Oversight and monitoring of investigational medical product trials

Name: Oversight and monitoring of investigational medical product trials
Creator: Medicines and Healthcare products Regulatory Agency
License: https://www.nationalarchives.gov.uk/doc/open-government-licence/version/2/
Keywords: clinical-trials,examples,guidances,monitoring,sponsors,statistical,thermometers

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Health And Social Care

Published

January 28, 2022

Last updated

January 28, 2022

Description

To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.

Organization

Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧

Country / Region

United Kingdom

License

Open Government Licence 2.0 (United Kingdom)

Feedback

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2 Main files

Oversight and monitoring activities

Updated on January 28, 2022

html

URL: https://www.gov.uk/government/publications/oversight-and-monitoring-of-investigational-medical-product-trials/oversight-and-monitoring-activities
Permalink: https://data.openrid.co/en/datasets/r/7d7a5d82-8b19-4edf-b8c6-3d74a78bd10a
MIME Type: text/html

Created on: January 28, 2022
Modified on: January 28, 2022

Example where Centralised Statistical Monitoring detected mis-calibrated thermometers in a clinical trial