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How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
Guidance for NHS trusts carrying out clinical trials and organisations sponsoring a trial to ensure electronic health record systems are compliant.
How to use a quasi-experimental study to evaluate your digital health product.
How to use a combination of quantitative and qualitative data to evaluate your digital health product.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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.
MHRA performance metrics for clinical trials and established medicines assessment.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
Application form for a licence to conduct a clinical trial using an animal medicine (animal test certificate).
The authors explore this assertion from the perspective of a pre-exposure prophylaxis trial to prevent HIV in South Africa
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