In addition to clinical monitoring and other quality control measures, the performance of audits is one of the key activities in the quality management of your clinical study. As shown in the pyramid below, an auditor complements the activities in continuous quality control by taking on a more detached position and observing the events from a higher vantage point. Audits during study conduct need to be planned beforehand and will in most cases result in observations that need careful follow-up.

Key Considerations for Sponsors:

Audit planning:

       The planning of an audit program either for a single or a set of clinical studies should be based on risk assumptions. It is advisable to assess potential risks early-on and to integrate these insights into the planning of the audits. If you as a sponsor, for example, conduct your study in a new indication or an indication, where clinical studies are rare, in-process audits of investigational sites are highly recommendable. The audit program should include instructions for action in case the planned audits result in major or critical observations.

Being ready for “for cause”:

       Despite all planning, the unexpected will happen. Situations may arise in the cooperation with your subcontractors and vendors or with the investigational sites, that require further information and in-depth root cause analyses. In these cases, an (unplanned) “for cause” audit might be necessary to collect the missing information. Even in the rare case of suspected fraud, a preceding audit should be a regular step in the procedure to assess accusations. Finally, in case an inspection is given notice, the preparation of the inspection with the help of an auditor seems essential.

Follow-up of observations:

       (Nearly) No audit without observations. Generally speaking, audit observations are either connected to data or processes. It is important to understand the significance of process-related audit observations, as these will be the basis for potential improvement. Audit observations should therefore always be linked to a thorough root cause analysis and resulting corrective and preventive actions, the so-called CAPA.

In conclusion, audits are important for the quality management of clinical studies. From planning based on risk assumptions to being prepared for ‘for cause’ situations, and following up on observations, each step is crucial. Understanding the significance of process-related audit observations can improve the quality of your clinical study.

Audit planning is an important part of quality management and should be adapted to the identified risks in a study-specific manner!

With the help of our team you can count on audit preparation, QMS gap analysis, Site, system & vendor qualification audits. Contact us today!

Autor: Dr. Christoph Ortland, January 2024