GCP and the EU Directive for Clinical Trials (Online)

Level
Foundation

Aim
To provide an up-to-date and comprehensive overview of the principles of ICH Good Clinical Practice (GCP), and the EU Directive for clinical trials.

Learning Outcomes
Following the course, participants will be able to:

• Understand the historical development of Good Clinical Practice (GCP) and its impact upon clinical research
• Recognise the key elements of ICH GCP and the Medicines for Human Use (Clinical Trials) Regulations 2004, and identify those trials to which these apply
• Understand the process from development to closure of a trial – including the timelines, elements, development and approval processes of trial documentation
• Define roles and responsibilities of different individuals and organisations in clinical research
• Review the ethical approval process and understand the new Governance Arrangements for Research Ethics Committees (GAfREC)
• Understand the process of gaining informed consent
• Define Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions, and understand the guidelines for safety reporting
• Recognise the impact of GCP and GMP on the manufacture, import and labelling of IMPs and inspection processes to verify compliance.

Programme
The course is structured in the following way:

• Each of the two modules is a stand-alone module which needs to be completed in the recommended order
• The learning material is underpinned by using scenarios from the workplace and delegates are encouraged to consider how the principles could be applied to their own work situation
• Quizzes and challenges are utilised as a knowledge check and can be used to identify knowledge gaps.

Cancellation Policy
UKCRN courses are offered free of charge to all staff and public and patient representatives working on or associated with the UKCRN portfolio of studies. Failure to complete this course within three months of registration date will incur a £75.00 charge to cover UKCRN’s costs, including cancellation of enrolment on the course following the UKCRN’s purchase of a delegate licence. By accepting enrolment on this course, the UKCRN will determine that you are fully aware of the booking and cancellation/non-completion policies, and agree to the terms and conditions contained within these documents.

Accreditation Status
Approved for 5 CPD points from the Institute of Clinical Research (ICR). Please see the ICR website for further details on the ICR accreditation policy and procedures.