1. REDCap at UVM Presented by Diantha Howard, CCTS Biomedical Informatics
September 2011

2. What is REDCap
Software and methodology for electronic data collection and management
REDCap database and REDCap Survey
(REDCap database)
(REDCap survey only)
Written in PhP using a MySQL database.
One product, but here we have 2 instances – REDCap database behind FAHC firewall. The survey implementation needs to NOT be behind firewall so at UVM.

3. REDCap History 2004: Started at Vanderbilt GCRC
2006: Consortium started
2011: 250 Institutional Partners
World-wide
From CTSA, GCRC, RCMI and other institutions
Over 20,000 studies with over 29,000 end-users
9/6/11: 255 partners; 20,530 studies; 29,270 end-users

4. 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
The underlying database is backed up nightly (both by Biomedical Informatics and FAHC IS).
21 CFR Part 11 Capable:
Records can be “locked”; e-signatures can be required.

5. REDCap Home Screen
REDCap administrator (me) creates username. User gets from REDCap with URL, user name, & temporary password.

6. Databases you have access to:
Development: can make changes in real-time. Can enter test data which will be deleted when move to production.
Production: all changes must be approved by Administrator

7. Example of Data Entry Form

8. REDCap Calendar

9. Data Export and Import Data Export Tool: Data Import 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
De-identification options: remove all identifiers, shift dates, remove “unvalidated” text fields (i.e. not numbers, dates, etc.), remove dates, remove notes fields

10. Data Comparison Tools
Can compare any two records. Fields with differences appear. Can click on value to edit it. For double-data entry module, ability to merge both records into one.

11. Data Logging (Audit trail)
When you set up the database, you can specify that a reason must be entered if any data are changed. These reasons then show up on the “logging” page.

12. 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)
File Repository: So can keep snapshot of data exported at certain time (e.g. for interim analysis). It automatically keeps copies of all exported files & syntax!
Rights: whether they can modify forms, import or export data; access to logging, reports, file repository, user rights, etc. Users will only see (on left menu) functions they have.
Data Access Group: If a user not in a group, they can access data entered by any access group. Can also use this for double-data entry by assigning each data-entry person to a separate group.
Report Builder: Can filter data, sort, choose which fields to display.
Send-It (Don’t really need at UVM). Can upload a file <= 2MB and specify (multiple) s for recipients. They receive with link to download. (could use for easily sending exported data or documents to multiple people.)

13. Report Builder – Creating Report

14. Report Builder - Result

15. REDCap Graphical View
For choice variables, gives bar graph of frequencies.
{For numeric variables, gives median & quartiles, (as well as actual values)} Now just median & actual values – if click on point can go to that record
Note: for longitudinal studies, unfortunately this combines all events.
Note ** This is designed more for data cleaning/ quality than for analysis.
So you can see outliers, check how many forms still incomplete, etc.

16. REDCap Stats
Again, for longitudinal studies, this combines events.

17. Training Resources Videos and some examples “General Help & FAQs”
Overview
Creating data forms
Scheduling Module
Types of Databases
Data access groups
Locking records
“General Help & FAQs”
Some contextual help also. I.e. in online form editor.
Note: Videos are sometimes from a different version of REDCap, so some minor differences.
Help & FAQ tab when you log-in, or in bottom of left menu column.

18. Citing REDCap
Consortium requests that REDCap be cited. (Language on ccts web page – under Biomedical Informatics – REDCap)