The Gold Standard Course for Clinical Research Associates (CRAs)
The International Conference on Harmonisation Topic E6 (R2) “Guideline for Good Clinical Practice” (ICH GCP) sets out the responsibilities of those involved in conducting clinical research. Section 5.18.lists the responsibilities of the Sponsors’
monitors or Clinical Research Associates (CRAs). The requirements to comply with the conditions and principles of ICH GCP are documented in The European Directive 2005/28/EC and also the clinical Trail Regulation 536/2014/EC which is expected to be fully implemented in 2017.
This training course has been developed based on the Cogent Gold Standard for the CRA role profile which has been reviewed by Industry and lead bodies.
The CRA must have the underpinning scientific knowledge to be able to relay the protocol and therapeutic area requirements to the site staff conducting the study. The course addresses all relevant aspects of ICH GCP and the EU Directives and Regulation but is practical in nature to give a real insight into the CRA role.
The course is relevant for anyone new to clinical research introducing them to the various aspects of clinical research and the role of the CRA. It will be of interest to all disciplines involved within the clinical study team but ideally delegates will be current and potential CRAs in pharmaceutical, biotechnology CRO and SMO –companies, or within non-commercial organisations.
About this course
The course (formally known as the “Intro course”) formed part of the maters in clinical research at Liverpool and then Cranfield University and has been subject to rigorous programme review. The course starts by ensuring that the delegate is able to relate the relevance of clinical trials to the drug development process. It covers the roles and responsibilities of those conducting research paying particular attention to the role and responsibilities of the CRA. There is a review of the legislative requirements applicable to the role of the CRA. Trough practical workshops and case studies delegates will develop the skills to take an active part in the execution of research monitoring, describing the requirements for conducting monitoring visits based on risk assessment criteria.
About your Trainer
Sue Fitzpatrick has more than 30 years’ Pharmaceutical Industry experience.
She has been responsible for the management and audit of CRAs, CROs and clinical trials in a wide range of therapeutic areas. As former Director and Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and for postgraduate courses in collaboration with several UK Universities. Sue holds accredited teacher status at Cranfield University and continues her collaborations but as a consultant trainer conducting courses in many topics including risk based monitoring (RBM). Sue is currently a Director of Redtree People and continues her work on enhancing competencies and standards, writing industry gold standards for CRAs in collaboration with COGENT the sector skills council.
She was a member of the GCP committee of the Faculty of Pharmaceutical Medicine and helped develop a certification examination for physicians and other research personnel. She has authored many articles and books on clinical research, risk based/centralised monitoring and career development topics. Sue recently published a book in Clinical and Healthcare Research for the Oxford University Press.
What people have said about the course
“Wonderful training thank you!”
“Very interesting and enthusiastic”
“Good presentation style and engaging presenter”.
The course has been designed to give a balance between trainer input, exercises, and delegate interaction.
Performance and Learning Outcomes
On successful completion of this module the delegate should be able to:
Relate the relevance of clinical trials to the drug development process
Summarise the ethical and regulatory requirements that must be met before a clinical trial commencement
Design a simple protocol and draft appropriate data capture tools
Demonstrate the basic principles of patient protection and data validation
Describe the requirements for conducting monitoring visits based on a risk approach
Identify safety aspects of a trial and their reporting requirements
Understand how to review the effectiveness of an organisations quality system and implement effective CAPA to address any shortfall
An introduction to:
Drug development – from test tube to man
Statistics for CRAs
Clinical trial design
Patient safety – ethics committees and informed consent
Patient safety – adverse events and adverse drug reactions
Attributes of a monitor
Investigator selection and motivation
Source data verification
Clinical trial monitoring based on a risk approach
The monitoring plan