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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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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 investigators and sponsors should manage clinical trials during COVID-19
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 carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Actions that trial sponsors should consider to build resilience into clinical trial design
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.
The full government response to the Lord O'Shaughnessy independent review of UK commercial clinical trials.
Application form for a licence to conduct a clinical trial using an animal medicine (animal test certificate).
We are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines
Points to consider when using real-world data in clinical studies
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to use a crossover randomised controlled trial to evaluate your digital health product.
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