Medical Management Series
Developing the medical management documents and procedures
One of the key responsibilities of the medical monitor during the setup phase is to lead the development of all documents and operational procedures related to the medical management of the study. To uphold safety of the subjects and the integrity of the collected data, all relevant documents should be in place prior to recruiting the first subject in the study. Whenever required, training should also be provided to team members to ensure compliance with the established procedures.
In this phase of the study the medical monitor is most closely involved in developing the Medical Management Plan (MMP), the Safety Management Plan, the Guidance for Management of Major Protocol Deviations, and collaborating with the data management team to develop the Case Report Form (CRF).
The Medical Management Plan
The MMP details the responsibilities of the medical monitoring team and maps the procedural flow for all medical management tasks for the study. The MMP is developed by the medical monitor according to the study-specific requirements and should be finalized prior to enrolment of the first patient. The MMP outlines the roles of all the medical monitoring team members involved in the project whether they are from an external provider such as a CRO, or the medical responsible members at the sponsor. It also defines the various responsibilities of all involved medical monitors including the lead medical monitor and regional medical monitors depending on the scope of the study. The MMP should also include sufficient information on the expected contribution of cross-functional team members towards achieving the goals of the plan.
The key contents of the MMP are:
- The Eligibility Review
This determines the applicable approach for eligibility review, either prospectively or retrospectively in the study, and defines the tools to be utilized.
- The Management of Medical Questions and Guidance Requests
This specifies the communication channels, escalation pathways, and applicable timeframes for managing incoming questions or guidance requests. This also gives the established procedures for building the project-specific knowledgebase and information-sharing with sites and study team. When an interactive guidance management system (IGMS) is deployed for medical management, the relevant information about such a system should also be reflected in the MMP.
- The Medical Review of Study Data
This specifies the various data sets to be used for medical review during study conduct, the frequency of their review and the essential data alerts concerning significant lab abnormalities and/or adverse events of special interest when this is applicable.
- The Management of Protocol Deviations
This outlines the applicable procedures for management and prevention of protocol deviations, especially major protocol deviations that might impact the safety of participating subjects or the scientific integrity of study data, and specifies the applicable methods for identifying, reporting, and recording of protocol deviations.
- Communication and Escalation
The MMP should lay out the established communication methods and escalation pathways with regard to key decision-making concerning medically and scientifically related issues. This is of prime importance in global studies with large medical teams, including various medics from both the sponsor and the involved CRO.
In closing, it should be noted that an efficient method of developing the many associated forms, trackers, listings, and patient profile documents that are to be used during each of the various procedures mentioned in this short article should be considered and produced at the same time as the procedures are developed.
Mohamed El Malt, MD, PhD and Vijayanand Rajendran, MD. (2016) Medical management in clinical trials: A roadmap to operational excellence (Part 2-Study Setup). Journal for Clinical Studies 8(3): 20-23
Mohamed El Malt, Vijayanand Rajendran (2015) Transforming medical management of clinical trials: Search Engine. European Pharmaceutical Contractor, March p40-43.
Mohamed El Malt, MD, PhD and Vijayanand Rajendran, MD (2014) Prevention and Management of Protocol Violations, Feb 11 Issue. Applied Clinical Trials. Available online (Accessed: 11 JAN 2021):
Medical Management in Clinical Trials:
A Roadmap to Operational Excellence
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