Course Description

Focussing on the different phases of drug research, the life cycle of a clinical trial, ICH/GCP and the role of the CRA, this introductory 2-day course is specifically designed for people who have between zero and 12 month's experience as a Clinical Research Associate (CRA).

In addition to the theory, interactive workshops with sample protocols and case report forms (CRFs) will introduce the participants to the fascinating world of clinical research.

All participants receive a free GCP- guidelines booklet !

Learning Objectives

• To provide the basics of the role of clinical research in drug development
• To provide the basic elements of clinical trial methodology
• To detail the principles of Good Clinical Practice (GCP)
• To familiarize the participants with expected job tasks

Programme*

• Introduction to Drug development and Clinical Research
• ICH-Good Clinical Practice
• Essential documents
• Monitoring activities
• Investigational materials
• Adverse event reporting  

• Identification of the right investigator
• Pre-study organisation
• Source data verification and monitoring a clinical trial with sample protocols and CRFs
• Essential Documents
• ICH-GCP quiz
• Study Closure

Certificate of Comprehension

Everyone who participates in our courses receives a certificate of attendance. In addition to this we are now able to offer a Certificate of Comprehension for a growing selection of our courses, including this Clinical Research Training for Junior CRAs course.

Participants receive these certificates after completing an optional one hour test and achieving a test score of at least 70%. The test is composed of multiple choice and case study questions. Participants are allowed to consult their course notes and the extensive training material provided. To choose this option please tick the box when selecting your course date.


Who should attend?

• A must for all inexperienced Clinical Research Associates (CRAs) - no previous knowledge is required
• Clinical Trial Administrators (CTAs)
• Clinical Trial Coordinators
• This course will also be beneficial to people working in related areas such as clinical data processing, biostatistics, regulatory affairs, etc.

*Due to unforeseen circumstances, the programme may change and the ECCRT reserves the right to alter the venue or cancel the event.

Trainer: Marleen Verbeeck, PhD & Gerald Van Roey

Important: In case you have more than 5 interested participants you can save about 50% of your costs by inviting the trainer over for a tailored on-site training