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. Define Procedure/Events
Researcher
REDCap
Define Forms/Data
Define Procedure/Events
Find Problem
Fix Problem
Spreadsheet /
Custom DB
Set User Access
Capture Data
Query/Correct Data
$$$
Eventually
Write Conclusion
Statistical Analysis
Publications

5. General Purpose Data Base with Clinical Bias
Web Surveys
Activity Logging
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, , 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. Case Report Form / Activity Panel
Left Panel User
Control Menus
Case Report Form / Activity Panel

10. Project Setup Checklist
Provides a general to-do list during project creation
Select
Cross-sectional or Longitudinal Project 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 Longitudinal Project 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
Anonymous Link
Participant List Address
Participant List Invitation
Designated Field
Scheduled
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) Units Date Formats
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]," ","h","mdy",true)
Units
"y"
years
1 year = days
"M"
months
1 month = days
"d"
days
"h"
hours
"m"
minutes
"s"
seconds
"ymd"
Y-M-D (default)
"mdy"
M-D-Y
"dmy"
D-M-Y
Date Formats

28. REDCap Shared Form Library

29. Demo Survey

30. Creating a REDCap project
Getting StaRTed

31. 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
Test Forms
Define
Study Events
(Longitudinal)
add Schedule (optional)
Data Entry
Forms
Add Users
and
Set User Rights

32. Web-Based Project Creation
Point/Click Drag (Ajax)
For Real-time
CRF Creation
Longitudinal CRF Mapping
Optional Participant
Scheduling Setup Screens

33. Public HTTPS Survey Access WUSM Secure Campus Network
Biostatistics Secure Domain
wustl.edu
File Server
Uploaded Files
MySQL Server
Data
Data Entry / Admin / Surveys
WEB Server
Sync
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: [
User Account—per 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 Support

38. REDCap Goals Questions? 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  (
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)  (

40. You’ve Gone Past the last Slide!
…A Slide Too Far
STOP!
You’ve 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 Curated Instruments
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."