents prepared during the development phase. All relevant study setup activities go in tandem with the proceedings to obtain regulatory approvals. The MM plays an important role in providing responses to queries or questions raised by competent authorities (CAs) and the corresponding ethics committee or institutional review board (IRB) in the geographical location of the selected study sites. During that period, any required medical/ scientific clarification regarding the protocol, study drug or applicable study procedures should be provided by the MM, together with other relevant members of the study team. Close interaction between the MM, regulatory affairs designee and project manager (PM) is essential, to ensure that all the relevant regulatory approvals are in place to trigger the recruitment activities as per the study plan. Medical Management Documents and Procedures One of the key responsibilities of the MM during the setup phase is to lead the development of all documents and operational procedures related to medical management of the study. All relevant documents should be in place prior to recruiting the first subject in the study, to uphold safety of the study subjects and the integrity of the collected data. Whenever required, training should be provided to involved team members to ensure compliance with the established procedures. Medical Management Plan (MMP) The MMP details the medical monitoring team responsibilities and maps the procedural flow for all medical management tasks for the study. The MMP is developed by the MM depending on the study-specific requirements and it should be finalised before enrolling the first patient in the study. This document outlines the roles of all the medics involved in the project, both the CRO and the sponsor medics. It also defines the various responsibilities of all involved MMs including, when applicable, the lead MM and regional MMs based on the scope of the study. The MMP should also include sufficient information on the expected contribution from different cross-functional team members towards achieving the desired goals of the plan.

In other words, the responsible MM should keep in mind that what is planted in this period will be harvested later on during the study. Regulatory Support The selected business partners for regulatory services, together with the sponsor affiliates in the respective countries, play the primary role in regulatory interactions 24 Journal for Clinical Studies

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