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Detailed guidance, regulations and rules
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Data, Freedom of Information releases and corporate reports
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
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.
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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How investigators and sponsors should manage clinical trials during COVID-19
Actions that trial sponsors should consider to build resilience into clinical trial design
Guidance on transitional arrangements for applying for clinical trial approval.
Clinical trial applications that need expert advice from a specialist group or committee.
Guidance on the process for ending a clinical trial.
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