Introduction to. Sponsored by the Pediatric Research Office (PRO)

Transcription

1 Introduction to Sponsored by the Pediatric Research Office (PRO)

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

3 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.

4 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

5 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

6 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.

7 Costs: Charge: Project development Data Management of the project

8 Security: Managed by the Department of Pediatrics IT 3-Tiered Access System Login Project Access User Restrictions Audit Trails Logging feature De-identified Data Identify variables as PHI Export de-identified data

9 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

10 PRO Responsibilities: Approve and establish new user accounts Periodically request REDCap upgrade of PEDS IT Provide basic training to end users

11 REDCap FLOW

12 Creating a project with REDCap First, decide on the data that you need to collect that will answer your research question!

13 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, , expected study visits, etc. This information likely does not need to be in your permanent research study data base.

14 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

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19 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

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24 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

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26 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.

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28 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

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30 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

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33 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.

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35 Design your Data Collection Instruments:

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37 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

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

39 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

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42 Pre-Production: Project Setup Tab Design data collection instruments Test Instruments Assign User Rights Move project to production status

43 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

44 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

45 My First Practice Instrument Log into REDCap using the following link:

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48 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)

49 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)

50 The Pediatrics Research Office The 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 phone: Dr. Karen Fowler phone: