Medical Management Series
Study Set-up and the role of the medical monitor
In this series of short articles, we have so far discussed the role of the medical monitor in the study development phase of clinical trials. We shall now proceed to highlight the responsibilities and activities required of the medical monitor during the study set-up phase, which can be considered to start from the Clinical Trial Application (CTA) to the recruitment of the first patient.
Close collaboration between the medical monitor and other study team members from clinical operations, regulatory affairs, project management, data management and statistics is essential in this phase to build a medical management platform for the duration of the course of the trial.
While setting up the procedures described in this series of short articles, the medical monitor should be mindful of guarding the key objectives of medical management, which are ensuring the subjects’ safety, ensuring compliance with the approved study protocol, and maintaining the scientific integrity of the data during study conduct. The blueprint for medical management and the associated tools to accomplish the project-specific goals and deliverables are conceived in this period.
The more robustly and transparently the medical procedures are defined and documented, the more streamlined it can be later, during the study conduct and close-out phases. Furthermore, the ground rules that structure the safety standards of the study and the integrity of the patient data collected are laid out during study set-up.
The activities that the medical monitor must perform can be grouped into three main categories:
- Providing regulatory support (which we discuss below),
- Leading the development of all documents and procedures related to the medical management of the study, and
- Ensuring the clinical study team are fully trained in all medical-related aspects of the project.
Regulatory support in the study set-up phase
The selected business partners for regulatory services, together with the sponsor’s affiliates in the respective countries, play the primary role in regulatory interactions with the authorities concerned during the study set-up phase, starting with the CTA using the essential documents prepared during the development phase. All relevant study setup activities go in tandem with the proceedings to obtain regulatory approvals.
The medical monitor plays an important role in responding to queries or questions raised by Competent Authorities (CAs) and the corresponding Ethics Committee (EC) or Institutional Review Board (IRB) in the geographical location of the selected study sites. During this period, any required medical or scientific clarification regarding the protocol, study drug or applicable study procedures should be provided by the medical monitor, together with other relevant members of the study team.
Under certain circumstances, the EC or IRB may also require that the medical monitor make himself or herself available to respond immediately to EC/ IRB queries during the actual EC/ IRB meeting where they are discussing the study documents.
Close interaction between the medical monitor, the regulatory affairs colleague and the project manager is essential to ensure that all the relevant regulatory approvals are in place so that the recruitment activities can be triggered as per the study plan.
In the following short articles, we will discuss the key tasks relating to the documents and training required for study set-up.
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
Medical Management in Clinical Trials:
A Roadmap to Operational Excellence
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