Good Clinical Practice for Clinical Laboratory Staff Evaluating Clinical Trial Samples

This course covers all of the information required for those who will be conducting research in a clinical laboratory or setting-up, overseeing or managing the analysis of clinical samples as part of clinical research.

It is not intended for those who will have significant clinical contact with patients. If you will be working with patients for one or more drug trials - the CTIMP course will be more appropriate. If you will be working with patients but only on non-drug trials (observational, surgical, medical devices etc.) - the Non-CTIMP course will be more appropriate.

Staff and students are only ever required to attend one type of GCP training - if you have attended another GCP course, you are not expected to attend the Laboratory course as well.

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
• Understand the requirements of study setup and oversight
• Be familiar with trial documentation
• 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

  Dates & Venues:

• Monday 13^th January
  Via Teams
  10:00 - 12:30

• Wednesday 26^th February
  Via Teams
  14:00 - 16:30