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Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The full government response to the Lord O'Shaughnessy independent review of UK commercial clinical trials.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Final report of the independent review of UK commercial clinical trials, and government response.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
How investigators and sponsors should manage clinical trials during COVID-19
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
This is a report on the main findings of the review and recommended actions.
Actions that trial sponsors should consider to build resilience into clinical trial design
How to use a randomised controlled trial to evaluate your digital health product.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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