Due to the cessation of face-to-face teaching on QMUL campuses, some changes have been made to the current provision. Check the Venue column for information. Sessions will either proceed online at their scheduled times or will be POSTPONED with further notice. Please check your email as you will likely have received notice, or contact your tutor for more information | Introduction of new booking system

Course Detail

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

UPDATE May 2020 - Due to the pandemic we have been forced to put interim measures in place to deliver the Good Clinical Practice Full course in a new blended and MS Teams based format. To that end, we would require you to complete the NIHR 'Introduction to GCP eLearning' (please use link https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm) prior to the session.

Please could you email me a copy of the certificate ahead of the online course.

There will no extra pre-reading.

The NIHR course will establish a firm foundation focusing on delivery of research at a site level but the JRMO course additionally needs to include the information needed for CI responsibilities, BH and QM sponsorship requirements and JRMO SOPs which is why, in addition to the NIHR eLearning, we have also arranged two mandatory MS Teams based sessions of 1hr - 1.5hr on June 16th and June 17 starting at 14.00 with pre-reading required between the sessions (I will email a link to the resources).

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: Tuesday 16 June 2020

Venue: Online, Online, Online

Time: 14:00 - 15:30


Day 2

Date: Wednesday 17 June 2020

Venue: Online, Online, Online

Time: 14:00 - 15:30


Tutor

  • Mrs M Good