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This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Information and guidance on a range of medical devices for users and patients.
How to use a cost effectiveness analysis to evaluate your digital health product.
Actions that trial sponsors should consider to build resilience into clinical trial design
Information on the diagnosis, prevention and treatment of human parainfluenza viruses (HPIVs).
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
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 to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Review of the clinical pathway used in the dental pilot programme makes a number of recommendations to improve the pathway approach.
The Brucella Reference Unit (BRU) provides laboratory diagnostic and clinical management services for Brucella species.
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