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How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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.
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
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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.
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
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.
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
Information for applicants in England about the outcome of the national Clinical Impact Awards (NCIAs) 2023 and the appeals process.
How to use a cost effectiveness analysis to evaluate your digital health product.
Information about the awards process for applicants, employers, assessors and award holders.
How to use a clinical audit to evaluate your digital health product.
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