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Using REDCap to Support Multi-Site Trials at WUSM

Using REDCap to Support Multi-Site Trials at WUSM. By Kevan Essmyer Special Thanks to Jack Baty. Multi-site Support. WUSM REDCap Installation (Brief Overview) Data Access Groups Double Data Entry Standard and modified usage Sidedoor Secure Server (External Access)

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Using REDCap to Support Multi-Site Trials at WUSM

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  1. Using REDCap to Support Multi-Site Trials at WUSM By KevanEssmyer Special Thanks to Jack Baty

  2. Multi-site Support • 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. Need for Data Capture Software • 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)

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

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

  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. Development Server“Trying it Out” • 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. Production Server“Real Data” • 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. Data Access Groups • 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. Creating Data Access Groups • Add Group to Study • Add User to Group • Only one Group per user

  12. Data Access Group Data Entry • 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. User Permissions “Rights”

  14. Double Data Entry Module • 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 Merge Tool

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

  18. Sidedoor Secure Server • 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. Sidedoor Secure Server • 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. New features in the REDCap 4.8 • Improved API functionality • Expanded Field validation types • Data Quality Module (data queries) • External Links functionality • REDCap Plugin capabilities • Data Search Tool

  21. Expanded API Functionality

  22. Expanded Field Validation Types

  23. Data Quality Module (data queries)

  24. Data Quality Module (data queries)

  25. External Links • Embed hyperlinks in the REDCap project menu. • Websites, Other REDCap Projects, web tools

  26. Data Search Tool

  27. Supporting Multi-Site • 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. “?!!?” Branching Logic Data Validation User Rights API Data Dictionary Scheduling

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

  30. REDCap Email Support redcap@rt.biostat.wustl.edu

  31. Questions?

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