# Oversight and monitoring of investigational medical product trials

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/30597e5d-3f21-4d0d-b825-b67a0c40f13c
Type: Guidance
Published: January 28, 2022

> Requirements and recommendations for sponsors and those conducting trials.

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## Content

UK legislation requires that the sponsor assures themselves that the trial is being conducted according to: the principles of GCP the legislation the authorisation from the competent authority the favourable opinion from the ethics committee the trial protocol and procedures Oversight and monitoring encompass all the activities the sponsor carries out during the trial to ensure that: the participants’ rights and wellbeing are protected the trial data and hence the trial results are reliable the trial is conducted in accordance with the legislation

## Attachments

- [Oversight and monitoring activities](/government/publications/oversight-and-monitoring-of-investigational-medical-product-trials/oversight-and-monitoring-activities)
- [Example where Centralised Statistical Monitoring detected mis-calibrated thermometers in a clinical trial](https://assets.publishing.service.gov.uk/media/61d40849e90e07196b24c7f2/Cluepoints_Example_1.pdf)