1. U SING REDC AP TO S UPPORT M ULTI -S ITE T RIALS AT WUSM By Kevan Essmyer Special Thanks to Jack Baty

2. M ULTI - SITE S UPPORT WUSM REDCap Installation (Brief Overview) Data Access Groups Double Data Entry Standard and modified usage Sidedoor Secure Server (External Access) New features in the REDCap 4.8

3. N EED FOR D ATA C APTURE S OFTWARE Convenient uniform data entry method Stateless web-based Secure WUSM HIPAA compliant centralized data store. Easy to use multi-purpose clinical database Not Excel, Not Access, Not 3-4 composition notebooks somewhere on the top shelf Reduce costly data “cleaning” effort during analysis. (WUSM Best Practices Guidelines)WUSM Best Practices Guidelines

4. File Server Host Server WEB Server Uploaded Files Installation Files WEB Server WUCON Sidedoor Server https://redcapsurvey.wustl.edu... REDCap Survey Data Entry /Admin MySQL Server MySQL Slave Server Data Sync Biostatistics Secure Domain Authenticated Access Public HTTPS Access

5. P ROJECT C REATION F LOW C HART Create Project –Project Name, Longitudinal or Cross-Sectional/ Survey Excel Spreadsheet Or Online Form Designer Data Entry Forms Add Users and Set User Rights Test Forms Move to Production Status and start Data Collection Define Study Events (Longitudinal) add Schedule (optional) Move to Production Status on Production Server and start Data Collection

6. Study Calendar – Participant Scheduling Participant Scheduling Module Optional Visit-Level View Shows Status + CRFs (Longitudinal Model)

7. Audit Trails / Data Logging Full Audit Logs – Data Changes and Page Views

8. D EVELOPMENT S ERVER “T RYING IT O UT ” http://www.biostat.wustl.edu/redcap REDCap User Request forms (Fax or email) Sponsoring PI Username /password Open access to the Development server Off-campus Access Sidedoor security certificate Access from any “capable” Internet connection (world wide)

9. P RODUCTION S ERVER “R EAL D ATA ” http://www.biostat.wustl.edu/redcap REDCap Project Request form (Fax or email) Sponsoring PI IRB Approval or Waiver Only PI or Project Admin can create projects Production “Status” on the Production Server Data Dictionary Changes saved Review of submitted changes to avoid unintended data corruption Delete all records function disallowed

10. D ATA A CCESS G ROUPS Partition data records among groups of users Each group can only see the data associated with the group they belong to. Each user can only belong to one group “Global” users can be created for cross site management. (i.e. Any user not restricted to a Group)

11. C REATING D ATA A CCESS G ROUPS Add Group to Study Add User to Group Only one Group per user

12. D ATA A CCESS G ROUP D ATA E NTRY Users only have access to their groups data. !!!Users Not assigned to a group have access to all records according to their “User Rights”!!! Multiple accounts available for Study Managers

13. U SER P ERMISSIONS “R IGHTS ”

14. D OUBLE D ATA E NTRY M ODULE Standard method Supports only two data entry participants per REDCap Project Option for those creating individual project for each site Modified usage Create duplicate record with “comparison” or prefix/postfix Use comparison tool to compare records. Any user with data entry rights can do DDE

15. Data Comparison Tools Use Case: Double-Data Entry Studies

16. DDE M ERGE T OOL

17. File Server Host Server WEB Server Uploaded Files Installation Files WEB Server WUCON Sidedoor Server https://redcapsurvey.wustl.edu... REDCap Survey Data Entry /Admin MySQL Server MySQL Slave Server Data Sync Biostatistics Secure Domain Authenticated Access Public HTTPS Access

18. S IDEDOOR S ECURE S ERVER Provides external access to the WUSM REDCap web interface to certified users. Required Supervisor approved request form. Individual SSL certificates issue to each user. Constitutes ½ of the required HIPAA keys for accessing the REDCap data system. (Separate from REDCap username and password) Web based certificate, allows global access with sufficiently capable internet connection.

19. S IDEDOOR S ECURE S ERVER Provides access to both the Development and Production servers. Certificates self-signed by WUSM Biostatics Department Require a security exception be added to web browser (Simple click yes to approve option on webpage) May require IT tech support to get installed on restricted systems. Expiration Date Revocable Not to be shared among multiple users!!!!

20. N EW FEATURES IN THE REDC AP 4.8 Improved API functionality Expanded Field validation types Data Quality Module (data queries) External Links functionality REDCap Plugin capabilities Data Search Tool

21. E XPANDED API F UNCTIONALITY

22. E XPANDED F IELD V ALIDATION T YPES

23. D ATA Q UALITY M ODULE ( DATA QUERIES )

25. E XTERNAL L INKS Embed hyperlinks in the REDCap project menu. Websites, Other REDCap Projects, web tools

26. D ATA S EARCH T OOL

27. S UPPORTING M ULTI -S ITE Data Access Group Partitions Double Data Entry Standard and modified usage Sidedoor Secure Server for External Campus access Configurable Individual “User Rights” Multiple access levels System Access –granted by the REDCap Administrators Project Access –granted by Project Administrator User Rights –set by Project Administrator

28. “?!!?” User Rights Branching Logic Scheduling API Data Dictionary Data Validation

29. REDC AP L IFELINES Built-in tutorial videos Built-in Frequently Asked Question (FAQ) guide Demonstration Databases (Some Online, more to come) WUSM Biostat REDCap Email Help Queue [redcap@rt.biostat.wustl.edu] Monitored by 4 to 5 Administrators

30. REDC AP E MAIL S UPPORT redcap@rt.biostat.wustl.edu

31. Q UESTIONS ?