using redcap to support multi-site trials at wusm
DESCRIPTION
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) - PowerPoint PPT PresentationTRANSCRIPT
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
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)
File Server
Host Server
WEB Server
Uploa
ded
Files
Installation
Files
WEBServer
WUCON
Sidedoor Server
https://redcapsurvey.wustl.edu...
REDCap Survey
Data Entry
/Admin
Data Entry /Admin
MySQL Server
MySQL Slave Server
Data
Sync
Biostatistics Secure Domain
Authenticated Access
Public HTTPS Access
PROJECT CREATION FLOW CHART
Create Project –Project Name, Longitudinal or Cross-Sectional/ Survey
Excel Spreadsheet
Or Online Form
Designer
Data EntryForms
Add Users and
Set User RightsTest
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
Study Calendar – Participant Scheduling
Participant Scheduling Module OptionalVisit-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)
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
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
File Server
Host Server
WEB Server
Uploa
ded
Files
Installation
Files
WEB Server
WUCON
Sidedoor Server
https://redcapsurvey.wustl.edu...
REDCap Survey
Data Entry
/Admin
Data Entry /Admin
MySQL Server
MySQL Slave Server
Data
Sync
Biostatistics Secure Domain
Authenticated Access
Public HTTPS Access
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
EXTERNAL LINKS
Embed hyperlinks in the REDCap project menu. Websites, Other REDCap Projects, web tools
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
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
[[email protected]] Monitored by 4 to 5 Administrators