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How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
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.
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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
You can use the PRE service to view recordings of pre-recorded evidence before trial.
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.
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.
Actions that trial sponsors should consider to build resilience into clinical trial design
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