1. Managing Clinical Data Using REDCap
Peter E. Gabriel, MD
Andrew J Cucchiara, PhD
October 11, 2012

2. The Research Database Problem
The 27-version Excel spreadsheet…
The Access database created by the summer intern…
Paper surveys…
Hard drive crashes…
The statistician’s blues…
Sharing data outside Penn…
Security? Privacy? Audit trails? Oh my!

3. The REDCap Solution Research Electronic Data Capture
Web-based, user-friendly database system, originally developed at Vanderbilt University
Now overseen by the REDCap Consortium: 473 institutional partners in 48 countries
Supports concurrent access by multiple users from anywhere via web browser
Robust data integrity, nightly backups, etc.
Excellent security and privacy features, with extensive audit logging
HIPAA-compliant, 21 CFR Part 11 capable
Easy to export data to Excel and statistical packages
Supports surveys, ad-hoc reporting, event scheduling, file sharing, auto- data validation, branching logic, calculated fields, and more

4. REDCap Boot Camp
4/22/2017
Accessing REDCap
UPHS: CHOP:

5. Agenda Creating and Managing Projects Building Data Collection Forms
Entering Data
Controlling User Access Rights
Ad Hoc Reports and Exporting Data
(Advanced Tools)

6. Creating a New Project Enter Project Title: REDCap Boot Camp 4/22/2017

7. Select a Project Purpose
REDCap Boot Camp
Select a Project Purpose
4/22/2017
Only used to track usage statistics – does not affect functionality

8. Select a Project Type & Collection Format
REDCap Boot Camp
Select a Project Type & Collection Format
4/22/2017
Key Question:
Is REDCap right for your project?

9. REDCap Project Types Single Survey Data Entry Forms
Ideal for collecting anonymous, one-time responses from participants – similar to a basic SurveyMonkey survey
Participants are ed a link that points to a web form in order to collect responses; they do not need to have a REDCap account
Data Entry Forms
Intended for data capture by clinicians with a REDCap account
Single Survey + Data Entry Forms
Can be used to initially populate records with participant responses in order to initiate data collection (example: pre-screening survey)

10. Data Entry Collection Format
REDCap Boot Camp
Data Entry Collection Format
4/22/2017
Classic Data Collection
Data to be collected once per subject – i.e. one “record” per subject
Longitudinal/Repeating Collection
Data collected multiple times per subject
Fixed number of collection points that correspond to pre-defined events, e.g. Initial Evaluation, 3mo. follow-up, 6mo. follow-up, 1yr follow-up
Optional scheduling via project calendar

11. A Brief Word on Data Relationships
REDCap Boot Camp
A Brief Word on Data Relationships
4/22/2017
One-to-many and many-to-many relationships are common in healthcare data
E.g. one patient can have many diagnoses, procedures, medications, lab results, etc.
Data sets containing these complex relationships may need to be restructured in order to work with REDCap
Example:
This will not work in REDCap as structured.
Study ID
Dx Code
Medications
Hgb A1c
Hgb A1c Date 1
250.00
Metformin
5.2
11/2/2005
Sulfonylurea
6.4
3/1/2010
7.6
7/5/2012
7.2
10/3/2012 2
250.02
Insulin
8.0
10/24/2011
8.2
4/13/2012

12. Options for Restructuring Data
Convert multi-valued data fields into a series of “yes/no” fields
Example: Aspirin Yes/No? Beta blocker Yes/No?
Summarize your longitudinal data points into aggregate statistics over a fixed time period and use “Classic” collection format
Example: Min Hgb A1c, Max Hgb A1c, etc.
Align your longitudinal data points with pre-defined events and use “Longitudinal” collection format
Example: Pre-Treatment PSA, 6-month post-treatment PSA

13. Restructuring Data - Examples
REDCap Boot Camp
Restructuring Data - Examples
4/22/2017
Complex data with many-to-many relationships…
Study ID
Dx Code
Medications
Hgb A1c
Hgb A1c Date 1
250.00
Metformin
5.2
11/2/2005
Sulfonylurea
6.4
3/1/2010
7.6
7/5/2012
7.2
10/3/2012 2
250.02
Insulin
8.0
10/24/2011
8.2
4/13/2012
…restructured to be “flat:”
Study ID
Dx Code
Insulin
Metformin
Sulfonylurea
Max Hgb A1c
Max Hgb A1c Date 1
250.00 No
Yes
7.6
7/5/2012 2
250.02
8.2
4/13/2012 3
8.7
6/2/2012 4
250.42
9.6
8/16/2012

