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CTIMP Legislation
There is strict legislation for CTIMPs (clinical trials of investigation medicinal products). Compliance is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). Sponsoring organisations such as UCL, as well as investigators involved in CTIMPs, are inspected by the MHRA on a regular basis.
The Joint Research Office (JRO) is the UCL office responsible for overseeing the UCL-sponsored CTIMPs portfolio. This means UCL sponsorship is only valid if the CTIMP is signed off by an authorised representative of the JRO.
The JRO uses a risk-adapted approach to determining sponsorship and the level of oversight required. Our clinical trials team are here to help chief investigators and their trial teams navigate CTIMPs regulations.
The MHRA has produced a toolkit to help you work out which regulations apply to your trial available from the website of the DH and MRC Clinical Trials Toolkit
IMP (Investigational Medicinal Products)
We can help with sourcing the IMP for your trial and/or verifying that the IMP is effectively and legally sourced. We will also provide technical and scientific advice on IMPs including any placebo, blinding strategy, randomization technical design and dose escalation or reduction. We will also take care of the qualification of the supplier/manufacturer when required.
We need to start this work as early as possible. For help contact contact the IMP Compliance Manager (Sponsor Pharmacist): Mitesh Kunwardia m.kunwardia@ucl.ac.uk
