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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
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.
Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
How to use a randomised controlled trial to evaluate your digital health product.
How investigators and sponsors should manage clinical trials during COVID-19
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
Actions that trial sponsors should consider to build resilience into clinical trial design
Information on clinical trials for medicines, how to apply for authorisation in the UK, how to manage your authorisation, reporting safety issues and details about the MHRA phase I accreditation scheme.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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