Face-to-face and blended
learning for corporate clients
gcp trainee

UK GCP Refresher

Duration: 1 day

Key Objectives:

To refresh your understanding the principles of ICH GCP and the European GCP requirements for the Clinical Trial Directive (EU Directive 2001/20/EC and EU Directive 2005/28/EC)


Refresh your knowledge of the UK requirements for GCP The and the UK law - The Medicines for Human Use (Clinical Trials) Regulations 2004 and amended regulations



Dr Laura Brown - Course Director, MSc Clinical Research at Cardiff University, UK.


Course Syllabus:


1. Overview & the principles of ICH GCP

• Background to GCP

• Principles of GCP

• EU Directive 2001/20/EC and EU Directive 2005/28/EC


2. Informed Consent

• Informed consent requirements

• Consent in emergency situations

• Inclusion of minors and incapable adults


3. Ethics Committees


• Responsibilities

• Composition, function and Operations


4. Investigator Responsibilities

• Responsibilities of the Investigator

• Compliance with the protocol

• Medical care of subjects


5. Sponsor Responsibilities

• Responsibilities of the sponsor

• Handling and supplying IMP

• Role of the monitor


6. Clinical Trial Documentation

• The Protocol

• The Investigator Brochure

• Essential documents


7. Safety Reporting

• Definitions

• Responsibilities

• What to report, when and how


8. Specific UK Requirements, inc -

• What are the regulatory requirements in the UK?

• The main requirements of the Medicines for Human Use (Clinical Trials) Regulation 2004 (S.I. 2004/1031) (Discussion)

• The UK S.I. 1928

• Emergency consent

• The requirement to report serious breaches in GCP to the MHRA


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