GCP and the EU Directive for New Staff

Level
Foundation

Aims
The aim is to provide an up-to-date and comprehensive guide to 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) Amendment Regulations 2006, and identify those trials to which these apply
• 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)
• Discuss ethical issues and develop practical skills in obtaining informed consent
• Define Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions, and understand the guidelines for safety reporting
• Have a basic understanding of the audit and inspection process.

Programme
The course will cover the following topics:

• What is meant by Good Clinical Practice and its significance for clinical research
• Key legislative frameworks and regulatory documents
• The role and remit of a range of individuals and organisations in clinical research
• Changes to the ethical review process
• When and how patients should be consented to take part in cancer trials
• The processes and procedures for safety reporting in clinical trials
• Audit and inspection processes and procedures.

Further Information
This course is aimed specifically at those who are relatively new to clinical research and have little or no knowledge of clinical trials. The day will include a combination of presentations and workshops. There will be open forums for discussion throughout the day.

Course Level
Introductory

Accreditation Status
Approved for 10 CPD points from the Institute of Clinical Research (ICR). Please see the ICR website for further details on the ICR accreditation policy and procedures.

Duration
This is a one day course.

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. Networks and host organisations are expected to pay travel, accommodation and other additional expenses incurred by their nominated staff. Failure to take up a pre-booked, confirmed place without giving the necessary notice will incur a £75.00 charge to cover part of the UKCRN Coordinating Centre’s costs. 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