Introduction toSponsored by the Pediatric Research Office (PRO)

Agenda

•Overview of REDCap•Basic project work flow•Creating a project with REDCap•Interactive demonstration•Questions and Answers

Overview of REDCap

• A secure web application for building and managing online surveys and databases, originally developed at Vanderbilt University in 2004

• Now overseen by the REDCap Consortium: 2,042 institutional partners in 107 countries

• Supports concurrent access by multiple users from anywhere via web browser

• REDCap can be installed in a variety of environments for compliance with such standards as HIPAA, 21 CFR Part 11, FISMA (low, moderate, high), and international standards. Because *you* have direct and total control over your system, REDCap is fully personalized to meet your security policies and user needs.

Why Use REDCap?

• Supports surveys, ad-hoc reporting, event scheduling, file sharing, auto- data validation, branching logic, calculated fields, and more

• Easy to export data to SAS, SPSS, Stata, R, Excel, or pdf.

• Input data from anywhere in the world with secure web authentication, data logging, and Secure Sockets Layer (SSL) encryption.

• Projects can be used by researchers from multiple sites and institutions

Why Use REDCap?

• Validation and skip logic features

• You can modify the database or survey at any time during the course of your study

• Data may be imported from external data sources

• Double data entry / blinded data entry

• Save forms as PDFs to collect responses offline

Costs:

No Charge:• The PRO provides REDCap free of charge for faculty, staff, and

external collaborators of the UAB Department of Pediatrics• Basic level of support:

• Introductory class• Advanced class (possible in the future)• Basic consultation for new projects to discuss data management plan

etc.

Costs:

Charge:• Project development• Data Management of the project

Security:

Managed by the Department of Pediatrics IT3-Tiered Access

• System Login• Project Access• User Restrictions

Audit Trails• Logging feature

De-identified Data• Identify variables as PHI• Export de-identified data

User Responsibilities:

• Request general access to REDCap by completing the REDCap Account Access Request Form for each individual who will need access to the database (project) being developed.

• Project setup and design• Getting project to production• Users rights management• IRB approval to use REDCap for data collection / management• Inform PRO – Data Management when project is complete• Terms of use for published and validated forms

PRO Responsibilities:

• Approve and establish new user accounts

• Periodically request REDCap upgrade of PEDS IT

• Provide basic training to end users

REDCap FLOW

Creating a project with REDCap

First, decide on the data that you need to collect that will answer your research question!

Basic Data Management Tips:

• Whatever software you want to use to collect your data consider what information you want to collect.

• Some information will be for following participants and study activities such as contact phone numbers, email, expected study visits, etc.

• This information likely does not need to be in your permanent research study data base.

Basic Data Management Tips:

• Research Study data • Study ID, DOB, Race, Demographic information and other research questions

and information• Data that will help answer your research question

• Develop your source documents before deciding on the layout of the data base

• There will be multiple forms in your data base for your project• Form = Visit• Form = Medical Record Abstract

Project Creation in REDCap

• Name of the project / study• What the project is for

• Just for fun / practice• Research

• Include PI name and contact information• Include IRB number etc.

• Operational Support• Quality Improvement

Longitudinal Studies:

• Modeled after Clinical Trial Studies• Use for studies with multiple study visits• Allows for:

• Multiple arms example: Case / Control• Multiple events• Multiple forms - can assign one form for multiple visits

Survey Studies:

• Public Instrument link provided for distribution• Aids in sending out the link, sending reminders and tracking responses• Respondents go to the secure webpage and submit their data

• No login needed• Just need internet access

• Some field types have additional functions in a survey• Example: Section headers – In surveys, they are used to indicate a page break or

separate screen for the respondent to page through.

Empty Project:

• Setting up the data forms from scratch, not using templates

• Can create multiple forms for a project

• Step by step process similar to the set up of longitudinal studies and surveys

Project Set-Up in REDCap

Step by Step Process• Main Project Settings• Instrument Design• Event Design (for longitudinal study design only)• Modules (Optional)• Bookmarks (Optional)• User Rights (Optional)• Move to Production

REDCap Mobile App:

• Each project requires an API Token• The REDCap API is an interface that allows external applications to connect to

REDCap remotely, and is used for programmatically retrieving or modifying data or settings within REDCap, such as performing automated data imports/exports from a specified REDCap project.

