Learning outcomes

Background

MSBM M105 Laboratory Research Training J.-P. Gillet

MSBM M103 Clinical Trials Y. Geysels

MSBM M104 Statistics applied to preclinical and clinical studies D. Le Tallec

MSBM M108 Quality Assurance: GMP, GCP, GLP and Regulatory Aspects P. Liénard

MSBM M112 Pharmacovigilance J.-M. Dogné

Summary

As a Clinical Research Associate (CRA), it is important during all site visits you are self-confident, knowledgeable and a trustworthy partner for all stakeholders throughout all stages of a trial. A CRA is involved in all stages of a clinical trial, including identifying and setting up an investigational site, monitoring of the trial and then closing it down. The CRA will also act as the main line of communication between Sponsor and Investigator and is the primary contact for the site. In this course, you will gain insight into basic monitoring tasks, how to communicate and present a trial to site staff and act with confidence in your CRA position.

Goals

  • 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 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

Content

  • Presentation of the study team, the clinical trial and the patient from the begin until the end of the study
  • Management of essential documents in a clinical trial
  • Management of the data flow, source data and relevant data
  • Preparation and conduct of qualification/selection, initiation, monitoring visits and audits in an investigational site
  • Various exercises

Table of contents

  • Clinical trial study team
  • Quality of clinical patient data
  • Problem solving and management of issues: deviations, root cause analysis, corrective and preventive actions
  • Essential documents in clinical trials
  • Quality of laboratory data in a clinical trial
  • Clinical trial navigation in a site (logistic)
  • In a patient file: data interpretation, data flow
  • Closing remarks

Exercices

Exercises and/or examples will be provided at each session (3 hours of theory and 2 hours of exercises)

Assessment method

  • The written exam is based on practical cases

The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship, or because of the health situation related to the coronavirus.

Sources, references and any support material

English written notes

Language of instruction

Français