This elective course provides an introduction to the principles of Good Clinical Practice (GCP) and the ethical guidance and frameworks relevant to non-CTIMP interventional research, typically carried out in an NHS setting. 

A Non-CTIMP study is any 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 remit of the Medicines for Human Use (Clinical Trials) Regulations. This course 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. 

Refreshers

• The KHP-CTO does not require GCP refresher training for non-CTIMP studies. If another organisation (e.g. Sponsor or R&D department) requires an update and does not provide one: 
• You may re-attend a Non-CTIMP course, or 
• Attend the standard Refresher course (noting that its focus is primarily CTIMPs).