REDCap Introduction
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REDCap Introduction By J Kevan Essmyer Acknowledgements: Paul Harris (Vanderbilt CTSA) Jack Baty (WUSM REDCap Admin)
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REDCap Introduction. By J Kevan Essmyer Acknowledgements: Paul Harris (Vanderbilt CTSA) Jack Baty (WUSM REDCap Admin). Overview. What is it… Where is it… What are the costs… REDCap Features (A brief tour of the system) … Getting Started (Creating a REDCap project) … - PowerPoint PPT Presentation
Transcript of REDCap Introduction
REDCap Introduction
By J Kevan Essmyer
Acknowledgements:Paul Harris (Vanderbilt CTSA)
Jack Baty (WUSM REDCap Admin)
Overview
• 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
WHERE IS ITWUSM REDCap Installation
REDCap Consortium
http://project-redcap.org/
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
File Server
Host Server
WEB Server
Uploaded Files
Installation Files
WEB Server
WU Campus
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 Survey Access
WUSM REDCap Servers(http://www.biostat.wustl.edu/redcap)
Development “Trying it Out”
• 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
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.
REDCAP SELECTED FEATURESA brief tour of the system
REDCap Features• 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 OptionalVisit-Level View Shows Status + CRFs (Longitudinal Model)
CalculationsCalculations 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
•((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
"y" years 1 year = 365.2425 days
"M" months 1 month = 30.44 days
"d" days
"h" hours
"m" minutes
"s" seconds
"ymd" Y-M-D (default)
"mdy" M-D-Y
"dmy" D-M-Y
Type of calculation Notes / examples
round(number,decimal places) Round
roundup(number,decimal places) Round Up
rounddown(number,decimal places) Round Down
sqrt(number) Square Root
(number)^(exponent) Exponents
abs(number) Absolute Value
min(number,number,...) Minimum
max(number,number,...) Maximum
mean(number,number,...) Mean
median(number,number,...) Median
sum(number,number,...) Sum
stdev(number,number,...) Standard Deviation
datediff([date1], [date2], "units", "dateformat", returnSignedValue)
datediff([dob],[date_enrolled],"d")
datediff([dob],"05-31-2007","h","mdy",true)
Units
Date Formats
DATEDIFF F(x)
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 Export + De-ID Tools
Exports RawData + StatsScript Files(Labels, Coding
EmbeddedDe-IdentificationTools
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
Audit Trails / Data Logging
Full Audit Logs – Data Changes and Page Views
Shared Library (Consortium)Public Consortium Site
Search CuratedInstruments
Annotated Records
View as Web Page or PDF
If coming from REDCap,May import to your study
Scheduled for ReleaseApril, 2010
GETTING STARTEDCreating a REDCap project
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
Excel SpreadsheetOr
Online Form Designer
Data EntryForms
Add Users and
Set User Rights
Test
Forms
Move to Production Status and start Data Collection
Define Study Events
(Longitudinal)
add Schedule (optional)
Web-Based Project Creation
Point/ClickDrag (Ajax)For Real-timeCRF Creation
Optional ParticipantSchedulingSetup Screens
LongitudinalCRF Mapping
Project Setup ChecklistProvides 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 DesignerFirst 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.
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
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– [[email protected]]– Monitored by 4 to 5 Administrators
REDCap Goals
• Easy to use• Metadata Driven • Adaptable Features• Data entry validation• Self service tool
Questions?
