Audits are part of a sponsor’s established quality assurance and quality control system. The aim of a sponsor’s audit is to determine - independently and separate from routine monitoring and other quality control measures - whether the evaluated trial-related activities were conducted according to protocol, to the sponsor’s standard operating procedures (SOPs), the GCP Guidelines and applicable regulatory requirements.
The ZKS’s auditors are certified, qualified and experienced in the conduct of audits according to ZKS’s standard operating procedures.
Audits in the context of UKM sponsorship
ZKS Münster performs audits for investigator-initiated trials conducted under the sponsorship of the UKM. For further information see also section “Sponsorship”.
Support in the preparation and post-processing of audits and inspections
The ZKS provides consulting and support for UKM’s own trial sites in the preparation and post-processing of announced audits by external sponsors and inspections by authorities.