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

REDCap Home Screen

Databases you have access to:

Training Resources

• Videos and some examples– Overview– Creating data forms– Scheduling Module– Types of Databases– Data access groups– Locking records

• “General Help & FAQs”

Setting up a Project

Example of Data Entry Form

Online Form Designer

Adding a field

Data Comparison Tools

Data Logging (Audit trail)

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

REDCap Calendar

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)

Report Builder – Creating Report

Report Builder - Result

REDCap Graphical View

REDCap Stats

Citing REDCap