# Clinical investigations: statistical considerations

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/5203359f-3b0f-4bee-8769-91ba740d7979
Type: Guidance
Published: March 30, 2026

> How to make sure that you are providing the statistical data required as part of a clinical investigation of your medical device.

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## Content

This guidance helps manufacturers to understand the statistics that should be included as part of the data gathered during a clinical investigation. It includes information about: clinical investigation design conduct and monitoring phase follow-up and reporting safety issues

## Attachments

- [Statistical considerations](/government/publications/clinical-investigations-statistical-considerations/statistical-considerations)