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CROPHA CRO

 

CRA TRAINING (CLINICAL RESEARCH ASSOCIATE)

6-DAY PROGRAM - GROUP
This is a program for new CRAs and is designed to provide all the knowledge needed to effectively begin work as a Clinical Research Associate in the pharmaceutical sector.
 
The course focuses on both the theoretical and practical issues of monitoring clinical trials and will prepare participants to be fully operational on completion. Course content covers important aspects of the regulations in force concerning human experimentation, as well as good clinical practices and a CRA's responsibilities during each visit to the investigator's research site.
 
TARGET GROUP: Nurses, graduates in life sciences (biology, chemistry, pharmacy etc.) doctors, physiotherapists etc.
 
DAY 1:
INTRODUCTION TO CLINICAL RESEARCH
REGULATION
INFORMED CONSENT
 
A full introduction to the pharmaceutical sector and field of clinical research, together with an extensive description of the role of a CRA and the qualities required to meet this professional challenge will be covered. This introductory module includes the regulatory aspects of a clinical study due to the implementation in 2004 of the European Directive on Human Experimentation in Belgium, which has brought about many changes in terms of procedures and timescales. Full information on the rules currently enforced by the Ethics Committees and Competent Authorities will be addressed.
 
These include rules regarding the initiation of a clinical study, changes or amendments made during a study, reporting of a SUSAR (Suspected Unexpected Serious Adverse Reaction) and the closure of a clinical study. The module will also include information needed by a CRA to verify the content of an informed consent and the correct procedure for obtaining a written consent from any subject taking part in a clinical study – with the different and various steps to be followed for under-age subjects and of-age subjects.
 
DAYS 2 – 6:
SITE IDENTIFICATION (1 DAY) & SITE SELECTION VISIT (1 DAY)
SITE INITIATION VISIT (2 DAYS)
SITE MONITORING VISIT (1 DAY)
SITE CLOSURE VISIT & ERRORS, MISCONDUCT & FRAUD (1DAY)
 
A CRA is responsible for ensuring that any clinical study is conducted in accordance with the protocol and Good Clinical Practice, and complies with legislation. This module will provide information regarding the establishment, regular monitoring and closure of a clinical study at the selected investigative site. Each type of site visit is reviewed stage by stage, including preparation for the visit, visit activities, administrative and logistical follow-up of the visit. The course includes practical exercises aimed at putting trainees in situations similar to those they would encounter in their professional CRA role.
 

 
Cropha CRA Services
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