Please Note:

Course Detail

GCP001 - Good Clinical Practice for Lab staff

UPDATED Aug 2020 - Due to the pandemic we continue to put interim measures in place to deliver the Good Clinical Practice courses. This means there will be pre-course requisites and shorter concise online sessions.

Please ensure you have completed either a JRMO led Full GCP course or JRMO GCP refresher. Please register JRMO course via the QMUL CPD Booking system and email me a copy of the certificate.

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 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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Scope

This course is suitable for all laboratory staff and researchers who will be handling laboratory samples from any MHRA regulated study. It is suitable for all levels of research knowledge.

The material in this course is bespoke and not a repetition of any other JRMO GCP course.

Summary

It is acknowledged that the nature of laboratory work performed in support of clinical trials is very diverse and consequently the way laboratory work is organised will be variable. However, there are regulations and standards that must be adhered too. This course covers the EMA reflection paper for laboratories that perform analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010) and MHRA guidance on clinical trial samples and GCP.
It will outline applicable standards and expectations of a laboratory, which will be handling clinical trial samples. This will include topics such as quality systems, organisation of laboratory work, transportation of samples, method validation, processing, facilities and equipment, and the laboratory’s relationship with the trial participants.

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.

We will send a diary invite upon registration (email addresses will be visible - please use NHS or QMUL email addresses only).

Objectives

Provided by: Joint Research Management Office

Details

Day 1

Date: Wednesday 21 October 2020

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

Time: 13:30 - 16:00


Day 2

Date: Thursday 22 October 2020

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

Time: 13:30 - 16:00


Tutor

  • Mrs M Good