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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 investigators and sponsors should manage clinical trials during COVID-19
Following MHRA approval of a clinical trial, a study on Nuwiq, a recombinant FVIII therapy for the treatment of haemophilia A, can proceed.
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.
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.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Actions that trial sponsors should consider to build resilience into clinical trial design
Details of dates when trials are likely to take place at the Chancery division of the High Court.
How to use a randomised controlled trial to evaluate your digital health product.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to use a micro-randomised trial to evaluate your digital health product.
How to use a factorial randomised controlled trial to evaluate your digital health product.
Guidance and reports on the Department for Transport's trial of longer semi-trailers for articulated goods vehicles.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
A complete list of 5G projects involved in the 5G Testbeds and Trials Programme
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.
Complete this form when a restricted patient needs to be transferred to another secure hospital.
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