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Course Detail

GCP002A - Good Clinical Practice GCP Full course Split over two half days

This course is suitable for all researchers who will be conducting trials of investigational medicinal products (including Clinical Trials of Investigational Medicinal Products (CTIMPs)/ drug trials). If you have not previously attended a GCP course and you are currently or likely to be working on one or more CTIMPs sponsored by Queen Mary University of London or Barts Health NHS Trust then you are required to take this GCP 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 Good Clinical Practice for non-CTIMPs course more applicable to your research.

Once you have completed this course, you will be required to attend a GCP Refresher course every two years.

Summary
All CTIMPs conducted in the UK are governed by the Medicines for Human Use (Clinical Trials) Regulations (Statutory Instrument 1031-2004). All staff working on CTIMPs 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 description of the regulations and Good Clinical Practice, and how they should be applied to CTIMPs sponsored by Queen Mary or Barts Health. Topics covered include essential documentation, informed consent, pharmacovigilance, IMP management and local procedures.

Fees
This course is available free of charge for at staff who work for Queen Mary and Barts Health. External attendees should contact cpd@qmul.ac.uk prior to registering to discuss costs.

Objectives

Provided by: Joint Research Management Office

Details

Day 1

Date: Wednesday 16 October 2019

Venue: John Ellis Lecture Theatre, Dental Hospital Basement, Whitechapel

Time: 13:30 - 17:00


Day 2

Date: Thursday 17 October 2019

Venue: John Ellis Lecture Theatre, Dental Hospital Basement, Whitechapel

Time: 13:30 - 17:00


Tutor

  • Mrs M Good