1. REDCap Introduction By J Kevan Essmyer Acknowledgements:
Paul Harris (Vanderbilt CTSA)
Jack Baty (WUSM REDCap Admin)

2. 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…

3. 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.

4. 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

5. WUSM REDCap Installation
Where is it

6.
REDCap Consortium

7. WUSM REDCap Installation
Active installation since November 2009
Currently have users
System hosted on local secure WU servers behind multiple firewalls
Daily differential backup

8. Biostatistics Secure Domain
Public HTTPS Survey Access
Biostatistics Secure Domain
WEB Server
File Server
REDCap Survey
Uploaded Files
MySQL Server
Authenticated Access
Data
WEB Server
Sync
WU Campus
Data Entry /Admin
MySQL Slave Server
Data Entry /Admin
Sidedoor Server
Installation Files
Host Server

9. WUSM REDCap Servers (http://www.biostat.wustl.edu/redcap)
Development “Trying it Out”
HIPAA Secure server
REDCap User Request form (Fax or )
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 )
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

10. 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.

11. REDCap Selected Features
A brief tour of the system
REDCap Selected Features

12. 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
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

13. Study Calendar – Participant Scheduling
Participant Scheduling Module Optional
Visit-Level View Shows Status + CRFs (Longitudinal Model)

14. Online Form Designer

15. Field Types

16. Textbox Data Validation

17. Branching Logic Creation Tool

18. 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.

19. 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)) )

20. 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

21. User Permissions “Rights”

22. 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)

23. 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

24. 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)

25. Creating Data Access Groups
Add Group to Study
Add User to Group
Only one Group per user

26. 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

27. 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

28. Data Comparison Tools
Use Case: Double-Data Entry Studies

29. DDE Merge Tool

30. Custom Reports
End-User Creation/Use of Custom Reports

31. Reports

32. Data Visualization / Cleaning

33. Data Export + De-ID Tools
Embedded De-Identification Tools
Exports Raw Data + Stats
Script Files
(Labels, Coding

34. Data Import Tools
Use Cases: Convert DB to REDCap Batch Data Uploads

35. Project File Repository
Project-Specific Files Uploaded Here
Data Export Files Auto-Saved
Project-Specific Files Downloaded Here

36. Data Quality Module (Data Queries)

37. Results

38. Data Quality Module (data queries)

39. Expanded API Functionality

40. Audit Trails / Data Logging
Full Audit Logs – Data Changes and Page Views

41. Top-Down and In-Line Video Training Resources

42. Built-in User derived FAQ Resource

43. 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

44. Treatment Randomization Module

45. Creating a REDCap project
Getting StaRTed

46. Getting Started Submit Request forms Create Project Create 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.

47. 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

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

49. REDCap Setup Tools (Instantiate New Project ~ 15 sec)

50. 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

51. User Permissions “Rights”

52. 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.

53. File-Based Project Creation

54. 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

55. Forms Ready for Data

56. REDCap CRF

57. 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.

58. “?!!?” Branching Logic Data Validation User Rights API Data Dictionary
Scheduling
Data Dictionary

59. REDCap Lifelines Built-in tutorial videos
Built-in Frequently Asked Question (FAQ) guide
Demonstration Databases (Some Online, more to come)
WUSM Biostat REDCap Help Queue
Monitored by 4 to 5 Administrators

60. REDCap Support

61. REDCap Goals Questions? Easy to use Metadata Driven Adaptable Features
Data entry validation
Self service tool
Questions?