Please Note:

Course Detail

GCP008A - Good Clinical Practice for non-CTIMP research

UPDATED Aug 2020 - Due to the pandemic we continue to put interim measures in place to deliver the Good Clinical Practice for Non-CTIMPs 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 email me a copy of the certificate ahead of the online tutorial.

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 a mandatory MS Teams tutorial.

You will receive a diary invite for access to the tutorial - please use QMUL or nhs.net email addresses as your email address will be visible. If there are any problems, please contact Rhona Atkin, Clinical Trials Facilitator in JRMO on Rhona.atkin@qmul.ac.uk who is setting up the diary invites.

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This course is a shorter version of the Good Clinical Practice Full Course suitable for researchers conducting health research in an NHS or social care setting which is not regulated by the MHRA – including (but not limited to) observational studies, qualitative studies and interventional studies which do not involve drugs or devices.

Researchers who are or will be working on MHRA regulated trials - Clinical Trials of Investigational Medicinal Products (CTIMPs) or a Clinical Investigations of Medical Devices - must book on to the Good Clinical Practice Full Course instead, as this course will not cover the requirements of these studies.

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

Summary
This course will cover Good Clinical Practice (GCP) and the UK Policy Framework for Health and Social Care Research. The course will explain why the guidelines were introduced, provide a summary of their content and describe how they should be applied to studies sponsored by Queen Mary or Barts Health. Topics covered include essential documentation, local procedures, the informed consent process, as well as the current regulations on Data Protection.

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

Date: Wednesday 14 October 2020

Venue: Online - MSTeams, Microsoft Teams Meeting, Web/Online

Time: 14:00 - 17:00


Tutor

  • Mrs M Good