REDCap Version 5.6.X
By
J Kevan Essmyer
Acknowledgements:
Paul Harris (Vanderbilt CTSA)
Jack Baty (WUSM REDCap Admin)
Left Panel User
Control Menus
Case Report Form / Activity Panel
647 Consortium Partners
Why Use REDCap?
• Provides researchers a tool that..
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Defines forms/data
Controls user access to data
Captures data entry
Validates fields
Checks/Queries data
Stores data
Exports data for analysis
…Researchers are good people, give them a good
tool and they will do good things….
--Paul Harris Vanderbilt
Researcher
REDCap
Define Forms/Data
Define Procedure/Events
Set User Access
Fix Problem
Capture Data
Spreadsheet
/
Custom DB
Query/Correct Data
$$$
Find Problem
Write Conclusion
Statistical Analysis
Publications
Current Usage Costs
• Offered as an Investigator Resource for Washington
University Institute of Clinical and Translational
Sciences(ICTS) and Siteman Cancer Center (SCC) members.
• No charge for data or file storage.
– Individual upload file size currently limited to 32MB per file
– No limit on number of upload files
• No limit on the number of projects per study.
• Basic technical support and usage guidance provided by
REDCap administrators.
– Study design and analysis services provided via appropriate
Division of Biostatistics Consulting Mechanisms
Public HTTPS Survey Access
Biostatistics Secure Domain
https://redcap.biostat.
wustl.edu
File Server
Sync
MySQL Server
WEB Server
MySQL Slave Server
Host Server
WUSM REDCap Servers
(http://www.biostat.wustl.edu/redcap)
Development “Trying it Out”
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HIPAA Secure server
REDCap User Request form (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 “Data Collection”
•
REDCap Project Request form (Fax or
email)
– Sponsoring PI
– IRB Approval or Waiver
– Only PI or Project Admin can
create projects
•
Production “Status”
– Data Dictionary
• Changes saved
• Review of submitted
changes to avoid unintended
data corruption
• Delete all records function
disallowed
Existing REDCap Features
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Calendar Scheduling tool
Online Graphical Form designer
Multiple data types supported
Built-in data validation for
special text fields (phone,
email, SSN, numeric, …etc.)
Branching Logic to conditionally
show/hide fields
Calculation Fields
Configurable user permission
levels
Record Locking
Record Change Confirmation
• Report Builder
• Graphical data viewing tool
• Simple data Import / Export
mechanism
• Data quality query system for
checking data integrity
• API interface for integration
with other data systems.
• Detailed logging routines for
monitoring data creation,
modification, deletion and
viewing.
• Integrated software
instructions, FAQ, video
tutorials.
Features --Continued
• User Rights Templates
• User grouping for multisite data access restrictions
• Double Data Entry support
• Project Templates
• Variable Piping
• Data queries
– Data Error Detection
– Data Resolution Work Flow
• Curated Shared Forms
Library
• Treatment Randomization
Module
• Multiple Surveys
• Survey scheduler
– Logic/Event/Data driven
• Data entry triggers
– Automated program calls
Data Import Tools
Use Cases: Convert DB to REDCap Batch Data Uploads
Data Export Tools
Use Cases: Export data with pre-built import syntax file
Project Setup Checklist
Provides a
general to-do
list during
project creation
Select
Cross-sectional or
Longitudinal
Project Data Model
--Online Designer
--Link to REDCap
Shared Library
--Enable optional
project features
Create hyperlinks
to web pages or
other REDCap
projects
Cross-sectional and Longitudinal
Project Data Models
Templates
Templates
• Several default templates will be available
immediately.
• Projects can be modified once created.
