REDCap - Biostatistics

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REDCap Version 5
By
K. Essmyer
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….
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
Public HTTPS Survey Access
Biostatistics Secure Domain
WEB Server
File Server
Authenticated Access
Sync
MySQL Server
WU Campus
Sidedoor
Server
Data Entry /Admin
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”
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REDCap Project Request form (Fax or
email)
– 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
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 administators.
– 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
User grouping for multi-site data
access restrictions
Double Data Entry support
• 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.
• Curated Shared Forms Library
• Treatment Randomization Module
New Features
• Projects
– Templates
– Expanded Automated Design Change Approvals in
Production Mode
– Project Deletion-30 Day delay option
– Record Status Dashboard
– Data entry trigger
• Surveys
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Multiple Surveys Per project
Survey Email Scheduler
Response Driven Survey
Participant Email Field
Project Templates
• Create new project based on existing
templates
• REDCap Administrator can create templates as
requested.
• Templates open for general use by all users
with project creation rights.
Templates
Templates
• Several default templates will be available
immediately.
• Projects can be modified once created.
Expanded Automated Design
Change Approvals in Production Mode
• Data field changes will only be considered
critical if
– Data has already be entered into the field for the
project
– Multiple choice fields, changes to options that
have not been selected in the project will no
longer be flagged as critical.
– Built in email tool for requesting change
verification.
Project Deletion-30 Day delay option
• Deleted projects may now be restored at any
time within 30 days of their "deletion".
• Immediate deletion available via REDCap
Administrator request
Record Status Dashboard
Record Status Dashboard
Data Entry Trigger
• Automated HTTP Post to URL Address
– Form Submitted Trigger
– Record ID | Form | Event |Form Completed Status
– Not Activated by Data import
– Remote system must determine appropriate
response to data trigger
Data Entry Trigger
REDCap Server
Actions
• Pre-determined
• Notifications…
• Rule based
• Query Project
for Condition
• (API)
Data trigger event occurs
on every form submission
Remote System
REDCap Surveys
Multiple Surveys Projects
• First Form must be enabled as Survey
– Anonymous Survey
– Participant Invitation List
• Follow Up Surveys
– Existing Record
– Participant List or Designated Email address Field
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
Online Designer Changes
• Enable instrument as survey
• Survey instructions and Acknowledgements.
• Automated invitation conditions
– Event specific
Automated Survey Invitation
Conditions
Survey Participant Management
• New survey activity log view page
– Date Time invitation was sent
– Survey/Event
– Response Status
– Invitation Status
Survey Participant Email
• Use designated field to capture/enter email
address for future survey invitations
• Participant List email address supersedes
email field
• Enable in Project Setup
• Survey not the First Instrument of the Project.
– Participant List cannot only be used
– Participant record must exist
Creating a REDCap project
FEATURE CHANGES
Alternate “From” Email Address
• Add up to 2 alternate email address.
• Primary email address used by REDCap for
alerts and notifications
Logic Restrictions
• Tighter logic and F(x) restrictions
– Branching Logic
– Calculated Fields
– Data Queries
• Barred use of Javascript Libraries
– Only Built-in REDCap Functions may be used
• Legacy queries exempt unless security issue detected
• Rules apply to New or Updated equations
• Why???
– More secure and easier to debug equation errors.
Creating a REDCap project
GETTING STARTED
Getting Started
• Create Project (On Production Server)
– Select Usage
– Cross-sectional or longitudinal
– Options: Scheduling, Existing Template
• 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)
“?!!?”
User Rights
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
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
• Phil Miller
– Director of ………many……many…things……………
– ……………………, and the WUSM REDCap Installation
• REDCap Administrators
– Jack Baty
[redcap@rt.biostat.wustl.edu]
– Yu Tao
[redcap@rt.biostat.wustl.edu]
– Ningying Wu [redcap@rt.biostat.wustl.edu]
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