Acknowledgements Paul Harris Vanderbilt CTSA 1875 Consortium Partners

Acknowledgements: Paul Harris, (Vanderbilt CTSA)

1875 Consortium Partners Institutions 100 Countries

Why Use REDCap? • Provides researchers a tool that. . – Defines forms/data – Controls user access to data – Captures data entry – Validates fields/ Data Queries – Stores data – Exports data for analysis – Mobile App …Researchers are good people, give them a good tool and they will do good things…. --Paul Harris Vanderbilt

Researcher REDCap Define Forms/Data Define Procedure/Events Set User Access Fix Problem $$$ Find Problem Capture Data Spreadsheet / Custom DB Eve Query/Correct Data ntu ally Write Conclusion Statistical Analysis Publications

General Purpose Data Base with Clinical Bias Web Surveys Activity Logging PDF of Blank or Completed forms Data Import / Export De-Identified Data Export Data Forms User Management Data Access Groups / Multi-Site Access Custom Reports REDCap Project Data Quality Queries / Resolution API Interface / Custom Programs REDCap Application (Hosts Multiple REDCap Projects) PHI Field Restriction Formatted Export (SAS, SPSS, R, Excel) Branching / Skip Logic

General Purpose Data Base with Clinical Bias Bioportal Ontology lists Twilio Phone and SMS Surveys ODM XML Import / Export Data Import / Export API Interface / Custom Programs Mobile App REDCap Project User Management REDCap Application (Hosts Multiple REDCap Projects)

Current Usage Costs • No charge for data or file storage. – Individual upload file size currently limited to 32 MB per file – No limit on number of upload files • Multiple Databases per study. • Basic technical support and usage guidance provided by REDCap administrators. – Study design and analysis services provided via research clinic from Epidemiology and biostatistics unit

Existing REDCap Features • • • Calendar Scheduling tool Online Graphical Form designer Multiple data types supported Built-in data validation for special text fields (phone, email, SSN, numeric, …etc. ) Branching Logic to conditionally show/hide fields Calculation Fields Configurable user permission levels Record Locking Record Change Confirmation • Report Builder • Graphical data viewing tool • Simple data Import / Export mechanism • Data quality query system for checking data integrity • API interface for integration with other data systems. • Detailed logging routines for monitoring data creation, modification, deletion and viewing. • Integrated software instructions, FAQ, video tutorials.

Features --Continued • User Rights Templates • User grouping for multi-site data access restrictions • Double Data Entry support • Project Templates • Variable Piping • Data queries – Data Error Detection – Data Resolution Work Flow • Curated Shared Forms Library • Treatment Randomization Module • Multiple Surveys • Survey scheduler – Logic/Event/Data driven • Data entry triggers – Automated program calls

Projects

Left Panel User Control Menus Case Report Form / Activity Panel

Project Setup Checklist Provides a general to-do list during project creation Select Cross-sectional or Longitudinal Project Data Model --Online Designer --Link to REDCap Shared Library --Enable optional project features Create hyperlinks to web pages or other REDCap projects

Cross-sectional and Longitudinal Project Data Models

Data Import Tools Use Cases: Convert DB to REDCap Batch Data Uploads

Data Export Tools Use Cases: Export data with pre-built import syntax file

Templates • Several default templates will be available immediately. • Projects can be modified once created. • Templates created from Existing projects

Record Status Dashboard

Study Calendar – Participant Scheduling Module Optional Visit-Level View Shows Status + CRFs (Longitudinal Model)

Multiple Surveys Per Project Unique Survey URL Survey Server Event 1 -First Form Follow Up Surveys Anonymous Link Participant List Email Address Participant List Invitation Designated Email Field Scheduled Email Creates Participant Record Logic Trigger Data Event Schedule Adds Data to Existing Record Multiple Surveys Per Event Asynchronous Requests

User Permissions “Rights”

Custom Reports End-User Creation/Use of Custom Reports

Data Visualization / Cleaning

Online Form Designer

Data Dictionary Spreadsheet • Combine/edit project forms • Share forms with other investigators • Access same metadata and functionality as the online designer tool

Field Types

Branching Logic Creation Tool

Calculations are preformed on the web browser during data entry. Form must be submitted to saved in the project data. Calculated field should be considered a form tool. All calculations should be re-applied by statistical software during formal analysis/reporting phase.

Built in Functions Type of calculation Notes / examples round(number, decimal places) Round roundup(number, decimal Round Up places) rounddown(number, deci mal places) Round Down sqrt(number) Square Root DATEDIFF F(x) datediff([date 1], [date 2], "units", "dateformat", return. Signed. Value) datediff([dob], [date_enrolled], "d") datediff([dob], "05 -31 -2007", "h", "mdy", true) Units "y" years 1 year = 365. 2425 days "M" months 1 month = 30. 44 days (number)^(exponent) Exponents abs(number) Absolute Value "d" days min(number, . . . ) Minimum "h" hours max(number, . . . ) Maximum "m" minutes mean(number, . . . ) Mean "s" seconds median(number, number , . . . ) Median sum(number, . . . ) Sum stdev(number, . . . ) Standard Deviation Date Formats "ymd" Y-M-D (default) "mdy" M-D-Y "dmy" D-M-Y

REDCap Shared Form Library http: //projectredcap. org

Demo Survey

MOBILE APP STORE

Mobile App Requirements • You must first download the REDCap mobile app on your i. OS or Android device. – Android 4. 3 or later (phones and tablets). – i. OS 6. 0 or later (i. Phone 4 and up, i. Pad 2 and up) – Not Available for Chrome OS at the moment • Project User Rights – Mobile App – API import/export token - (not required) • Uses same token as Mobile App • (Do not reset token with new data on App. )

Project Creation Flow Chart Create Project –Project Name, Longitudinal or Cross-Sectional/ Survey Move to Production Status and start Data Collection Excel Spreadsheet Or Online Form Designer t Tes s m For Data Entry Forms Add Users and Set User Rights Define Study Events (Longitudinal) add Schedule (optional)

Creating a REDCap project GETTING STARTED

Getting Started • Submit Account Requests – User Account—per person – Project Account – designate PI/PA per Study • Create Project – Select Usage, Type, Data Model, and Scheduling option • Create Forms – Online designer to graphically create forms – Spreadsheet template for advance and large form changes – Forms per event designations • Set Security Rights – Data access, Import/Export Rights, Data Access Groups – Form level access • Tests forms (Thorough testing will help avoid deployment delays) • Move to Production “Status” • Start Collecting Data.