Basics of Quality Management in CT

Inspections are another check of all trial related activities, but they are conducted by the regulatory authority(ties) and are as such not part of the quality management which is planned by the sponsor. However, if an inspection is performed, it will ensure and typically increase the quality of a trial by flagging short-comings and requiring corrective actions.

‘The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial. They may be located at the site of the trial, at the sponsor's and/or contract research organisations (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).’

As with audits, inspections may also be performed on a ‘for-cause’ basis if, for instance, the clinical trial is part of the documentation for a new medicine. They may also be performed simply by chance as a part of a routine control. Following an inspection of a trial the sponsor will receive an inspection report stating all the details that have been examined and the ‘findings’ that have been made by the inspectors.

The findings will be graded into ‘minor’, ‘major’ and ‘critical’. ‘Critical’ findings are those that actually have put participant safety, participant rights or the trial result at a considerable risk. The inspection report will outline what requirements the inspectors have made for the trial. In the worst case, an inspector may suspend or even terminate a trial.