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)

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)

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

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

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

Branching

Logic

Scheduling

API

Data

Dictionary

Data

Validation

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?