Good Clinical Practice for (non-CTIMP) researchThis 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:
Helpful resources for self guided training on GCP for Non-CTIMPs 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. 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. |
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