Frequency and plans for auditing trial conduct {23}
RECRUITMENT
Inspections of the ongoing or already completed study can be carried out by the respective competent authorities in accordance with the applicable legislation. In addition, sponsor’s representatives can conduct monitoring and audits at participating institutions at any time as part of quality assurance.Monitoring includes initiation, regular on-site, and close-out visits. Monitoring will be carried out by appropriately trained clinical research associates according to the standard operating instructions of the responsible clinical research organization (KKS Halle, Martin-Luther-University Halle-Wittenberg, Germany). Frequency of regular and interim visits will depend on the study monitoring plan, recruitment rate, study compliance, and findings from previous visits. Principal investigators or the institutions involved will give the monitor/auditor access to all documents necessary for review.