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.

Documents

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

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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

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