Course Detail

GCP002 - Good Clinical Practice (GCP) - Full course

This course is suitable for all new researchers conducting trials of a medicinal products (drug trials). If you have not previously attended a GCP course and you are currently or likely to be working on one or more Clinical Trials of Investigational Medicinal Products (CTIMPS/drug trials) then you are required to take the GCP (Full Course).

If you are expecting to be working on both CTIMP and non-CTIMP studies this is also the appropriate course for you, as it covers the general guidance and principles that apply to both types of research. However, if you are not expecting to work on any CTIMPs now or in the future, you may find the Research Governance Framework Course more applicable to your research.

All CTIMPs carried out in the UK are governed by the Medicines for Human Use (Clinical Trials) Regulations (Statutory Instrument 1031-2004). All staff working on CTIMP studies must be trained in the Principles of Good Clinical Practice and the Regulations and their application to research.
This course provides the attendee with an explanation of why Clinical Trials Regulations were introduced, a short description of the regulations and what constitutes Good Clinical Practice.
This course is available for at staff who work for Queen Mary’s University of London and Barts Health NHS Trust, and who will not be charged . Delegates must register before the course and will be issued a certificate upon completion of the course.

Objectives

By the end of this course, participants should be able to:

  • An understanding of the EU Clinical Trial Directive and Good Clinical Practice (GCP), the Human Tissue Act (HTA) and Data Protections Act (DPA).
  • Understand the role of the regulators including Research Ethics Committee (REC), Medicines and Healthcare Product Regulator Agency (MHRA) and Sponsor of the study is (Queen Mary University of London or Barts Health NHS Trust) and the responsibilities of t
  • Attendees will know what approvals and contracts are required before a trial starts
  • Attendees will be able to incorporate GCP at their research site
  • Attendees will understand the requirement for informed consent, identifying eligible participants and safety reporting

Provided by: Joint Research Management Office

Details

Date: Tuesday 2 July 2019

Venue: Clark Kennedy Lec Theatre, W, Queen Mary Innovation Centre, Whitechapel

Time: 09:30 - 17:00


Tutor

  • Mrs M Good