All staff currently working on CTIMPs must complete an ICH-GCP (6) R3 GCP Refresher by 28 April. Training is being updated and courses will begin in February.

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,  please contact the KHP-CTO Training Team for advice.

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.

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.

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.

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)