REDCap Version 6.1.X

1
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)
2
1243 Consortium Partners
3
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

4
Researcher
Define Forms/Data

Write Conclusion
Publications
Statistical Analysis
5
General Purpose Data Base with Clinical Bias
Activity Logging
Web Surveys
PDF of Blank or Completed forms
Data Import / Export
De-Identified Data Export
Data Forms
User Management
Data Access Groups / Multi-Site Access
REDCap Project
Custom Reports
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
6
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

7
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.

8
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

9
(No Transcript)
10
Project Setup Checklist
Provides a general to-do list during project
creation
Select Cross-sectional or LongitudinalProject
Data Model
--Online Designer --Link to REDCap Shared
Library --Enable optional project features
Create hyperlinks to web pages or other REDCap
projects
11
Cross-sectional and LongitudinalProject Data
Models
12
Data Import Tools
Use Cases Convert DB to REDCap Batch Data
Uploads
13
Data Export Tools
Use Cases Export data with pre-built import
syntax file
14
Templates

• Several default templates will be available
  immediately.
• Projects can be modified once created.
• Templates created from Existing projects

15
Record Status Dashboard
16
Study Calendar Participant Scheduling
Participant Scheduling Module Optional Visit-Level
View Shows Status CRFs (Longitudinal Model)
17
Multiple Surveys Per Project
Survey Server
Unique Survey URL
Event 1-First Form
Follow Up Surveys
Participant List Email Address
Anonymous Link
Participant List Invitation
Designated Email Field
Scheduled Email Logic Trigger Data Event Schedule
Creates Participant Record
Adds Data to Existing Record Multiple Surveys
Per Event Asynchronous Requests
18
User Permissions Rights
19
Custom Reports
End-User Creation/Use of Custom Reports
20
Custom Reports
End-User Creation/Use of Custom Reports
21
Data Visualization / Cleaning
22
Online Form Designer
23
Field Types
24
Data Dictionary Spreadsheet

• Combine/edit project forms
• Share forms with other investigators
• Access same metadata and functionality as the
  online designer tool

25
Branching Logic Creation Tool
26
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.
27
Built in Functions
DATEDIFF F(x)
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)
"y" years 1 year 365.2425 days
"M" months 1 month 30.44 days
"d" days
"h" hours
"m" minutes
"s" seconds
Units
"ymd" Y-M-D (default)
"mdy" M-D-Y
"dmy" D-M-Y
Date Formats
28
REDCap Shared Form Library
http//projectredcap.org
29
Demo Survey
30
Getting StaRTed

• Creating a REDCap project

31
Project Creation Flow Chart
Move to Production Status and start Data
Collection
Excel Spreadsheet Or Online Form Designer
Test Forms
Define Study Events (Longitudinal) add
Schedule (optional)
Data Entry Forms
Add Users and Set User Rights
32
Web-Based Project Creation
Point/ClickDrag (Ajax) For Real-time CRF Creation
LongitudinalCRF Mapping
Optional Participant SchedulingSetup Screens
33
Public HTTPS Survey Access
WUSM Secure Campus Network
Biostatistics Secure Domain
https//redcap. wustl.edu
File Server
MySQL Server
Uploaded Files
Data
Data Entry / Admin / Surveys
Sync
WEB Server
MySQL Slave Server
Installation Files
Host Server
34
WUSM REDCap Servers(http//www.biostat.wustl.edu/
redcap)

• Development Trying it Out
• HIPAA Secure server
• REDCap User Request form
• Sponsoring PI
• Username /password
• Open access to the Demo server
• Off-campus Access
• Access from any capable Internet connection
  (world wide)
• No Active Surveys!
• No Production Status!

• Production Data Collection
• REDCap Project Request form
• 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

35
Getting Started

• Submit Account Requests http//www.biostat.wustl
  .edu/redcap/?page_id43
• User Accountper 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.

36
Top-Down and In-Line Video Training Resources
37
REDCap Email Support
redcap_at_rt.biostat.wustl.edu
38
REDCap Goals

• Easy to use
• Metadata Driven
• Adaptable Features
• Data entry validation
• Self service tool(User Driven)
• Questions?

39
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.aspxsth
  ash.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/)

40
A Slide Too Far

• STOP!
• Youve Gone Past the last Slide!
• .Backup

41
Extra Slides
42
Textbox Data Validation
43
User Roles
Define custom roles for different user types
(Data entry, PI, Monitor)
44
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

45
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)

46
Project File Repository
Project-Specific Files Uploaded Here
Data Export Files Auto-Saved
Project-Specific Files Downloaded Here
47
Data Quality Module (Data Queries)
48
Audit Trails / Data Logging
Full Audit Logs Data Changes and Page Views
49
Shared Library (Consortium)
Public Consortium Site
Search CuratedInstruments
Scheduled for Release April, 2010
Annotated Records
View as Web Page or PDF
If coming from REDCap, May import to your study
50
Treatment Randomization Module
51
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."