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Good Practices in Data Management (e.g. Redcap). Presented by Diantha Howard, CCTS Biomedical Informatics December 2012. Goals of Data Management. Consistent Accurate Securely stored (including, but not limited to HIPAA issues) Attributable (i.e. “who entered”) Accessible for analysis.
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Good Practices in Data Management(e.g. Redcap) Presented by Diantha Howard, CCTS Biomedical Informatics December 2012
Goals of Data Management • Consistent • Accurate • Securely stored (including, but not limited to HIPAA issues) • Attributable (i.e. “who entered”) • Accessible for analysis
What is REDCap • Software and methodology for electronic data collection and management • REDCap database and REDCap Survey • http://project-redcap.org/ • https://apollo.pantheon.fletcherallen.org/redcap • (REDCap database) • https://ccts.uvm.edu/redcap • (REDCap survey only)
REDCap History • 2004: Started at Vanderbilt GCRC • 2006: Consortium started • 2012: 511 Institutional Partners • World-wide (48 countries in 2012) • From CTSA, RCMI and other institutions • Over 53,400 studies with over 71,000 end-users
Advantages of REDCap • Secure, web-based, with authentication and data-logging • Free to REDCap Consortium members (UVM CCTS is a member) • Fast and flexible to design and implement • Multi-site access (here through FAHC gateway) • Exports data & syntax to common stat packages (SPSS, SAS, Stata, R/S-Plus) • 21 CFR Part 11 Capable
Training Resources • Videos and some examples • Overview • Creating data forms • Scheduling Module • Types of Databases • Data access groups • Locking records • “General Help & FAQs”
Data Export and Import • Data Export Tool: • Select all or certain fields from all or certain forms • De-identification options • Export data to a .csv file or • Export data and syntax for SAS, SPSS, R, Stata • Data Import Tool: • Download template (.csv) once database created • Enter data into template and upload back to REDCap • For Longitudinal study, each event must be imported separately
Randomization Module • Enabled when creating project, or by modifying project settings • Can be stratified by fields in your data, or within Data Access Groups • You create allocation scheme, then upload to REDCap, which then will assign subjects
More REDCap Applications • File Repository • Can upload and retrieve documents and files • E.g. Consent forms; exported data & syntax • Rights administration • You can assign rights to users on your study • Global rights: Import/ export / reporting / database design • Read/ edit/ no access (on form-by-form basis) • Data Access Groups • For Multi-site trials; users can only see data entered by their access group • Report Builder • Create and save simple queries/ reports • “Send-It” (Secure File Transfer)