
GCP Refresher
About this course
All staff and students involved in Clinical Trials of Investigational Medicinal Products (CTIMPs) must refresh and update their knowledge of Good Clinical Practice (GCP) and the UK Clinical Trial Regulations every 2 years.Â
This course is designed to refresh your understanding of the core principles, regulations, and processes that apply to CTIMP research. It is a prerequisite that you have previously attended the GCP for CTIMPs course (or an equivalent) within the past 2 years. Â
This course:
- Is required for all staff and students working on CTIMPs to remain compliant with the 2-year refresher requirement.Â
- Presumes an existing level of knowledge. If you have not recently been involved in research, the Introductory GCP for CTIMP course is recommended instead.Â
KHP-CTO does not require GCP refresher training for non-CTIMP studies. You may choose to attend a Refresher session, but please note the content is CTIMP-focused.
Who should attend?
- Staff and students across KHP organisations working on CTIMPs who have already completed GCP training.Â
- Those required to maintain compliance with the 2-year refresher requirement for CTIMP research.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 interactive session will refresh your knowledge of:Â
UK Clinical Trial Regulations and guidance (ICH-GCP)
Roles and responsibilities
Clinical trial approval process
Informed consent process
Pharmacovigilance (safety reporting)
Essential documents and record keeping
AccreditationÂ
- 2 CPD points accredited by the Royal College of Physicians.Â
- Meets the minimum criteria for GCP training set by TransCelerate.Â
TransCelerate is a global collaboration of biopharmaceutical companies that sets the industry standard for GCP training. Recognition by TransCelerate means your certificate is accepted by sponsors, CROs, and regulators worldwide — reducing the need to repeat training at different organisations.Â
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).
