Guidance

Oversight and monitoring of investigational medical product trials

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 28 January 2022

Documents

Oversight and monitoring activities

HTML

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

PDF, 572 KB, 3 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email [email protected]. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

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

The sponsor’s oversight and monitoring can be regarded to encompass all the activities undertaken by the sponsor during the conduct of the trial that are there to ensure the participants rights and wellbeing are protected, the reliability of the trial data and hence the trial results and that the trial is conducted in accordance with the legislation. It is the sponsor’s “safety net” to check that the trial protocol, procedures, training etc. that have been implemented in order to get it right first time are functioning correctly.

Published 28 January 2022