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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
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 investigators and sponsors should manage clinical trials during COVID-19
Guidance on transitional arrangements for the Clinical Trials Regulations.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
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.
Guidance on clinical trials that are categorised as ‘notifiable’.
Actions that trial sponsors should consider to build resilience into clinical trial design
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