
Good Clinical Practice and the Medicines for Human Use (Clinical Trials) Regulations - for Laboratory Staff
About this course
This course is designed for staff and students involved in laboratory work or procedures within clinical trials. This may include setting up, overseeing, or managing the analysis of clinical samples, either as part of your standard laboratory role or through specific delegated tasks to support a trial.Â
This course equips you with the knowledge and understanding to manage laboratory processes and documentation for CTIMPs, in compliance with Good Clinical Practice (GCP) and the UK Clinical Trial Regulations.Â
This course is:
- Recommended if your primary role in research involves laboratory work or clinical sample analysis.Â
- Not intended for those with significant clinical contact with participants:
- If working with patients in drug trials, it is recommended you take the GCP for CTIMPs course.
- If working with patients in non-drug trials (e.g. observational, surgical, or device studies), it is recommended you take the GCP for Non-CTIMPs course.Â
You are only required to complete one type of GCP training — if you have attended another GCP course, you are not expected to take this one as well. However, you may attend both sessions if you find it usefulÂ
This course also serves as the refresher training for laboratory staff. Repeat at the usual interval (every two years for CTIMP-related work)Â
Who should attend?
- Laboratory staff and students working with clinical trial samples.Â
- Staff responsible for setting up, overseeing, or managing the analysis of clinical samples for research.Â
If unsure, contact the Training Team for advice.Â
Department sessions
- If a group of staff in your department require training at the same time, a departmental session can be arranged at a time and location that suits you. Sessions can be delivered either face-to-face or remote, depending on availability.Â
- To request a departmental session, please contact the KHP-CTO Training Team.Â
Course outline
This course explores the key principles of GCP and how quality systems in the laboratory can protect participant rights, safety, and wellbeing while ensuring reliable and accurate data.Â
By the end of this course, you will understand:Â
What GCP is and how it applies to laboratory staff and students
Regulations & guidance that apply to clinical trials, (e.g. ICH-GCP)
Requirements for study setup in the laboratory
Investigator and Sponsor oversight
Quality systems and requirements in the lab for clinical trials
The importance of accurate record keeping and documentation standards
Cost
This course is available free of charge to staff and students working for a KHP organisation: King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology & Neuroscience (IoPPN).