
Good Clinical Practice and the Medicines for Human Use (Clinical Trials) Regulations - for Pharmacy Staff
About this course
Members of pharmacy staff and students in King’s Health Partners organisations may be working directly on a clinical trial or may come into contact with Investigational Medicinal Products (IMPs) and trial participants as part of their standard duties.Â
This course equips you with the knowledge and understanding required to safely manage IMPs and the documentation related to CTIMPs, in compliance with Good Clinical Practice (GCP) and the UK Clinical Trial Regulations.Â
- This course is recommended if are doing a ‘standard’ pharmacy roleÂ
- You may attend GCP for CTIMP instead if you would a broader understanding of GCPÂ
- If you have already attended the GCP for CTIMP (or other similar) course, you may find this course useful, but it is not mandatory to attend both.Â
- This course also serves as the required refresher. Staff and students should repeat it at the usual interval (every two years for CTIMP research).Â
Who should attend?
- Pharmacy staff and students in any role within KHP organisations.Â
- Pharmacy staff and students who come into contact with IMPs, IMP documentation, and/or clinical trial participants.
If unsure, contact the Training Team for advice.Â
Department sessionsÂ
- 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 provides an informal but intensive introduction to GCP, tailored for pharmacy practice.Â
By the end of the course, you will understand: Â
What GCP is and how it applies to pharmacy
The role of pharmacy in supporting CTIMPs
How the principles of GCP apply to pharmacy practiceÂ
Guidance (e.g., ICH-GCP) and UK Clinical Trial Regulations
How to apply the principles and conditions of GCP to pharmacy practiceÂ
IMP accountability and documentation requirementsÂ
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).