Good Clinical Practice for (non-CTIMP) research

This elective GCP for Non-CTIMPs Course will provide you with an understanding of the ethics and relevant guidance relating to Clinical Research. We focus on research in a clinical setting i.e. In the NHS.

If you are not working on CTIMPs (Clinical Trials of Investigational Medicinal Products) you are not required to be familiar with or adhere to the Medicines for Human Use (Clinical Trials) Regulations, which are the focus of the CTIMP course. Instead we focus on the other regulations, guidance and processes which are applicable to Interventional Clinical Research.

If you are working solely on Non-Interventional Research, this may not be the most appropriate course for you. Please speak to your Sponsor about appropriate training.

Please note.This course does not meet the minimum training requirements for CTIMP studies. Therefore, if you are subsequently required to work on CTIMP studies, you will need to attend the CTIMP GCP Training Course.

If you think that this is the appropriate course for you, please select the booking form below.

If you are unsure or would like further guidance on appropriate training, please feel free to Contact Us.

Course Outline:

This three-hour course will provide staff and students with the necessary skills and knowledge to carry out high quality research and to satisfy the requirements of R&D departments.

By the end of this course you will be able to:

• Understand the guidance that is relevant to your work
• Be aware of the changes to the ethics process and the definition and responsibilities of the Sponsor and Investigator
• Understand the requirements for Informed Consent
• Understand the processes and significance of Pharmacovigilance / Safety Reporting
• Define an Essential Document and understand the requirements for clinical trial documentation and data quality at the trial site
• Understand what a monitor, auditor or inspector will look for when visiting a site

Helpful resources for self guided training on GCP for Non-CTIMPs

UK Policy Framework

Resources for KCL sponsored studies(no NHS trust involvement)

For guidance on which approvals you require (NHS studies)

E-learning modules for studies involving the NHS. Topics include Medical Device studies, research involving exposure to ionising radiation, research involving human tissue & design of research projects.

IRAS help

Updates:

KHPCTO policies do not require staff and students working solely on non-CTIMP studies to have GCP updates. Therefore, we do not provide a non-CTIMP Refresher.

If another organisation (such as a sponsor or R&D department) does require you to have an update - and doesn't provide one - then you can attend another non-CTIMP course or attend our standard Refresher course, on the understanding that it is primarily focussed on CTIMP research.

Costs:

This course is available for KCL, IoPPN, KCH, Guy’s, St Thomas’ and SLaM staff and students. This training is supported by the King's Health Partners Clinical Trials Office; therefore there is no charge to delegates.

  Dates & Venues:

• Monday 13^th May
  Via Teams
  13:30 - 16:30

• Tuesday 11^th June
  Tower Wing, Guy's Hospital
  09:30 - 12:30

• Wednesday 26^th June
  Via Teams
  13:30 - 16:30