Discrepancy Management
Discrepancy management involves identifying and resolving discrepancies or inconsistencies in the data collected during the study to ensure data accuracy, reliability, and integrity. Our data management team compare the information recorded in case report forms (CRFs) or electronic case report forms (eCRFs) with the source documents, such as patient medical records or laboratory reports. Discrepancies can arise from data entry errors, missing information, inconsistencies, or deviations from the study protocol. Each identified discrepancy is documented, categorized, and recorded in a discrepancy tracking system. This documentation includes details of the discrepancy, its nature, the source of the discrepancy, and its potential impact on the study data. Our data management personnel collaborate with clinical trial site staff, investigators, or study monitors to resolve discrepancies. A timeline for resolving discrepancies is established, and data management teams may follow up with the clinical trial sites to ensure that corrections or clarifications have been made promptly. The discrepancy management process adheres to quality control standards to maintain the highest data quality. Any unresolved discrepancies or data errors can impact the credibility and validity of the clinical trial results. Every action taken to resolve discrepancies is thoroughly documented. This documentation serves as an audit trail, providing transparency and accountability in the data management process.
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