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How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How investigators and sponsors should manage clinical trials during 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.
Actions that trial sponsors should consider to build resilience into clinical trial design
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
The Advisory Committee on Clinical Impact Awards (ACCIA) advises health ministers on the presentation of clinical impact awards to consultants working in the NHS. ACCIA is an advisory non-departmental public body, sponsored by the Department of Health and Social Care...
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.
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.
How to use a clinical audit to evaluate your digital health product.
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
Application form for a licence to conduct a clinical trial using an animal medicine (animal test certificate).
Information for applicants in England about the outcome of the National Clinical Impact Awards 2022.
Information for applicants in England about the outcome of the national Clinical Impact Awards (NCIAs) 2023 and the appeals process.
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