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How investigators and sponsors should manage clinical trials during COVID-19
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.
Monitoring significant occupational exposures to HIV, hepatitis B and hepatitis C in healthcare workers, and advising on avoiding injuries.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Actions that trial sponsors should consider to build resilience into clinical trial design
Advice to help lower the chance of passing mpox infection to others during post-exposure vaccination clinics.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
A supplementary consultation on disbursements within the fixed recoverable costs scheme for clinical negligence claims up to a value of £25,000 in England and Wales.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Proposes the introduction of fixed recoverable costs and a new streamlined process in clinical negligence claims up to a value of £25,000 in England and Wales.
The scheme will see the lowest-risk clinical trials processed by the MHRA in less than 14 days.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
You may be able to pay no Customs Duty or a reduced amount of duty for goods you bring or receive into the UK, depending on what they are and what you do with them.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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.
Don’t include personal or financial information like your National Insurance number or credit card details.
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