redcap version 5. 6.x by j kevan essmyer acknowledgements: paul harris (vanderbilt ctsa) jack baty...
TRANSCRIPT
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..– 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
REDCap
Publications
Researcher
Statistical Analysis
Write Conclusion
Define Forms/Data
Define Procedure/Events
Set User Access
Capture Data
Query/Correct Data
Spreadsheet/
Custom DB
Find Problem
Fix Problem
Eventually$$$
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
File Server
Host Server
WEB Server
Uploaded Files
Installation Files
https://redcap.biostat.wustl.ed
u
Data Entry / Admin / Surveys
MySQL Server
MySQL Slave Server
Data
Sync
Biostatistics Secure DomainPublic 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
Existing 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 • 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 multi-site
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 ChecklistProvides a general to-do list during project creation
Create hyperlinks to web pages or other REDCap projects
Select Cross-sectional or LongitudinalProject Data Model
--Online Designer
--Link to REDCap Shared Library
--Enable optional project features
Cross-sectional and LongitudinalProject 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 OptionalVisit-Level View Shows Status + CRFs (Longitudinal Model)
Multiple Surveys ProjectsSurvey Server
Event 1-First Form
Anonymous Link
Participant List Invitation
Creates Participant Record
Follow Up Surveys
Designated Email Field
Participant List Email Address
Adds Data to Existing Record
Multiple Surveys Per Event
Asynchronous Requests
Scheduled Email
Logic TriggerDataEvent
Schedule
Unique Survey URL
Automated Survey Invitation Conditions
Data Visualization / Cleaning
Data Export + De-ID Tools
Exports RawData + StatsScript Files(Labels, Coding
EmbeddedDe-IdentificationTools
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
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.
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)
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)
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 CuratedInstruments
Annotated Records
View as Web Page or PDF
If coming from REDCap,May import to your study
Scheduled for ReleaseApril, 2010
Treatment Randomization Module
GETTING STARTEDCreating a REDCap project
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
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
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– [[email protected]]– Monitored by 4 to 5 Administrators
Top-Down and In-Line Video Training Resources
Built-in User derived FAQ Resource
REDCap Email Support
REDCap Goals
• 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
Data Quality Module (data queries)
Expanded API Functionality
REDCap Setup Tools (Instantiate New Project ~ 15 sec)
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.
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)
GETTING STARTEDCreating a REDCap project
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
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)