REDCap A Tool for Data Collection and Management ITHS Biomedical Informatics Core iths_redcap_admin@uw.edu

1

Last updated December 13, 2012

REDCap version: 4.9.7

Goals & Agenda

Goals • Overview • Getting Started

Agenda • Introduction • Practical issues • Getting access to REDCap • Basic project workflow • Interactive Q&A

2

What is REDCap?

REDCap = Research Electronic Data Capture

• Web-based • Cross platform • Secure • Built for research • High customizability

3

Background Statistics

• Created by Vanderbilt University in 2004

• Supported by a consortium of 511 institutions using REDCap in 49 countries:

• over 53,300 projects in production

• over 70,400 end-users

• At UW/ITHS since 2009:

• over 500 projects (over 213 in production)

• over 900 active users

4

Why Use REDCap? • Collection of data

• Accessibility • Secure • Easy of Use • (Quality) Control • Flexibility • Autonomy

• Wide user base • Support • Training materials • Institutional knowledge

5

REDCap & Security

• Software Set Up • Managed by the UW • Encryption (256 bit) & Secure servers • UW HIPAA protocols

• 3-Tiered Access • System Login • Project Access • User Restrictions

• Audit Trails • Logging feature

• De-identified Data • Can identify variables as PHI • Export module with de-identifying option

6

Costs: Overview No Charge

• Funded by NIH until 2017 to provide REDCap at no charge

• Basic level of support - Introductory classes - Advanced classes - Supplementary online

documentation - Drop in sessions (TBA) - Up to 1 hour consultation

for new projects

Charges • Project development

• EMR data import/export

• Recovering data deleted by user error

• High rate of post-production changes

7

Note: ITHS reserves the right to change these terms as needed to preserve, extend, and sustain the REDCap resource.

Responsibilities: Overview STUDY TEAMS • Request project creation • Project setup and design • Add users and manage user rights • Regulatory approval to use REDCap • Request to move project to production • Inform ITHS when project completed • Staff training for data entry • Terms of use for published and validated

forms – paid and contracted for appropriately

• Charges for associated ITHS fees • Data management policies and

procedures • Attend ITHS training and learn to be self-

sufficient in resolving problems using available resources, including REDCap community

ITHS • Host secure, reliable REDCap software • Periodically upgrade REDCap software • Train end users • Enable advanced features, such as

project linking, and double data entry • Approve new project creation • Review project changes to prevent data

loss and ensure data integrity • Provide limited technical support for

difficult problems not resolved by users or REDCap community

8

Logging into REDCap

• Go to https://redcap.iths.org • Select one of the following credentials

• UW net ID • Protect Network • Stanford University • Medical University of South Carolina • University of Alaska Statewide System • University of Chicago

• More info can be found at : REDCap Documentation

9

General Orientation •Home •My Projects •Request new projects •Training Resources •Help & FAQ •Send It

Time-out: After 30 minutes of inactivity

10

• Practice / Just for fun • Operational Support • Research

• Include PI name and contact information • Include IRB number

• Quality Improvement • Other

Request Project - Purpose

11

Request Project - Type STEP 1: PROJECT TYPES • Single Survey • Data Entry Forms • Single Survey + Data Entry Forms

STEP 2: COLLECTION FORMAT • Classic • Longitudinal

12

Approval Process • Security • Smooth Operations • Double Check • Data Loss Prevention

• Done by a local REDCap Administrator • Within 1 business day

13

Project Setup

14

Project Set-Up Step by Step Process

• Project Settings • Instrument Design • Bookmarks (Optional) • User Rights (Optional) • Move to Production

Production Status • Draft Mode • Approval Requirements

15

Project Settings Project Settings • Editing of the initial settings Project Customization • Auto-numbering • Order the records by another field • Set a custom record label • Data history widget • Display the Today/Now button • Require a ‘reason’ for editing existing records

16

Design your Forms ONLINE DESIGNER

• Point & Click • Best suited < 30 variables

DATA DICTIONARY • Spreadsheet • Best suited > 30 variables

REDCAP LIBRARY • Import directly into your project • PI responsible for “terms of service”

17

Field Types

•Text Box •Radio Buttons •Drop-down List •Checkboxes •Notes Box •File Upload •Slider / Visual analog scale •Yes – No •True – False •Calculated Fields

Text Box --------

Checkboxes ---------

Drop-down List--------

Radio Buttons ------

Notes Box -------

Example Case Report Form

18

Creating Fields

•Field Type •Field Label •Variable Name •Validation? •Required? •Identifier? •Custom Alignment •Field Note

19

Example Text Box Type

Branching Logic

• Hiding/Showing Fields

• Logic based

• Project Limited

• Drag & Drop

• Syntax based

• FAQ for syntax

20

Branching logic builder

Data Dictionary

• Excel: Comma Separated Value (CSV)

• Meta-Data

• Defines entire project

• Double check on import

• Back-up your project beforehand

• Use syntax found in FAQ

21

User Rights

User Rights • Powerful Tool • Fine-Tune Rights

Data Access Groups • Double Data Entry • Multiple Sites

22

Example of User Rights options

Pre-Production Checklist

Project Setup Tab • Design data collection

instruments

• Design Instruments

• Test Instruments

• Assign user rights (& DAG’s)

• Move project to production status

23

Example of a Project Checklist

Moving a Project into Production • Run “Check for Identifiers”

• 18 identifiers considered PHI & comply with HIPAA

• Test Content can be deleted (controlled by checkbox)

Practical Notes:

• Have IRB approval.

• Be ready to screen, enroll or survey participants.

