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Course Detail

GCP001 - Good Clinical Practice for Lab staff

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 knowledge with or without previous GCP training.

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 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 November 2019

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

Time: 12:30 - 17:00


Tutor

  • Mrs M Good