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Medical Management Series

Set Up Phase

Training the Study Team

The primary responsibility of training all clinical study team members on medically related aspects of the project rests with the study medical monitor. The training of investigator and site staff on protocol specifications and various study-related assessments is a key step before activating a site in the study. This training is usually delivered by the medical monitor in a face-to-face meeting, either individually or in investigators’ meetings on a regional or global scale.

This training serves as the platform to convey all study-specific expectations and responsibilities of the investigators, along with the ICH-GCP principles while undertaking an investigational trial. The training should also focus on the key information within the Investigator Brochure and refer to the significant guidance in sections that will be important during study conduct. The investigators are instructed on the safety profile of the investigational drug with a specific focus given to classes of adverse events that are expected to occur.

In addition to the operational aspects of the protocol, the medical monitor must also provide therapeutic area and disease indication training to all operational team members during the setup of the study. The objective of this is to ensure the team has a clear understanding of the patient population to be recruited in the study and the types of treatment that would be provided. These specific and unique study requirements are therefore to be well-communicated in advance of the study conduct phase.

Detail-oriented and targeted training from the medical monitor drives quality collection, documentation, and monitoring from the sites, and this serves to uphold patient safety and ensure that all data generated are suitable for the planned interpretation and analyses.

To conclude this series of short articles on the study set-up phase, we summarize the responsibilities of the medical monitor. During the set-up phase, the medical monitor must:

  • Take the strategic lead to bring together all required study team expertise for the harmonized conduct of the study,
  • Take key decisions on methodology, tools to be employed, and procedures to be followed for effective medical management,
  • Train the investigators, site staff and study team members on the study protocol, study treatment(s), and relevant procedures.

In the following short articles, we would like to share with you, our colleagues in the field of clinical research, some of the knowledge we have gained from our considerable experience in the field of medical management. We will describe the important roles of the medical monitor during the study conduct phase and break these down to their individual tasks, presenting effective methods to achieve every team’s goal of operational excellence.

Further Reading

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

Europital is a full service CRO operating worldwide and has provided Medical Management for over 10 years. If you would like to receive a free copy of our book, Medical Management in Clinical Trials: A Roadmap to Operational Excellence, or you have a question regarding Medical Management in Clinical Trials please contact us. Your question will be answered by our Chief Medical Officer.

Dr. Mohamed El Malt

Dr. Mohamed El Malt, MD, PhD 
Chief Medical Officer

T: +32 9331 6030
E: [email protected] 
W: https://europital.com