Chart re-abstraction
SECONDARY
The site research team will re-abstract a subsample of their hospital charts and assess the error rate. Re-abstraction will focus on critical data elements related to the primary and secondary objectives of the protocol. The number of charts to be re-abstracted for each 6-month interval will be based on the number of patients who enroll in the study during the 6-month period at each site as shown in Table Chart re-abstractionThe DCC will provide sites with the randomly selected subject IDs for re-abstraction. The site research team will identify an independent site Quality Control (QC) abstractor who will re-abstract and enter data into the EDC only for the QC process and will not abstract study data while QC activities are taking place. The DCC will generate a discrepancy report comparing study data abstracted by the site with the source information abstracted by the independent QC abstractor. The site manager will hold a QC Review Meeting with the independent site QC abstractor, study coordinator, and site abstractor(s) to review the discrepancies and identify errors. Together they will discuss and document the corrective action for each error identified. The DCC will create manual queries in the EDC to make any necessary corrections to the data that were identified during the QC Review Meeting. The research team will provide hospitals that have an error rate above the predefined threshold (five errors per review) with additional training, a hospital-specific assessment of the data collection process, and suggestions for process improvement. The research team will track hospitals by their error rates. The research team will share practices of those hospitals with exceptionally low error rates with hospitals working to improve their own process. The trial subcommittee will review error rates and re-abstraction data during monthly team calls. If errors exceed five errors per review, on two consecutive reviews, a remediation plan will be requested and shared with the study sponsor.