1. REDCap Version 5.6.X By J Kevan Essmyer Acknowledgements:
Paul Harris (Vanderbilt CTSA)
Jack Baty (WUSM REDCap Admin)

2. Case Report Form / Activity Panel
Left Panel User
Control Menus
Case Report Form / Activity Panel

3. 647 Consortium Partners

4. 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

5. 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

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
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

7. Biostatistics Secure Domain
Public HTTPS Survey Access
Biostatistics Secure Domain
File Server
Uploaded Files
MySQL Server
Data
Data Entry / Admin / Surveys
WEB Server
Sync
MySQL Slave Server
Installation Files
Host Server

8. 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

9. 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.

10. 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

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

12. Data Export Tools
Use Cases: Export data with pre-built import syntax file

13. 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

14. Cross-sectional and Longitudinal Project Data Models

15. Templates

16. Templates Several default templates will be available immediately.
Projects can be modified once created.

17. Record Status Dashboard

18. Record Status Dashboard

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

20. Multiple Surveys Projects
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

21. Automated Survey Invitation Conditions

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

23. Reports

24. Data Visualization / Cleaning

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

26. Online Form Designer

27. Data Dictionary Spreadsheet
Combine/edit project forms
Share forms with other investigators
Access same metadata and functionality as the online designer tool

28. Field Types

29. Textbox Data Validation

30. Branching Logic Creation Tool

31. 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.

32. 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

33. User Permissions “Rights”

34. User Roles
Define custom roles for different user types (Data entry, PI, Monitor…)

35. 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

36. 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)

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

38. DDE Merge Tool

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

40. Data Quality Module (Data Queries)

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

42. 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

43. Treatment Randomization Module

44. Creating a REDCap project
Getting StaRTed

45. 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."

46. Getting Started Submit Request forms Create Project Create 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.

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. 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.

50. 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

52. 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 Help Queue
Monitored by 4 to 5 Administrators

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

54. Built-in User derived FAQ Resource

55. REDCap Support

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

57. 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)  (

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

61. 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

62. 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

63. Results

64. Data Quality Module (data queries)

65. Expanded API Functionality

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

67. 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

68. User Permissions “Rights”

69. 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.

70. File-Based Project Creation

71. 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

72. Forms Ready for Data

73. REDCap CRF

74. 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)

75. Creating a REDCap project
Getting StaRTed

76. 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)) )

77. 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