In this course, student will acquire a deeper understanding of the basic monitoring tasks, of how to communicate and present a trial to site staff and how to act with confidence in a CRA position. By the end of the course, students are expected to develop the following abilities:
· Ability to communicate with the pharmaceutical industry through evaluation, initiation, monitoring visits, and audits;
· Management of trial logistics in an investigational site or in a pharmaceutical company;
· Ability to explain the tools/documents that are used to select, follow and evaluate a patient in a given protocol;
· Ability to monitor quality and safety issues at site and discover acceptable solution for the sponsor and the investigational site.
· Apply risk-based and critical-to-quality judgement to identify, assess and prioritise monitoring findings according to their potential impact on participant protection, data reliability and regulatory compliance;
· Analyse quality and safety issues, identify their underlying causes, and propose proportionate corrective and preventive actions, including appropriate follow-up and escalation;
· Communicate and document monitoring findings, decisions and required actions clearly and effectively across investigator-site, sponsor and CRO interfaces, including during critical conversations.
Since there are three different lecturers (Lien Verheggen, Elena Carceller Zazo and Pr. Charlotte Beaudart), the course will be organized into three distinct sections:
1. Lien Verheggen will provide a module designed to develop the professional judgement underpinning CRA work: how to protect trial participants, safeguard reliable trial results, recognise and prioritise meaningful issues, and support effective corrective action across sponsor, CRO and investigator-site interfaces. The module will address the roles and accountabilities within the clinical-trial team; the practical use of key trial documents, including the protocol, investigational product manual, Investigator’s Brochure, informed consent documentation and delegation log; and protocol-specific requirements relating to inclusion and exclusion criteria and participant safety. It will also cover risk-based and critical-to-quality thinking, issue assessment, root-cause analysis, corrective and preventive action (CAPA), proportionate escalation, documentation, and critical conversations. Through cases, discussion and practical exercises, the emphasis will shift from information transfer and memorisation towards decision-making and application. The module will also reflect the evolving regulatory and technological environment in which CRAs work, including the appropriate use of advancing technologies and information platforms.
2. Elena Carceller Zazo will provide a module on the monitoring visit lifecycle, following a site from selection to closure. It will cover site selection and qualification; site initiation; interim monitoring, including consent review, source data verification, query management; and close-out. Cross-cutting themes include IMP accountability and reconciliation, data integrity and ALCOA++ in line with ICH E6(R3), and visit documentation from confirmation letter to monitoring report. Through mock visit documents and role-play, students will practice preparing and conducting each visit type and applying a risk-based monitoring strategy.
3. Pr. Charlotte Beaudart's sessions will be divided into two parts:
First, Prof. Jonathan Douxfils will give a module about the management of laboratory data for clinical trials. This session will offer students valuable insights into the practical aspects of laboratory data management within the clinical trial landscape.
Second, Pr. Beaudart will encourage students to engage in group discussions to collectively summarize the key responsibilities of CRAs within the context of clinical trial development and management.The module or Pr. Beaudart will also cover discussion/work on patient informed consent sheet.
See content section
Exercises and/or examples will be provided at each session
A course book will be provided to students at the beginning of the course; it will include an introduction, the course structure, the educational format, the schedule, the course objectives, the examination modalities, the language of instruction, and the professor’s contact information.
PowerPoint presentation will be used during classes - will be made available on Webcampus.
Discussions and exercises on clinical cases and real situations coming from hospital and pharmaceutical companies will be proposed.
Written exam
English written notes
| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Biomedical Sciences | Filière en gestion de la recherche clinique | 2 | 2 | No |