Staff new to working on Clinical Trials of Investigational Medicinal Products (CTIMPs) should complete an Introduction to Good Clinical Practice (GCP) training session.

Training should reflect the principles of ICH‑GCP E6(R3), which is the latest international guideline for Good Clinical Practice. This course meets the GCP requirements of ICH‑GCP E6(R3) and the UK regulations governing CTIMPs.

TransCelerate‑accredited GCP training provided by other organisations is also acceptable.

If you are unsure whether another course meets these requirements, please contact the KHP‑CTO Training Team for advice.

Good Clinical Practice (GCP) sets the standards for how clinical trials involving medicines should be conducted.

This course explains how CTIMPs are conducted and what this means for research staff in order to protect research participants and ensure reliable results.

• Purpose and principles of GCP

• UK regulations and guidance for CTIMPs

• Roles and responsibilities of Investigators, Sponsors and staff

• Quality by Design (QbD), Critical-to-Quality Factors (CtQFs) and proportionate risk

• Overview of trial design: phases, randomisation and blinding

• Study submission, modifications and transparency (registration and results reporting)

• Core trial processes: consent, IMP management, safety reporting and essential documentation

To request a group staff departmental session, please email: khp-ctotrainingteam@kcl.ac.uk

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).