if you are conducting a clinical trial on an investigational medicinal product (CTIMP) then your study has to comply with the Medicine for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.
The KHP Clinical Trials office provides support for these studies.
The KHP Clinical Trials office will lead on co-ordinating these processes.
CTIMPs sponsored by KCL/SLaM
If your study is to be sponsored by KCL and or SLaM then please contact the R&D office at the earliest opportunity.
In addition to the documents required for SLaM R&D approval, those conducting CTMPS will need to provide or have in place the following:
- Evidence of training in Good Clinical Practice is required before R&D Approval will be given.
- Where your trial is sponsored by KCL, SLaM, GSTT, KCH you will also need to provide evidence of Pharmacovigilance, and Trial Master File and Essential Documents training is also required. This can take the form of CVs or certificates for each of these courses. Training is available for SLaM/IoPPN sponsored studies through the Joint Clinical Trials Office. This training needs to have been undertaken, or updated within the last 18 months.
- Confirmation of Clinical Trial Authorisation from the MHRA. We need to have a copy of the final acceptance letter from the MHRA with all remarks having been addressed prior to R&D approval being given for your trial.
This route map details the processes that you need to follow.
There are additional costs associated with clinical trials.
The King’s Clinical Trials Unit (KCTU) offers a range of services to support researchers conducting non-commercial trials including an Independent Randomisation Service; an Online Data Capture and Management Service and a Trial Statistician Service. The KCTU has full Clinical Trials Unit registration by the UK Clinical Research Collaboration (UKCRC), in recognition of its expertise in centrally coordinating multicentre clinical trials, trial design, data management, and analysis.
The Clinical Trials Unit runs a fortnightly clinical trials drop in session. This is for both medicinal and non-medicinal clinical trials.