This elective course introduces principles of Good Clinical Practice (GCP) and the ethical guidance and frameworks relevant to non‑CTIMP interventional research, typically conducted in NHS settings.

A non‑CTIMP study is an interventional clinical research study that does not involve an Investigational Medicinal Product (IMP). Examples include:

• Surgical or procedural interventions
• Medical device studies
• Behavioural or therapy interventions

Non‑CTIMPs fall outside the Medicines for Human Use (Clinical Trials) Regulations for medicinal products. This course therefore focuses on the guidance, frameworks and processes that apply.

Please note:

• This course does not meet the minimum training requirements for CTIMP studies.
• If you later work on CTIMPs, you must complete the CTIMP GCP Training Course.
• If you are working solely on non‑interventional research, this course may not be appropriate. Please speak to your Sponsor about suitable training.

Good Clinical Practice (GCP) provides the ethical and scientific standards for designing and conducting research involving human participants.

This course explains how GCP applies to non‑CTIMP research conducted in NHS settings and what this means for researchers working on these studies.

This course covers:

• Purpose and importance of Good Clinical Practice (GCP)
• UK Policy Framework for Health and Social Care Research and other relevant guidance, such as ICH‑GCP E6(R3), the international standard for GCP
• Roles and responsibilities of Investigators, Sponsors and research staff
• Oversight of research studies, including proportionate approaches to study management
• Study approval processes, amendments and transparency requirements
• Core research processes such as informed consent, safety reporting, documentation and data quality

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).