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How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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 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 investigators and sponsors should manage clinical trials during COVID-19
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
How to use an ethnographic study to evaluate your digital health product.
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.
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 to use a before-and-after study to evaluate your digital health product.
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.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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