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 New Secure Server (External Access) features in the REDCap 4.8 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) Public HTTPS Access Biostatistics Secure Domain WEB Server File Server Authenticated Access Sync MySQL Server WUCON Sidedoor Server Data Entry /Admin WEB Server MySQL Slave Server Host Server PROJECT CREATION FLOW CHART Create Project –Project Name, Longitudinal or Cross-Sectional/ Survey Excel Spreadsheet Or Online Form Designer Data Entry Forms Move Move to Production to StatusProduction on Production Server and start Data Status and start Data Collection Collection Add Users and Set User Rights Define Study Events (Longitudinal) add Schedule (optional) Study Calendar – Participant Scheduling Participant Scheduling Module Optional Visit-Level View Shows Status + CRFs (Longitudinal Model) Audit Trails / Data Logging Full Audit Logs – Data Changes and Page Views 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) 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 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) CREATING DATA ACCESS GROUPS Add Group to Study Add User to Group Only one Group per user 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 USER PERMISSIONS “RIGHTS” 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 Data Comparison Tools Use Case: Double-Data Entry Studies DDE MERGE TOOL Public HTTPS Access Biostatistics Secure Domain WEB Server File Server Authenticated Access Sync MySQL Server WUCON Sidedoor Server Data Entry /Admin WEB Server MySQL Slave Server Host Server 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. 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!!!! 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 EXPANDED API FUNCTIONALITY EXPANDED FIELD VALIDATION TYPES DATA QUALITY MODULE (DATA QUERIES) DATA QUALITY MODULE (DATA QUERIES) EXTERNAL LINKS Embed hyperlinks in the REDCap project menu. Websites, Other REDCap Projects, web tools DATA SEARCH TOOL 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 “?!!?” User Rights REDCAP LIFELINES 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 REDCAP EMAIL SUPPORT redcap@rt.biostat.wustl.edu QUESTIONS?