Clinical Study Management [MSBMM200]

Learning outcomes

Student will learn that managing clinical trials requires an efficient study management of every single aspect of the study in order to be successful;

Student will receive insights about the role of the Clinical Study Manager (CSM) and will learn that CSM leads all aspects of the study and provides continuous feedback on recruitment, site selection, and how to run each phase, throughout the entire duration of the trial;

Student will be aware that the clinical trial management team proactively monitors study milestones to ensure the study is not only successful, but delivered on time and on budget;

Student will understand the need of a Clinical Trial Management System (CTMS) database, a web-based tool that provides sponsors with access to near real-time data and study metrics, empowering clinical trial managers to deliver powerful solutions throughout the drug development process.

Objectives

A study succeeds or fails on the basis of whether it manages to recruit the pre-specified number of participants to reliably answer the question. The objective is to understand and gain thorough knowledge on the management of clinical studies and recruitment strategies.

Content

Next to the fundamental course on ‘Clinical Trials’ (MSBM M103), this course puts more emphasis in the practice of the theoretical concepts. The role of clinical study manager will be explained.

Applicable software system used by biotechnology and pharmaceutical industries will be explained as well, with focus on planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones. 

The course we highlight the following topics:

-Efficient recruitment of trial participants,

-The importance of education and experienced study personnel

-Publication of trial results and dissemination