Transcript REDCap Introduction

REDCap Introduction
By
J Kevan Essmyer
Acknowledgements:
Paul Harris (Vanderbilt CTSA)
Jack Baty (WUSM REDCap Admin)
Overview
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What is it…
Where is it…
What are the costs…
REDCap Features (A brief tour of the system)…
Getting Started (Creating a REDCap project)…
Demonstration…
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 data “cleaning” effort during analysis.
REDCap System
(What is it?)
• Easy to use, web based Research data capture system
• Metadata (Form) driven data store development
• Generic clinical data system with adaptable features
covering Surveys, Cross-sectional, and longitudinal
study models
• Provides data validation at time of entry, and user
based data access restrictions.
• Provides easy mechanism to view and export data in a
variety of formats for common analysis tools.
• Designed to be a self service tool
WUSM REDCap Installation
WHERE IS IT
http://project-redcap.org/
REDCap Consortium
WUSM REDCap Installation
• Active installation since November 2009
• Currently have 1200+ users
• System hosted on local secure WU servers
behind multiple firewalls
• Daily differential backup
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.
– File size currently limited to 32MB per file
• No limit on the number of projects per study.
• Basic technical support and usage guidance provided by
REDCap adminstators.
A brief tour of the system
REDCAP SELECTED FEATURES
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
Study Calendar – Participant Scheduling
Participant Scheduling Module Optional
Visit-Level View Shows Status + CRFs (Longitudinal Model)
Online Form Designer
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.
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
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(
(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))
)
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”
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)
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
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
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
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
Data Import Tools
Use Cases: Convert DB to REDCap Batch Data Uploads
Project File Repository
Project-Specific Files Uploaded Here
Project-Specific Files Downloaded Here
Data Export Files Auto-Saved
Data Quality Module (Data Queries)
Results
Data Quality Module (data queries)
Expanded API Functionality
Audit Trails / Data Logging
Full Audit Logs – Data Changes and Page Views
Top-Down and In-Line Video Training Resources
Built-in User derived FAQ Resource
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
Getting Started
• Submit Request forms
– User , Project, and or Sidedoor “off -campus” 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
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
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.
“?!!?”
User Rights
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
REDCap Email Support
[email protected]
REDCap Goals
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Easy to use
Metadata Driven
Adaptable Features
Data entry validation
Self service tool
Questions?