Learning outcomes

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, student will gain insight into basic monitoring tasks, how to communicate and present a trial to site staff and act with confidence in a CRA position.

Objectives

• 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
• Etc.

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

Exercises description

Exercises and/or examples will be provided at each session