We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Requirements for sponsor representatives using EHR (electronic health records) in clinical trials.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidance for NHS trusts carrying out clinical trials and organisations sponsoring a trial to ensure electronic health record systems are compliant.
Patients benefit from earlier access to technologies that could improve or save lives, as the MHRA approved 17 per cent more clinical investigations in 2025 compared with 2024, and launches measures to support innovation and growth.
How investigators and sponsors should manage clinical trials during COVID-19
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to use a clinical audit to evaluate your digital health product.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab and requires JavaScript).