Medical Management Series
The medical monitor’s role in regular data review and safety monitoring
Throughout the lifetime of a study, the medical monitor is required to conduct regular reviews of the data accumulated so far in order to detect safety signals or dubious data capture as early as possible. At the same time, the medical monitor can prompt actions that promote patient safety and data integrity. This step also ensures that considerably clean data are inherited throughout the course of the study.
A systematic review of data should include collective data (both periodic and aggregate) from both the clinical database and safety database, in addition to individual patient review. Usually data listings are used for the collective data review, while patient profiles are used for individual case review.
As the outputs from the databases are usually unstructured data dumps, conducting the regular medical review of data by using those data dumps requires significant amounts of time and effort by the medical monitor. Tailored “smart” listings designed by the medical management team and produced periodically by data management would provide an ideal and operationally efficient approach for regular medical review of data. Smart listings are used for aggregate and periodic data reviews and include data sets retrieved from the CRFs in addition to serious adverse event (SAE) listings retrieved from the safety DB. This collective data review helps to spot any trend or safety signal within the study and/or individual patient data, so that targeted actions such as safety escalation, site or team training, protocol amendments, etc. are performed as needed.
In early-phase safety or pharmacology studies that include a small number of subjects, patient profiles serve the purpose of regular data reviews. This is because the limited data collected in such studies would allow for the review before retrieving collective information via the individual patient profiles. On the other hand, patient profile review is essential in all studies, regardless of the size, for focused individual case review before the designated times of database lock.
It is recommended that review results are summarized in a comprehensive Medical Review Report that is shared with relevant team members. This will serve as a triggering point for all safety and study-related team discussions with informative decision-making and, when applicable, corrective and preventive actions (CAPA) follow-up. To ensure appropriate clarification/correction of review findings, any medical queries that arise from a review should be captured in a designated tracker in which the responses from sites are also indicated. This will allow the medical monitor to review responses to the queries and assess if site response is satisfactory to allow query closure, or whether re-query would be necessary.
CFR – Code of Federal Regulations Title 21. Available online (Accessed: 15 March 2021):
Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance. PDF available online (Accessed: 15 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.
Mohamed El Malt, MD, PhD, and Vijayanand Rajendran, MD. Conveying Medical Guidance in Clinical Trials – A Survey: Communication Challenges, Samedan LTD Pharmaceutical Publishers, White Paper. Available online (Accessed: 15 March 2021).
Transforming Medical Management of Clinical Trials: Search Engine, European Pharmaceutical Contractor, Page 40-43, March 2015
Medical Management in Clinical Trials:
A Roadmap to Operational Excellence
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