14. Restructuring Data - Examples
REDCap Boot Camp
Restructuring Data - Examples
4/22/2017
Complex data with many-to-many relationships…
Study ID
Dx Code
Medications
Hgb A1c
Hgb A1c Date 1
250.00
Metformin
5.2
11/2/2005
Sulfonylurea
6.4
3/1/2010
7.6
7/5/2012
7.2
10/3/2012 2
250.02
Insulin
8.0
10/24/2011
8.2
4/13/2012
…restructured to be “event-based:”
Study ID
Event
Dx Code
Insulin
Metformin
Sulfonylurea
Hgb A1c 3
Initial Eval
250.00 No
Yes
8.6
3 Mo. F/U
8.4
6 Mo. F/U
8.0
1 Yr F/U
7.4

15. Creating a New Project Enter Project Title: REDCap Boot Camp 4/22/2017

16. Navigation Pane Center Work Area
Project Setup
Navigation
Pane
Center
Work
Area

17. Project Setup
These buttons are only a “to-do list” for your benefit – they do not control project functionality

18. Project Setup
We just did this when we created the project – click here if you need to go back and change the format again

19. Project Setup
Advanced settings – more on these later

20. Project Setup
Copying, archiving, and deleting a project

21. Project Setup
Best way to get started building forms

22. Data Collection Instruments
REDCap Boot Camp
Data Collection Instruments
4/22/2017
An instrument is a single data entry form
A subject has exactly one record across all data entry forms – i.e. all the data fields eventually combine into one big row per subject in the exported data

23. Data Collection Instruments (cont.)
REDCap Boot Camp
Data Collection Instruments (cont.)
4/22/2017
So why have more than one instrument?
Logical grouping of related data fields
Can control user access at the instrument level – e.g. a data entry assistant can be restricted from seeing the demographics form that contains PHI

24. REDCap Boot Camp
REDCap Shared Library
4/22/2017
The REDCap Shared Library can be a good source for standardized instruments, e.g. CDASH, SF-36, FACT-G, etc.
Content will hopefully grow over time

25. Data Collection Instruments
REDCap Boot Camp
Data Collection Instruments
4/22/2017
Click instrument name link to:
Modify an existing form
Add additional fields to form
Modify existing questions
Change attributes of questions

26. Online Designer Data Fields Add New Field Section Header
REDCap Boot Camp
Online Designer
4/22/2017
Data Fields
Add New Field
Section Header
Preview Button

27. Data Field Operations REDCap Boot Camp 4/22/2017

28. A Note on the Study ID Field
The first data field in every project is the unique record identifier for that project
Default variable name is “study_id” but you can rename it to something else
Can be a “real” ID like MRN or SSN, or a randomly-assigned number. Must be unique.
Can set it to be auto-assigned by REDCap
(Project Setup  Make customizations  Use auto-numbering for naming new project records)

29. Creating / Editing a Data Field
REDCap Boot Camp
Creating / Editing a Data Field
4/22/2017

30. REDCap Boot Camp
Field Types
4/22/2017

31. Defining the Field Attributes
REDCap Boot Camp
Defining the Field Attributes
4/22/2017
Variable Name
Unique data column name
Validation
Data type/format constraints
Required
Mandatory field
Identifier
Mark as an identifier (PHI)
Custom Alignment
Question arrangement
Field Note
Additional instruction for data entry person

32. Variable Name Requirements
REDCap Boot Camp
Variable Name Requirements
4/22/2017
Should be descriptive (i.e. not cryptic as with a1, xyz, lol). The variable name is how analysis data is referenced.
The first character of a variable name must be an alphabetical character (i.e., A to Z or a to z).
All other characters of a variable name may contain alphabetical characters, numbers 0 to 9 or underscores (i.e., spaces, punctuation marks, mathematical functions, special characters and symbols are NOT allowed).
Length of variable names should contain fewer than 26 characters; shorter variable lengths are better to reduce the risk of truncation by statistical analysis packages.
Variable names must be unique among all instruments (i.e. forms) within a specific REDCap Project.

