Site Data Monitoring and Quality Control Sample Clauses

Site Data Monitoring and Quality Control. ‌ Study coordinators or investigators at each clinical site will perform primary data collection based on source-documented hospital chart reviews. Case Report Forms will be submitted to data management in an expedited fashion. To ensure proper tracking of Case Report Forms and test reports obtained from the individual clinical sites, a master tracking system will be utilized. Deficiencies identified by the master tracking system and any other specific clinical sites needs will be communicated regularly. In addition, regularly scheduled teleconferences between the Study Coordinator(s) for each site and the sponsor may occur. All clinical sites will be monitored periodically by the sponsor’s personnel, or sponsor’s designee, for protocol adherence, accuracy of CRF completion, and compliance to applicable regulations. Ongoing and/or serious non-compliance with respect to these standards will be evaluated and appropriate corrective/preventive actions required will be determined. If corrective/preventive actions are not subsequently undertaken, the clinical sites will be asked withdraw from the study.‌
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Related to Site Data Monitoring and Quality Control

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  • PERFORMANCE MONITORING AND REPORTING Performance indicators

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