Guidance

Oversight and monitoring of investigational medical product trials

Requirements and recommendations for sponsors and those conducting trials.

• 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

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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

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

Published 28 January 2022