1. Good Practices in Data Management (e.g. Redcap) Presented by Diantha Howard, CCTS Biomedical Informatics December 2012

2. Goals of Data Management Consistent Accurate Securely stored (including, but not limited to HIPAA issues) Attributable (i.e. “who entered”) Accessible for analysis

3. 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)

4. 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

5. 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

6. REDCap Home Screen

7. Databases you have access to:

8. Training Resources Videos and some examples – Overview – Creating data forms – Scheduling Module – Types of Databases – Data access groups – Locking records “General Help & FAQs”

9. Setting up a Project

10. Example of Data Entry Form

11. Online Form Designer

12. Adding a field

13. Data Comparison Tools

14. Data Logging (Audit trail)

15. 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

16. REDCap Calendar

17. 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

18. 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)

19. Report Builder – Creating Report

20. Report Builder - Result

21. REDCap Graphical View

22. REDCap Stats

23. Citing REDCap