This is an elective GCP course for staff involved in Medical Device Clinical Investigations.

If you are working on a Medical Device Clinical Investigation, this course provides the Good Clinical Practice (GCP) training appropriate to your role.

Please note:

• If you are working on a Clinical Trial of an Investigational Medicinal Product (CTIMP), you must complete the Introduction to GCP for CTIMPs (R3) course.
• If you are working on non-CTIMP interventional research that does not involve a medical device, you should complete the GCP for Non-CTIMPs (R3) course.
• If you are unsure which course is appropriate, please contact the KHP-CTO Training Team.

This course provides an introduction to Good Clinical Practice (GCP) for Medical Device Clinical Investigations. It is based on the principles of ISO 14155:2026, the international GCP standard for medical device clinical investigations, together with the UK Medical Devices Regulations 2002, relevant MHRA guidance, and the principles of ICH GCP E6(R3).

The course:

• Provides an overview of the key principles and regulatory requirements for Medical Device Clinical Investigations.
• Explains the roles and responsibilities of those involved in conducting clinical investigations.
• Is not intended to provide detailed study-specific or organisation-specific guidance.
• For advice on individual studies or local processes, please contact your Sponsor or local R&D/RDO office.

The course covers:

• Good Clinical Practice principles for Medical Device Clinical Investigations
• The UK regulatory framework
• Medical device classifications and intended purpose
• Roles and responsibilities
• Study approvals and conduct
• Informed consent
• Safety reporting and Device Deficiencies
• Documentation, quality management, monitoring and oversight

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).