Research Electronic Data CaptureData Management and Survey Tool

http://catalyst.harvard.edu

Lynn Simpson, MPHResearch Analytics & Data Service ManagerPartners HealthCare | Enterprise Research Infrastructure & Systems Harvard Catalyst | The Harvard Clinical and Translational Science Center

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Partners Research Information Services & Computing

Tools, apps, & servicesSecure infrastructure

Example Research Workflow:

rcc@partners.orgrc.partners.org

@phseris

Set-up Study/Lab

Feasibility/Design

Collect Data

Collaborate

ManageData

Analyze Data

RPDR Query Tool

REDCap

LimeSurvey

StudyTRAX

RPDR

Biobank

File Sharing

Mailing List System

Freezerworks

Computational Resources

Research Computing

Core Facility

File Storage

Archival Storage

Purchasing

Website & Server Hosting

Desktop & Mobile Services

Remote Access

Team Collaboration

Databases & Data Services

Desktop Backup

Bioinformatics Data Processing

Medical Image Processing

Statistics, Analysis & Visualization

Big Data Analytics & Machine Learning

Biobank Portal

FREE license from Vanderbilt U. Medical CenterREDCap Consortium = 2309 Institutions, 108 Countries

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http://project-redcap.org/

Overview

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Free,Licensed from Vanderbilt U. Medical Center

Secure,Hosted by PHS IS Research Computingo No purchasing, downloading software, or storing data locally

Web-based applicationo PC and Mac compatible o Mobile device, Smart-phone friendlyo Accessible via internet (no VPN, remote access required)o Compatible with all popular web browsers

Safari, Internet Explorer, Chrome, Firefox…

Fully customizable - You are in total control of shaping your database or survey. Define:

§ Question / Field types§ Validation for text fields (dates, numbers, ranges) § Calculations§ Branching logic: hide/display fields based on data entered§ Piping: display data entered across forms / visits

§ No limit to number of data fields or forms you can program

Mid-study modifications - Modify projects as needed during the course of your study.

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Overview

Support Model

1.5 FTE : 10,016 Projects : 11,633 Active Users1-2 Business Days for most responses2-5 Business Days for some requestsedcsupport@partners.org

Self Service Module:• Help & FAQ • Getting Started website: http://rc.partners.org/redcapgettingstarted• Knowledgebase: Guidelines, How-To Articles, Feature Highlights.

Test site: http://redcap-training.dipr.partners.org/redcap/This is open access to internal Partners users - do not enter real

research or clinical study data.

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Online Form Editor

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Q: How much experience with programming, networking and/or database construction is required to use and design EDC tools in REDCap?

A: No programming, networking or database experience required.

Use Point-and-Click interface to design your EDC tool(s).

Database Design: Data Dictionary

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Or use “Off-line” Excel .csv File to build forms

Project Home > Other Functionality

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Benefits: Shared Library

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REDCap Library:

Accepting requests for open domain assessments

REDLOC:- Builds Forms - Obtains Licensing

Requirements

Project Settings

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There are two data collection instrument types:

1. Data Entry Forms: Data entry by study team2. Survey: Data entry performed by subjects, participants

Data Collection

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(1) Data Entry by Project User

REDCap Account

Required

https://redcap.partners.org/redcap

Survey

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(2) Data Entry by participants subjects

SURVEY

No log in required.

REDCap generates unique URLs

https://redcap.partners.org/redcap/surveys/?s=GrQES4YYR8

Project Settings

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There are two data collection instrument types:

1. Data Entry Forms: Data entry by study team2. Survey: Data entry performed by subjects, participants

There are two data collection formats:

1. Classic: One record per patient (WIDE)2. Longitudinal: One record per patient per event, with

the possibility of defining multiple arms (LONG)

Wide vs Long Design

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Traditional VS Longitudinal

Wide vs Long Design

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•Each FORM will create fields in database- Data model by REDCap is EAV – Single Table

•Projects with multiple visits executed two ways

(1) Traditional Format: (WIDE)- Create unique forms for each Visit- Data saved as one row with distinct fields

Traditional Design

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Wide (multivariate) Example

§ Each record is a row in data export§ Each Lab Visit variable is unique:

alb_b, alb_v1, alb_v2, alb_v3…

Limitations: Ø To search for all Albumin > 10,

must parse through all alb_ variables

Ø List of forms may get unruly if you have a lot of forms / visits; Useful for trials with less time points

Wide vs Long Design

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(2) Longitudinal Format (LONG)

- Create 1 Form for each measure- Create Events for each visit- Designate FORM to multiple EVENTS- Data saved as multiple rows with same field

• As # of EVENTS increase this option easier to execute

Longitudinal Design

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Raw Data Representation

AnewrecordiscreatedforeacheventALLdatacollectedforasingleeventappearsinonerecord

Un-utilizedEventsdonotgeneraterecords

Greendotdenotesthatdatahasbeenenteredforevent

Wide vs Long Design

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Traditional VS Longitudinal

Repeating Instruments/Events

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Ability to repeat a data collection instrument or an entire event of instruments an unlimited number of times without having to specify the amount needed

Reports & Data Exports with Repeating Instruments/Events

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'redcap_repeat_instance' - the instance number, which is an auto-numbered value (starting with '1') that gets incremented each time the instrument/event is repeated.

