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How to use a quasi-experimental study to evaluate your digital health product.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
How to use a feasibility study when planning the evaluation of your digital health product.
Guidance on the pre-examination stage for Nationally Significant Infrastructure Projects.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use routinely collected data to evaluate your digital health product.
Guidance on the examination stage for Nationally Significant Infrastructure Projects.
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.
Details of eligibility requirements and the application process for the mainstream scheme, the route through which most people join.
The purpose of this report is to present some descriptive statistics and related analysis of the 2012–13 survey data
How the UK's strategic export controls apply to academics, university researchers and their institutions, and when an export licence is needed.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guide to submitting research applications to the Administration of Radioactive Substances Advisory Committee (ARSAC).
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on the pre-application stage for Nationally Significant Infrastructure Projects.
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