Record Status Dashboard
Record Status Dashboard
Study Calendar – Participant Scheduling
Participant Scheduling Module Optional
Visit-Level View Shows Status + CRFs (Longitudinal Model)
Multiple Surveys Projects
Unique Survey URL
Survey Server
Event 1-First Form
Follow Up Surveys
Anonymous Link
Participant List Email Address
Participant List Invitation
Designated Email Field
Scheduled Email
Creates
Participant Record
Logic Trigger
Data
Event
Schedule
Adds Data to Existing Record
Multiple Surveys Per Event
Asynchronous Requests
Automated Survey Invitation
Conditions
Custom Reports
End-User Creation/Use of Custom Reports
Reports
Data Visualization / Cleaning
Data Export + De-ID Tools
Embedded
De-Identification
Tools
Exports Raw
Data + Stats
Script Files
(Labels, Coding
Online Form Designer
Data Dictionary Spreadsheet
• Combine/edit project forms
• Share forms with other investigators
• Access same metadata and functionality as the online designer tool
Field Types
Textbox Data Validation
Branching Logic Creation Tool
Calculations
Calculations are preformed on
the web browser during data
entry. Form must be submitted
to saved in the project data.
Calculated field should be
considered a form tool. All
calculations should be re-applied
by statistical software during
formal analysis/reporting phase.
Built in Functions
DATEDIFF F(x)
Type of calculation
Notes / examples
round(number,decimal
places)
Round
roundup(number,decimal
places)
Round Up
rounddown(number,deci
mal places)
Round Down
sqrt(number)
Square Root
datediff([date1], [date2], "units", "dateformat",
returnSignedValue)
datediff([dob],[date_enrolled],"d")
datediff([dob],"05-31-2007","h","mdy",true)
Units
"y"
years
1 year = 365.2425
days
"M"
months
1 month = 30.44
days
(number)^(exponent)
Exponents
abs(number)
Absolute Value
"d"
days
min(number,number,...)
Minimum
"h"
hours
max(number,number,...)
Maximum
"m"
minutes
mean(number,number,...
)
Mean
"s"
seconds
median(number,number,.
..)
Median
sum(number,number,...)
Sum
stdev(number,number,...)
Standard Deviation
Date
Formats
"ymd"
Y-M-D (default)
"mdy"
M-D-Y
"dmy"
D-M-Y
User Permissions “Rights”
User Roles
Define custom roles for different user types (Data entry, PI, Monitor…)
Supporting Multi-Site
• Data Access Group Partitions
• Double Data Entry
– Standard and modified usage
• SSL enabled Secure Server for Internal and
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
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 Comparison Tools
Use Case: Double-Data Entry Studies
DDE Merge Tool
Project File Repository
Project-Specific Files Uploaded Here
Project-Specific Files Downloaded Here
Data Export Files Auto-Saved
Data Quality Module (Data Queries)
Audit Trails / Data Logging
Full Audit Logs – Data Changes and Page Views
Shared Library (Consortium)
Public Consortium Site
Search Curated
Instruments
Scheduled for Release
April, 2010
Annotated Records
View as Web Page or PDF
If coming from REDCap,
May import to your study
Treatment Randomization Module
Creating a REDCap project
GETTING STARTED
BEST Practices
• Consider carefully the amount of data to collect per visit, per event, and overall
in every clinical trial
• Avoid crowding questions
• Consider the use of closed versus open systems (i.e., forced-choiced questions)
• Use consistent units of measurement
• Avoid requiring the respondent to make calculations whenever possible
• Avoid mixing timeframes in a single section
• Consider the consequences of creating incomplete or inadequate data
collection forms
• Collect relevant information to address trial objectives at the time of the trial
• Differentiate between Unknown, Uncertain, and Missing data instead of using
the phrase "Not Available“
– Spilker and Schoenfelder
• also give a list of the following helpful pointers which they believe, "refer to issues to consider
to assess whether the point is relevant to a particular clinical trial."
Getting Started
• Submit Request forms
– User and/or Project access request forms
• Create Project
– Select Usage, Type, Data Model, and Scheduling option
• Create Forms
– Online designer to graphically create forms
– Spreadsheet template for advance and large form changes
– Forms per event designations
• User Rights
– Data access, Import/Export Rights, Data Access Groups
– Form level access
• Tests forms (Thorough testing will help avoid deployment delays)
• Move to Production “Status”
• Start Collecting Data.
