Frequency and plans for auditing trial conduct {23}
CRF
CRF
For quality assurance, monitoring audits will be performed. An independent local monitor will perform the monitoring.Monitoring visits will be conducted to review study plan compliance, compare CRFs and individual patients’ medical records, perform an accounting of study material, and ensure that the study is conducted according to applicable regulatory requirements. CRF entries will be verified with source documentation. Monitoring visits will be performed repeatedly for at least all 6 months and check at least 10% of the signed ICFs.