Good Clinical Practice and the Medicines for Human Use (Clinical Trials) Regulations (CTIMP)
About this course
A CTIMP is a Clinical Trial of an Investigational Medicinal Product. This includes any research study that generates new information about the safety or efficacy of a medicinal product.
In the UK, CTIMPs are governed by the Medicines for Human Use (Clinical Trials) Regulations (SI 2004/1031) which has been subsequently amended. Anyone working on CTIMP studies should be trained in both the principles of Good Clinical Practice (GCP) and the Regulations that apply in practice.
This course provides a comprehensive introduction to GCP and the UK Clinical Trials Regulations, equipping you with the knowledge and skills to design, conduct, record, and report CTIMPs to the highest standards.
Course Outline
This course is delivered in an informal but intensive format. Training content includes:
- The principles of GCP.
- Fundamentals of the EU Clinical Trials Regulations.
- Sponsor and Investigator roles and responsibilities.
- The approval and modification process.
- Informed consent requirements.
- Safety reporting obligation.
- Essential documents and trial documentation standards.
Who should attend?
This course is recommended for investigators, research nurses, trial coordinators and others involved in CTIMPs.
This course is appropriate if you are:
- Currently working, or expect to work, on one or more CTIMP(s)
- Involved in both CTIMP and non-CTIMP studies (the general principles taught apply to all types of research)
If you are not expecting to work on any CTIMPs, the GCP for Non-CTIMPs course may be more suitable. If unsure, contact the Training Team for guidance.
Department sessionsÂ
- If a group of staff require training at the same time, a departmental session can be arranged at a time and location that suits you. Sessions can be delivered either face-to-face or remote, depending on availability.
- To request a departmental session, please contact the KHP-CTO Training Team.
Dates & Locations
Accreditation
- 4 CPD points accredited by the Royal College of Physicians.Â
- Meets the minimum criteria for GCP training set by TransCelerate (TransCelerate is a global collaboration of biopharmaceutical companies that sets the industry standard for GCP training. Recognition by TransCelerate means your training certificate is accepted by sponsors, CROs, and regulatory bodies worldwide — reducing the need to repeat training when moving between organisations or studies.)
Cost
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).
