This content has been updated inline with the latest GCP (ICH-GCP E6 (R3)) and UK Clinical Trials Regulations.

Mandatory training requirement: 

All KHP employed Chief Investigators (CIs) involved in Clinical Trials of Investigational Medicinal Products (CTIMPs) must complete this CI Responsibilities update session by 28 April 2026. 

If you have questions, please contact the KHP-CTO Training Team for advice.

The Chief Investigator (CI) has overall responsibility for the design, conduct, oversight, and reporting of a Clinical Trial of an Investigational Medicinal Product (CTIMP).

With the introduction of ICH-GCP E6 (R3) and the UK Clinical Trials Regulations, expectations for CI oversight, accountability, and decision-making have been clarified, with greater emphasis on proportionate oversight, risk-based approaches, and timely escalation.

This course provides an overview of CI responsibilities under the updated framework, including how these expectations are reflected in KHP-CTO SOPs or, where applicable, other Sponsor SOPs.

The course provides an overview of:

• The transition to ICH-GCP E6 (R3) and the UK Clinical Trials Regulations (2025) effective 28 April 2026.
• Chief Investigator responsibilities and accountability under the updated regulatory framework.

Risk-based and proportionate oversight, including key ICH-GCP E6 (R3) concepts such as Quality by Design (QbD) and Critical-to-Quality factors (CtQFs).

Where to find updated KHP-CTO SOPs, an overview of key changes and when further updates will be available.

This course is normally delivered as a group session.

If you are unable to attend any of the scheduled sessions, or if a small number of CIs  in your  department require training, please contact the KHP-CTO Training Team

One-to-one sessions may be arranged on a case-by-case basis.

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).