Abstract
BackgroundHistorically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes.Methods and Principal FindingsThe National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. We characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions.ConclusionsHistorically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks.
Highlights
Research sponsors and clinical research organizations (CROs) are transitioning from paper-based data collection to electronic data capture (EDC) systems
Data quality for paper-based clinical trials is traditionally assessed through audits that compare database listings against data recorded on paper case report forms (CRFs), thereby providing an estimate of the database error rate [13,14]
An audit plan was applied to trials conducted at the network’s data and statistical center (DSC) that opened to enrollment after April 2005 and used Webbased Electronic Data Capture (EDC), excluding trials that were migrated to the center
Summary
Research sponsors and clinical research organizations (CROs) are transitioning from paper-based data collection to electronic data capture (EDC) systems. Few new data collection systems or methodologies, with the exception of electronic patient reported outcomes (ePRO) [1–12], are wellcharacterized with respect to data quality. Data quality for paper-based clinical trials is traditionally assessed through audits that compare database listings against data recorded on paper case report forms (CRFs), thereby providing an estimate of the database error rate [13,14]. Only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
