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How to apply for a clinical trial (prior to 28 April 2026) including eligibility, phases, model IMPDs, costs and how to make changes to your application.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
Information relating to good clinical practice (GCP) inspections.
Guidance on the various types of modifications that can be made to a clinical trial approval.
As with all clinical trials, the MHRA’s top priority is the safety and wellbeing of the trial participants.
This guidance is intended to support individuals interested in conducting a field trial, including the application submission process.
How to use a randomised controlled trial to evaluate your digital health product.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Guidance on the process for ending a clinical trial.
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