Frequency and plans for auditing trial conduct {23}
Each participating site will perform internal quality management of study conduct, data and biospecimen collection, documentation, and case report form completion. An individualized quality management plan and report will be developed to describe a site’s performance. As per standard practices, prior to the start of participant enrollment, site research staff will receive extensive training in the study’s protocol. Quality control and reliability of screening, baseline data collection, and follow-up will be monitored by the EDC. The results will be shared with the study Executive Committee, and site research coordinators and investigators, via monthly study teleconferences.Quality assurance will be accomplished in several ways under supervision of the EDC.Enrollment metrics: site research team members will enter screening data into the study database. This will enable the EDC to determine the number of patients who qualified for enrollment, the number who met exclusion criteria, and the number who declined to participate in the study.Data quality: completeness of participant data will be monitored by the EDC utilizing a real-time data query system, which identifies data deficiencies daily. Sites will receive daily reports on the number of outstanding data queries.Retention metrics: participant retention data will be analyzed, and the EDC will issue monthly site-specific reports on participant follow-up success rates.Adherence to IRB/REB requirements: participant IDs will randomly be selected, and regulatory documents will be reviewed on a regular basis by the EDC. Specific details are described in the risk-based monitoring plan.Accuracy of collected data: assessment of entered data accuracy will be performed during site audits.Site monitoring: a risk-based monitoring plan will be followed to ensure overall data quality, maximize detection of non-compliance and/or quality issues, and verify adequate investigator oversight. Findings will be assessed for severity, impact, prevalence, and actions taken by the site to address any concerns identified. The site monitor will communicate findings with each site to ensure understanding and compliance of the protocol and address concerns in a timely and appropriate manner.If quality assurance issues are detected, the site PIs, project managers, and EDC staff will work collaboratively to address these issues. Participating sites will provide direct access to all trial source data/documents and reports for the purpose of monitoring and auditing by the sponsor and inspection by local and regulatory authorities, as required.