'redcap_repeat_instrument‘ – includes form_name for repeating instrument• Included automatically in the report or data export• Displayed as a new row in the report or export file.

Data Management Applications

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Calendar - View and edit project calendar for scheduling and event tracking

Data Exports, Reports, and Stats - Extract data fields from database to Microsoft Excel, SPSS, SAS, R, STATA software (Ability to de-identified data sets), View Plots (graphical representations) and Descriptive Statistics for data entry forms; view, edit, copy, delete custom reports; query database in real time and display data in a table format.

Data Import Tool - Add and edit data by importing data into database from a Microsoft Excel file

Data Comparison Tool - Compare database records entered by designated data entry persons (double data entry)

Logging - View and export a list of all changes made to the database, including data exports, data changes, and the creation or deletion of users

File Repository - View, upload, and download project files; view and download previous data exports (data and syntax stored files)

Data Access Groups (DAGs) - Restrict access to database records by group, users in the same Data Access Group can access records created by that group.

Record Locking / Locking Mgmt – Lock records to disable changes

API – Allows external applications to connect to REDCap remotely; automate imports and exports

REDCap Mobile App – Collect data offline (no internet access) to sync back to project

User Rights

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Customize Each User:Application RightsData Entry Rights

Export

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REDCap Data Export

• Export to Excel, SPSS, SAS, STATA, R

• Numerous de-identification options

- Removal of fields that contain PHI

- Automatic removal of date fields; date shifting

• Exports include corresponding syntax files

• Maintain record of entire export history

Reports

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Graphical Views & Stats

Data Quality

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Add / Edit Records

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Surveys

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- Public URL vs Participant List vs Designate an Email Address

- Anonymous

- Multiple Surveys linked to specific Participant

- Automated Survey Invitations

Survey Settings

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- Survey Title- Survey Instructions- Logo- Size of survey text- Font of survey text- Survey (color) theme- Question Numbering- Question Display Format- Require Field options- Survey Expiration Date- Save & Return option- End of Survey Options:

• Auto-Continue to next survey

• Redirect to a URL• Survey completion text

Survey Settings

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Longitudinal Example

Advantages- Can designated certain instruments at certain events- Can track which surveys have been completed

Limitations- “Save&Return” option may not be as intuitive to manage because each survey has it’s own link; Participant only receives 1st survey link.

Public URL vs Participant List vs Designated Email

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Public Survey URL: • Single survey link for your project which all participants • Link can be copy and pasted into:

• The body of an email message in your own email client• Posted to web pages.

• Limitations: allows for the possibility of participants taking the survey multiple times.

• Advantages: Participants can forward or resend the link to other participants.

Participant List: • Send emails and track who responds to your survey• Identify an individual's survey answers by providing an Identifier for

each participant. • Limitations: Must know email addresses• Advantages: Tracks Responders / Non-Responders

Public URL vs Participant List vs Designated Email

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Designate an email field :• Example field designated: email ("E-mail address"): • Capture email addresses for sending survey invitations on a form/

survey• Any records with entered email address will have that email address

show in the Participant List• Limitations: Email address saved to record• Advantages: First instrument does not have to be a survey

Anonymous Surveys

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Truly Anonymous = Public Survey Link

“Honest Broker” = Coded Participant List• “Behind the scenes” link • Information is provided to investigators in such a manner that it would not

be reasonably possible for the investigator or others to identify the corresponding patients-subjects directly or indirectly.

• REDCap/REDCap Admins have access to the key to the code.

Public Survey Link or the Participant List• For either method, the survey questionnaire must not contain any

questions asking the participants for identifying data • What is your email? name? address?

Participant Contact List• Do not enter unique values into the "Participant Identifier” field

• Links the email address to the survey responses.

Automated Survey Invitations

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Getting Started

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Partners HealthCare Access: https://redcap.partners.org/redcap/Partners users can log in with their Partners usernames and passwordsExternal users: contact EDC Support edcsupport@partners.org

Language for grant and IRB submission:http://rc.partners.org/boilerplates

Getting Started website: http://rc.partners.org/redcapgettingstarted

Training:There is no formal training required to use REDCap. Video tutorials and Help&FAQ page in REDCap contain a lot of useful information.

Test site: http://redcap-training.dipr.partners.org/redcap/This is open access to internal Partners users - do not enter real research or

clinical study data.

Contacts

Contact Information for Harvard Catalyst REDCap Support Staff

Lynn Simpson, MPHJeremy AlphonseMGH, BWH, Spaulding & McLeanedcsupport@partners.orghttp://rc.partners.org/edcredcap

BIDMC, Children’s & Joslinedc@bidmc.harvard.eduhttp://www.bidmc.org/Research/CoreFacilities/REDCapEDC.aspx

For support for other Harvard schools or affiliated academic health care centers,contact edcsupport@partners.org

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