33. REDCap Boot Camp
Text Field Validation
4/22/2017
Verifies data input to prevent invalid entry, prior to form submission

34. Required Fields Required fields are labeled with *must provide value
REDCap Boot Camp
Required Fields
4/22/2017
Required fields are labeled with *must provide value
Warning prompt when trying to save:
Not a “hard stop” - possible to override

35. REDCap Boot Camp
“Identifier” Fields
4/22/2017
Fields that constitute protected health information (PHI) can be marked as an “Identifier.”
These fields can then be excluded on data export, allowing for analysis of “de-identified” data
Users can also be restricted in their ability to export Identifier fields based on access rights

36. Custom Alignment Examples
REDCap Boot Camp
Custom Alignment Examples
4/22/2017
Custom Alignment controls the position and orientation of the responses on data entry forms.

37. Permissible Values for Multiple Choice Fields
REDCap Boot Camp
Permissible Values for Multiple Choice Fields
4/22/2017
A value (1 to n) is automatically assigned to each choice when the field is saved:
Can also manually code values yourself by entering ‘# , text description’

38. Creating a Conditional Field
REDCap Boot Camp
Creating a Conditional Field
4/22/2017
Branching logic can be used to show fields that meet a certain condition

39. Creating a Conditional Field (cont.)
REDCap Boot Camp
Creating a Conditional Field (cont.)
4/22/2017
Specify the variable and value of the field that makes the condition true
Complex AND / OR / NOT logic is possible is possible with the “Advanced Branching Logic Syntax” (vs. the “Drag-N-Drop Logic Builder”)

40. Creating a Conditional Field (cont.)
REDCap Boot Camp
Creating a Conditional Field (cont.)
4/22/2017
The field containing branching logic will show/hide based on the value of the field(s) it depends on

41. Agenda Creating and Managing Projects Building Data Collection Forms
Entering Data
Controlling User Access Rights
Ad Hoc Reports and Exporting Data
(Advanced Tools)

42. Starting Data Collection
REDCap Boot Camp
Starting Data Collection
4/22/2017
The Data Collection area of the navigation pane, lists all the forms (aka instruments) available for the project
In order to create a new record, the form that contains the Study ID must be entered first.

43. REDCap Boot Camp
Creating a New Study ID
4/22/2017
A new record is created whenever a non-existing identifier is entered on the first page of the data collection interface.
If the record already exists then the record for that Study ID is retrieved.

44. Using an Existing Study ID
REDCap Boot Camp
Using an Existing Study ID
4/22/2017
An existing Study ID can also be selected from the appropriate dropdown list on the first page of the data collection interface.

45. Form Status
All collection forms (aka instruments) have a “Form Status” field at the end of the form
There are three possible record statuses:
Incomplete
Unverified
Complete
“Save Record” saves and exits the record
“Save and Continue” saves and opens the next collection form if there is one, or saves and keeps the current record open if not

46. Viewing the Edit History
To view the edit history for a particular field, click the “H” icon next to the field:

47. User Rights and Permissions
REDCap Boot Camp
User Rights and Permissions
4/22/2017
Allows you to grant a user full or partial access to the project

48. Granting User Privileges
REDCap Boot Camp
Granting User Privileges
4/22/2017
Basic user rights include access to various modules and ability to export PHI

49. Granting User Privileges
REDCap Boot Camp
Granting User Privileges
4/22/2017
Ability to lock a particular record from further editing
Ability to Create / Rename / Delete project records
Data Entry Rights are specified individually for each data collection form

50. REDCap Boot Camp
Data Access Groups
4/22/2017
Data Access Groups is an advanced feature useful for multi-center trials and collaborations
Users in a particular Data Access Group can only see records entered by other users in that Data Access Group

51. Ad-Hoc Reporting
“Report Builder” allows you to run simple queries within REDCap

52. Ad-Hoc Reporting (cont.)
“Graphical Data View & Stats” provides some simple statistics for every field in a particular data collection instrument

53. Data Export
Simple Data Export can be used to export an entire project data set
Advanced Data Export allows you to select specific fields and de-identify the data set if desired

54. Data Export – De-Identification Options

55. Data Export – Available Formats
Can export to comma-separated values (.csv) format and a variety of statistical package formats
For Excel export, “Raw” option includes variable names as column headers; “Labels” includes descriptive field names

56. Advanced Features Customizing project settings
Creating and managing forms and data fields using the downloadable “data dictionary”
Importing data
Data Quality module
File Repository
Event Log

57. Resources Beyond This Course
Andy Cucchiara )
Pete Gabriel )
Join CHOP/UPenn REDCap Users’ Group Meetings
Usually first Wednesday each month
Physically attend at 3535 Market St
Virtually attend via ‘GoToMeeting’
REDCap Help & FAQ, Training Resources: