GCP Refresher for CTIMPs (R3)
Mandatory training requirement
All staff currently working on CTIMPs must complete an ICH-GCP (6) R3 GCP Refresher by 28 April.
This course meets the GCP refresher requirements under ICH-GCP E6 (R3) and the new UK Clinical Trials Regulations which apply to all CTIMPs from this date.
Equivalent ICH-GCP E6 (R3) Refresher GCP courses are also acceptable (e.g. NIHR Good Clinical Practice (GCP) Refresher: GCP E6(R3)) .
If you are unsure if other courses meet these requirements, Â please contact the KHP-CTO Training Team for advice.
About this course
Good Clinical Practice (GCP) requirements for clinical trials are changing.
From April 2026, all Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK must operate in line with ICH-GCP E6 (R3) and the UK Clinical Trials Regulations (2025). These updates clarify expectations in areas such as:
- oversight
- risk-based approaches
- documentation
- transparency.
This course covers what has changed, what remains the same, and how the updated framework is intended to be applied in practice. It is intended to support staff in continuing their trial roles with confidence as the new regulatory framework takes effect.
Course Outline
This refresher course provides a focused update on:
- Key changes introduced by ICH-GCP E6 (R3) and the UK Clinical Trials Regulations (2025).
- Roles and responsibilities of Investigators and Sponsors, including proportionate oversight.
- Risk-based approaches, including Quality by Design (QbD) and Critical-to-Quality factors (CtQFs).
- Submissions, trial modifications, and safety reporting under the revised regulatory framework.
- Informed consent, documentation, and transparency expectations.
- Practical implications for day-to-day trial delivery.
Who should attend?
You should attend this mandatory course if you are:
- Already GCP trained and require a refresher.
- Actively involved in one or more CTIMPs after 28 April 2026.
This includes staff involved in the design, conduct, management or oversight of CTIMPs, or who are delegated trial activities.
Dates and Locations
Wednesday 18 February
In person, Weston Education Centre, King’s College Hospital, 2-4pm.
Tuesday 24 February
In person, Weston Education Centre, King’s College Hospital, 2-4pm.
Wednesday 25 February
Virtual via Teams, 10am-12noon.
Friday 27 February
Virtual via Teams, 2-4pm.
Thursday 5 March
Virtual via Teams, 2-4pm.
Tuesday 10 March
Virtual via Teams, 10am-12noon.
Monday 16 March
Virtual via Teams, 2-4pm.
Thursday 19 March
In person, 16th Floor, Tower Wing, Guys Hospital, 2-4pm.
Thursday 26 March
In person, 16th Floor, Tower Wing, Guys Hospital, 10am-12noon.
Department sessionsÂ
To request a group staff departmental session, please contact the KHP-CTO Training Team.
You will be asked to provide:
- Preferred delivery format (face-to-face or remote).
- Suggested dates and times.
- Confirmation of a room with projection facilities available (if face-to-face).
- Approximate number of attendees.
Cost
This course is free for to staff and students working for a King’s Health Partners organisation:
- King’s College London (King’s).
- Guy’s and St Thomas’ NHS Foundation Trust (GSTFT).
- King’s College Hospital NHS Foundation Trust (KCH).
- South London and Maudsley NHS Foundation Trust (SLaM)