Project Creation Flow Chart
Create Project
–Project Name, Longitudinal or
Cross-Sectional/ Survey
Move to Production
Status and start
Data Collection
Excel Spreadsheet
Or
Online Form
Designer
Data Entry
Forms
Add Users
and
Set User
Rights
Define
Study Events
(Longitudinal)
add Schedule
(optional)
Web-Based Project Creation
Point/Click
Drag (Ajax)
For Real-time
CRF Creation
Longitudinal
CRF Mapping
Optional
Participant
Scheduling
Setup Screens
Move to Production Status
• Production Status on the Production Server
• Data dictionary changes are stored by the
system
• Global deletion of data from system
prohibited
• Changes to forms must be approved by
Administrators before they are committed to the
project.
• Changes to the Forms/ Event Grid must be
preformed by the Administrators.
WUSM HIPAA Compliance
• Password protected User accounts
– Customizable User Permissions
• SSL encrypted data transmissions
– Browser   Server
• Detailed Activity Logs
– Data Creation/Update/Deletion/Views/Downloads
• Data Access Groups
– Limit users data access specific groups of Participants
REDCap Lifelines
• Built-in tutorial videos
• Built-in Frequently Asked Question (FAQ)
guide
• Demonstration Databases (Some Online, more
to come, on demand)
• WUSM Biostat REDCap Email Help Queue
– [redcap@rt.biostat.wustl.edu]
– Monitored by 4 to 5 Administrators
Top-Down and In-Line Video Training Resources
Built-in User derived FAQ Resource
REDCap Email Support
redcap@rt.biostat.wustl.edu
REDCap Goals
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Easy to use
Metadata Driven
Adaptable Features
Data entry validation
Self service tool
Questions?
Acknowledgements
• Siteman Cancer Center Member
– The Alvin J. Siteman Cancer Center at Barnes-Jewish
Hospital and Washington University School of Medicine
( http://www.siteman.wustl.edu/about-us.aspx#sthash.spgPKuBy.dpuf)
• Institute of Clinical and Translational Sciences Member
– The Clinical and Translational Science Award program,
funded by the National Center for Advancing
Translational Sciences (NCATS), a part of the National
Institutes of Health (NIH)
(http://http://icts.wustl.edu/)
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
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
Results
Data Quality Module (data queries)
Expanded API Functionality
REDCap Setup Tools (Instantiate New Project ~ 15 sec)
Project Setup Checklist
Provides a
general to-do
list during
project creation
Create hyperlinks
to web pages or
other REDCap
projects
All users
permissions for
data access
configured here
User Permissions “Rights”
Online Form Designer
First data element
in the first form is
consider the study
ID
Variable names
must be in lower
case and cannot be
repeated in the
data dictionary
regardless of which
form it is on.
File-Based Project Creation
Project Data Dictionary
•Spreadsheet contains all the meta data necessary for REDCap to create data
forms
•Quick transfer or modification of forms
•Moving forms between REDCap Servers
•Complicated Form modifications
•Adding or removing multiple fields
•Move fields from one form to another
Forms Ready for Data
REDCap CRF
Record Locking
• Records can be lock by designated
users to prevent further data entry
change to specified forms
• ***WUSM Software installation is
not currently configured for serving
as a electronic source document
system. (FDA 21 CFR Part 11 Electronic Records compliant)
Creating a REDCap project
GETTING STARTED
Calculations
• Simple
• [weight]*10000/([height]*[height])
• Complex
• Calculating the Mean of groups with null valid range includes zero
The following equation will calculate the Mean of a list of variables
•
(
(if(Math.abs([A])>0,[A],0))
+(if(Math.abs([B])>0,[B],0))
+(if(Math.abs([C])>0,[C],0))
)
/
(
(if(Math.abs([A])>0,1,if([A]=0,1,0))
+if(Math.abs([B])>0,1,if([B]=0,1,0))
+if(Math.abs([C])>0,1,if([C]=0,1,0))
)
Project Creation Flow Chart
Create Project
–Project Name, Longitudinal or
Cross-Sectional/ Survey
Move to Production
Status and start
Data Collection
Excel Spreadsheet
Or
Online Form
Designer
Data Entry
Forms
Add Users
and
Set User
Rights
Define
Study Events
(Longitudinal)
add Schedule
(optional)