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Course Detail

GCP001 - Good Clinical Practice for Lab staff

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.

As this will be a specific to laboratory staff, you will have to complete either a JRMO Face to face introduction to GCP ( GCP001) or similar Transcelatrate accredited course the prior to attending. Please forward the GCP certificate to Rhona.atkin@qmul.ac.uk as soon as possible. You will not be able to attend the JRMO course if you do not submit a Intro to GCP or refreshers certificate .

An online alternative is the NIHR Inro to GCP course: https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/good-clinical-practice.htm

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

Places are limited to 20 people per session so please book early to secure a place via the link below.

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 to. 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.

Objectives

Provided by: Joint Research Management Office

Details

Date: Wednesday 20 May 2020

Venue: Garrod Building 1.21, W, Garrod Building, Whitechapel

Time: 10:00 - 16:00


Tutor

  • Mrs M Good