24

Request “Move to Production” Pop-up

Make Changes in Production

Change Steps • Enter Draft Mode • Select form you want to modify • Make changes • Review changes • Submit Change for Approval

Potential for Data Loss • Change variable/form name or delete

variable/form • Change Choices in dropdowns,

checkboxes, or radio buttons • Change Field Type from text to radio

buttons or dropdowns • Remove an event or a form from an event • Modify project settings

All changes reviewed by REDCap Admins

25

Example of Draft mode in production status

New Features in Version 5

26

• New optional project modification settings • Data Import: Import multiple events • Randomization functionality • Publication matching module • Matrix field types • Multiple surveys per project • New invitation functionality

Learn How To Use REDCap INTRODUCTION TO REDCAP • WHEN: (once a month, days/times to be determined) • WHERE: South Lake Union

ADVANCED CLASSES • WHEN: (to be determined in 2013) • WHERE: (to be determined in 2013)

ONLINE VIDEOS & HELP • REDCap Training Resources • FAQ • Supplemental Documentation

ONGOING HELP • EMAIL: iths_redcap@uw.edu

(REDCap community email list) • EMAIL: iths_redcap_admin@uw.edu

(REDCap administrators; last resort for help)

27

Future Advanced Classes

• Data Dictionary - Importing and Exporting Data

• User Rights - Data Quality - Logging - Double Data Entry

• Longitudinal Studies

• Surveys - Linking Projects

Schedule and Locations will be on the ITHS website & will be announced in email to users.

28

Appendix

29

• Project Basics • Data Collection Tips • Identifiers • User Management - Best Practices • Workflow Testing • Data Entry Tips

Appendix: Project Basics Status • Development: Create project/forms/fields; TEST data entry forms! • Production: Collect data; export for analysis

Users • Person submitting “Request New Project” added as user Note that REDCap does not recognize this first user as a “project owner”

(Adding additional users will be covered later.)

Study ID All records* have a unique ID, which is always the 1st field on the 1st form! • Survey / Survey + Data Entry: automatically generated on backend • Data Entry: enter manually or automate

*A REDCap “record” consists of ALL data (i.e., all forms) for a participant - contrast with Access relational database IMPORTANT: If you change the order in which your forms appear on the Data Collection menu, you’ll have to make sure the form containing your Study ID field is kept at the top.

Data Collection • Survey: one form - the survey • Data Entry: Demographics is the default form provided by REDCap at project creation • Survey + Data Entry: Pre-screening survey + data entry form(s) • Form Order: Specified in Online Designer

30

Appendix: Data Collection Tips Collect Clean Data that can be Analyzed • What data are you expecting to collect? • How can you reduce errors? • How can you promote consistency?

Best Practices • Validate: Emails, phone numbers, dates, integers, numbers, set min & max ranges • Unknown dates: Use date picker or capture day, month and year separately • Discrete data: Separate things like street, city, state, zip; collect age (not “> 30”) • 2-part numerical values: Capture separately, i.e. gestational age, 36 weeks, 2 days • Directions & notes: Help participant or data entry person input the data you want • Multi page surveys: Indicate progress to participant, such as page 1 of 5 • Create log forms to track events that span multiple days or multiple visits instead of

adding fields to track adverse events or concomitant meds to each visit form (longitudinal studies)

31

Appendix: Check Identifiers

• Name (including initials) • Geographic subdivision (<

state) • All elements of dates (except

year) • Age > 90 years old • Phone or Fax • SSN • Email addresses • MRN • Health insurance # • Account #

• Certificate/ license # • Vehicle identifiers • Device identifiers • URLs • IP address #’s • Biometric identifiers • Photographs or comparable

images • Any other unique identifying #

(e.g. last 4 digits of SSN)

To de-identify data, what types of data need to be obfuscated?

32

Appendix: User Best Practices

33

• Users are assigned per project • User management

• Pick 1 or 2 people to manage users and assign rights. The PI should be a user!

• Who to add • The study PI is responsible for ensuring that all users are listed on the IRB

submission(s) • How to add users to your study*

• UW users: Use UW NetID ([UW NetID]@washington.edu)

• Non-UW (ITHS affiliates): Use ProtectNetwork ID ([ProtectNetwork ID]@idp.protectnetwork.org)

• User Rights (aka “permissions”) : Links in Project Setup, Project Home tabs & navigation menu

• Data Access Groups: Multi-site data entry or Double Data Entry Users who don’t belong to any group are in all groups by default

*For complete information on how to add users, see https://redcap.iths.org/redcap/redcap_v4.9.7/iths/REDCapAuthentication.pdf

Appendix: Testing Workflow

• Import data from .csv file • Download template, add data, and upload • Upload event by event for longitudinal studies

• Export test data In raw form & for statistical packages

• Add users • Build reports • Create data quality rules • Test renaming and deleting records • Change management plan

Once the project is in Production status, all changes must be reviewed by a REDCap administrator. Also, if new events are added, an administrator has to define them and assign instruments.

34

Appendix: Data Entry Tips • Manual Data Entry

Enter a study ID and press the Tab key • Auto-Number

- Starts with 1 - Can override this by creating a dummy

record with a number other than 1 • Timeout

REDCap times out after 30 minutes of inactivity. Make sure to click save button.

• Save Options - Save - Save and Continue - Save and Next Form

• Form Status (circles vs. form names!) - Incomplete = red - Unverified = yellow - Complete = green

Miscellaneous: • History Icon

History of data changes for a field • Edit Instruments Link

When in Development, can make changes to forms

• Print out case report forms (download PDF) For review by team and statistician

• Test Data Deleted When project moved to Production

35