Table 1.

Procedures at the CDC Data Management Center and local sites during different stages of registry development and implementation for the assurance of data quality (modified from Arts et al., 2002)

CDC Data Management Center	Local clinic sites
Registry onset SB Registry elements finalized and data collection forms developed by participating clinicians and CDC SB team staff. Data and data characteristics defined. Data collection and data audit protocols developed.	Registry onset Clinic site staff member designated by Principal Investigator to manage data quality assurance. Site staff reviewed overview of study, abstraction procedures, data collection procedure, and progress reports. Clinic site study staff participated in training for data entry and edit using the SB-EMR.
Implementation Edit checks embedded in SB-EMR. Report functionality embedded in SB-EMR to prevent transmission of reports with missing data. User friendly data abstraction forms developed. Data quality assurance plan developed.	Implementation System to monitor reliability and completeness of data designed and implemented. Clinic staff determined the validity and completeness of data from data extraction sources such as medical records.
Ongoing Continuous communication/encouragement conducted with sites. Forms, software, data dictionary, protocol, training material, etc., amended when indicated. Data transmitted via the secure data transmission network logged and tracked for transmission errors. Regular conference calls convened with SB registry data committee. During site visits: data quality audit conducted comparing central registry data with source data, causes of discrepancies discussed, local data collection and entry procedures observed. Automatic data checks performed and site-specific data quality reports generated. Data quality reports provided to sites. Causes of data errors resolved and local correction of data errors facilitated.	Ongoing New clinic staff/chart abstractors trained. Data collection/entry staff and PIs communicated frequently. Data definitions reviewed with all staff as indicated. Functionality of updated software application evaluated and issues reported. CDC informed regarding any issue/concern regarding the data. SB EMR application report screens analyzed for missing and inaccurate data. Case counts reviewed by using the application’s analytic function, eWebReports ‘Exago, Inc., Shelton, CT’. Accuracy and completeness of data validated via a bimonthly review by another person (20% records) for 3 months when data-entry staff persons join the project. Investigated errors detected at local sites and in quality reports from the Data Management Center.
Future A large scale reliability study in all sites will be conducted in 2013.	Future Participate in reliability study.

CDC, Centers for Disease Control and Prevention; SB, spina bifida; PI, XXX; SB-EMR, Spina Bifida-Electronic Medical Record.