Good Clinical Practice (GCP) for Clinical Laboratory Staff Evaluating Clinical Trial Samples

The MHRA assess labs that perform work in support of clinical trials in accordance with the EMA's Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples. This course summarises the key elements of this guidance through presentation and workshop discussion.

This course is intended for those whose only or primary engagement with research will be the analysis of samples - in place of standard GCP training. If you have already attended the standard GCP course then this may be of use or interest to you if you are analysing samples but it is NOT mandatory to attend this course in addition.

Lab Booking Form

If you are unsure or want further guidance on appropriate training, please feel free to contact us.

Course Outline

During this two and a half hour course, delegates will be asked to consider the key principles of GCP and how quality systems can be developed and maintained to ensure that the rights, safety and wellbeing of clinical trial subjects are protected and that data is reliably and accurately reported.

By the end of this course you will:

  • Know what GCP is and how it applies to you
  • Understand the regulations which apply to clinical trials
  • Be aware of key requirements of GCP including subject safety, confidentiality and consent
  • Be aware of important aspects of study conduct
  • Understand what an MHRA inspector will look for when visiting a lab

CPD Creditation:

The Royal College of Pathologists does not approve local or regional meetings for CPD-purposes. RCPath CPD scheme participants who attend can self-accredit at a rate of one credit per whole hour of learning.

Costs:

This course is available for KCL, IoPPN, KCH, Guy’s, St Thomas’ and SLaM staff. This training is supported by the King's Health Partners Clinical Trials Office (KHP CTO); therefore there is no charge to delegates.

 

  Dates & Venues:

  • Friday 27th April 2018
    CRF Meeting Room,
    15th Floor, Tower Wing,
    Guy's Hospital
    09:30-12:00

  • Tuesday 29th May 2018
    Boardroom,
    Weston Education Centre
    Denmark Hill
    09:30-12:00

  • Thursday 28th June 2018
    Meeting Room 1,
    16th Floor, Tower Wing,
    Guy's Hospital
    13:00-15:30