Design your Data Collection Instruments:

1 2 3

Online Designer:

• Create new fields for each piece of data • Determine:

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

Field Types:• Text Box• Radio Buttons• Drop-down List• Checkboxes• Notes Box• File upload• Slider• Yes-No• True-False• Calculated Fields• Dynamic SQL

Data Dictionary

• Your project structure in spreadsheet format• Excel: Comma Separated Value (CSV) file• Can make changes in the dictionary and then upload

them to REDCap• Can create a new data entry instrument from a data

dictionary if you follow the specific syntax required by REDCap.

• Faster to use if you have lots of data entry fields

Pre-Production:

•Project Setup Tab• Design data collection instruments• Test Instruments• Assign User Rights• Move project to production status

Moving a Project into Production:

• Check for Identifiers • Mark fields that are considered PHI so they can be

excluded easily when running reports or exporting data• Test Content can be deleted• Have IRB approval

• Can be developing the data instruments while waiting for IRB approval

• Be ready to screen, enroll or survey participants• Easier to make changes to the data instruments before it

goes into production

Making Changes in Production

• Potential for Data Loss• Changing variable or form name or deleting variable or

form• Changing choices in dropdowns, checkboxes, or radio

buttons• Changing field type from text to radio buttons or

dropdowns• Removing an event or a form from an event• Modifying project settings

My First Practice Instrument

Log into REDCap using the following link:

https://redcap.peds.uab.edu/redcap/redcap_v6.11.4/ControlCenter/view_users.php

Variable / Field Name Form Name Section Header Field Type Field Label Choices, Calculations, OR Slider Labels Validations

StudyID Screening Demographics text Study ID Low=11001 High=11500

VisitDate Screening Demographics text Visit Date Date(M-D-Y)

DOB Screening Demographics Demographics text Date of Birth Date(M-D-Y)

Mage Screening Demographics calculated Mother's Age datediff([dob],[visitdate],"y","mdy")

Ethnicity Screening Demographics radio (single answer)

Ethnicity

Race Screening Demographics checkbox (multiple answers)

Race

Insurance Screening Demographics dropdown (single answer)

Insurance

Specimenscollected Screening Demographics Specimens Collected

yesno Were specimens collected at this visit?

Specimens Screening Demographics checkbox (multiple answers)

Specimens collected Branching Logic: [specimenscollected]='1'

SalivaCollectDate Screening Demographics text Saliva Collect Date Branching Logic: [specimenscollected]='1' and [specimens(1)]='1'

Date(M-D-Y)

DBSCollectDate Screening Demographics text DBS Collect Date Branching Logic: [specimenscollected]='1' and [specimens(2)]='1'

Date(M-D-Y)

Variable / Field Name Form Name Section Header Field Type Field Label Choices, Calculations, OR Slider Labels ValidationsStudyID Screening Demographics text Study ID Low=11001 High=11500VisitDate Screening Demographics text Visit Date Date(M-D-Y)DOB Screening Demographics Demographics text Date of Birth Date(M-D-Y)Mage Screening Demographics calculated Mother's Age datediff([dob],[visitdate],"y","mdy")Ethnicity Screening Demographics radio (single answer) EthnicityRace Screening Demographics checkbox (multiple answers) RaceInsurance Screening Demographics dropdown (single answer) InsuranceSpecimenscollected Screening Demographics Specimens Collected yesno Were specimens collected at this visit?Specimens Screening Demographics checkbox (multiple answers) Specimens collected Branching Logic: [specimenscollected]='1'SalivaCollectDate Screening Demographics text Saliva Collect Date Branching Logic: [specimenscollected]='1' and [specimens(1)]='1' Date(M-D-Y)DBSCollectDate Screening Demographics text DBS Collect Date Branching Logic: [specimenscollected]='1' and [specimens(2)]='1' Date(M-D-Y)

The Pediatrics Research OfficeThe PRO can provide you and your staff assistance in developing your REDCap projects. This may be one or two meetings for start up assistance or full assistance for the development and launching of your REDCap project. Additionally, the PRO can provide as much support as you need with the creation of the data collection instruments, data collection, data coding, data cleaning and data documentation depending on the time and funding allotted for such services.

Scheduling of group training in the use of REDCap is also available through the PRO.

Contacts: Emily Mixon, MPH – emixon@uab.edu phone: 996-7792

Dr. Karen Fowler – kfowler@uab.edu phone: 966-7791