REDCap Version 6.1.X
By
J Kevan Essmyer
Acknowledgements:
Paul Harris, (Vanderbilt CTSA)
Phil Miller, (Biostatistics Division Faculty Sponsor)
Jack Baty, (WUSM REDCap Admin)
Yu Tao, (WUSM REDCap Admin)
Ningying Wu, (WUSM REDCap Admin)
1243 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
General Purpose Data Base with
Clinical Bias
Web Surveys
Activity Logging
PDF of Blank or
Completed forms
Data
Import / Export
De-Identified
Data Export
Data Forms
User
Management
Data Access Groups /
Multi-Site Access
Custom Reports
REDCap Project
Data Quality Queries /
Resolution
API Interface /
Custom Programs
REDCap Application
(Hosts Multiple
REDCap Projects)
PHI Field Restriction
Formatted Export
(SAS, SPSS, R, Excel)
Branching /
Skip Logic
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
• Multiple Databases 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
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
Left Panel User
Control Menus
Case Report Form / Activity Panel
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
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
Templates
• Several default templates will be available
immediately.
• Projects can be modified once created.
• Templates created from Existing projects
Record Status Dashboard
Study Calendar – Participant Scheduling
Participant Scheduling Module Optional
Visit-Level View Shows Status + CRFs (Longitudinal Model)
Multiple Surveys Per Project
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
User Permissions “Rights”
Custom Reports
End-User Creation/Use of Custom Reports
Custom Reports
End-User Creation/Use of Custom Reports
Data Visualization / Cleaning
Online Form Designer
Field Types
Data Dictionary Spreadsheet
• Combine/edit project forms
• Share forms with other investigators
• Access same metadata and functionality as the online designer tool
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
REDCap Shared Form Library
http://projectredcap.org
Demo Survey
Creating a REDCap project
GETTING STARTED
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
Public HTTPS Survey Access
WUSM Secure Campus Network
Biostatistics Secure Domain
File Server
https://redcap. wustl.edu
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
– Sponsoring PI
– Username /password
– Open access to the Demo server
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Off-campus Access
– Access from any “capable”
Internet connection (world wide)
• No Active Surveys!
• No Production “Status”!
Production “Data Collection”
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REDCap Project Request form
– Sponsoring PI
– IRB Approval or Waiver
– Only PI or Project Admin can
create projects
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Production “Status”
– Data Dictionary
• Changes saved
• Review of submitted
changes to avoid unintended
data corruption
• Delete all records function
disallowed
Getting Started
• Submit Account Requests: [http://www.biostat.wustl.edu/redcap/?page_id=43]
– User Account—per person
– Project Account – designate PI/PA per Study
• 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
• Set Security 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.
Top-Down and In-Line Video Training Resources
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…(User Driven)
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/)
…A Slide Too Far
STOP!
You’ve Gone Past the last Slide!
….Backup
Extra Slides
Textbox Data Validation
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)
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
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."