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How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to meet the good clinical practice standards for clinical trials and what to expect from an inspection.
How to use a cost effectiveness analysis to evaluate your digital health product.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to use a clinical audit to evaluate your digital health product.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use a before-and-after study to evaluate your digital health product.
Good clinical practice (GCP) referrals received by the MHRA for 2011 to 2020.
Guidance on licencing and best use of radiopharmaceuticals and sealed radioactive sources in diagnosis, treatment or research.
The MHRA has today launched a public consultation on the revised ICH guideline on Good Clinical Practice.
How to use a cost utility analysis to evaluate your digital health product.
How investigators and sponsors should manage clinical trials during COVID-19
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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