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Use this form if you’re concerned about decisions made by an attorney, deputy or guardian on behalf of the person they are appointed for.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on raising performance concerns when a coronavirus (COVID-19) test product is impacted by a variant of concern (VOC) or other emerging variant (V).
These published standards relate to Corporate Priority 3 – Regulatory Service.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
These published standards relate to a number of KPIs in the VMD Deliverables and KPI document.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How we assess issues of potential regulatory concern
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Raising a concern including Whistleblowing Policy and Procedure.
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