REDCap Version 6.1

.X

By J Kevan Essmyer Acknowledgements: Paul Harris, (Vanderbilt CTSA) Phil Miller, (Biostatistics Division Faculty Sponsor) Jack Baty, (WUSM REDCap Admin) Yu Tao, (WUSM REDCap Admin) Ningying Wu, (WUSM REDCap Admin)

1243 Consortium Partners

Why Use REDCap?

• Provides researchers a tool that..

– Defines forms/data – – Controls user access to data Captures data entry – Validates fields – Checks/Queries data – Stores data – Exports data for analysis …Researchers are good people, give them a good tool and they will do good things….

- Paul Harris Vanderbilt

Researcher

Fix Problem

$$$

Find Problem

Spreadsheet / Custom DB

REDCap

Define Forms/Data Define Procedure/Events Set User Access Capture Data Query/Correct Data Write Conclusion Statistical Analysis Publications

Data Forms

General Purpose Data Base with Clinical Bias

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

Current Usage Costs

• Offered as an Investigator Resource for Washington University Institute of Clinical and Translational Sciences(ICTS) and Siteman Cancer Center (SCC) members.

• No charge for data or file storage.

– Individual upload file size currently limited to 32MB 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 appropriate Division of Biostatistics Consulting Mechanisms

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

Left Panel User Control Menus Case Report Form / Activity Panel

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

Project Setup Checklist

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

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 Anonymous Link Participant List Invitation Creates Participant Record Scheduled Email Logic Trigger Data Event Schedule Follow Up Surveys Participant List Email Address Designated Email Field Adds Data to Existing Record Multiple Surveys Per Event Asynchronous Requests

User Permissions “Rights”

Custom Reports

End-User Creation/Use of Custom Reports

Custom Reports

End-User Creation/Use of Custom Reports

Data Visualization / Cleaning

Online Form Designer

Field Types

Data Dictionary Spreadsheet

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

Branching Logic Creation Tool

Calculations

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.

Type of calculation

round(number,decimal places) roundup(number,decimal places) rounddown(number,deci mal places) sqrt(number)

Built in Functions

DATEDIFF F(x)

Notes / examples datediff([date1], [date2], "units", "dateformat", returnSignedValue) Round Round Up Round Down Square Root datediff([dob],[date_enrolled],"d") datediff([dob],"05-31-2007","h","mdy",true)

Units

"y"

"M"

years

months

1 year = 365.2425 days

1 month = 30.44 days (number)^(exponent)

Exponents

"d" days abs(number)

Absolute Value

"h" hours min(number,number,...)

Minimum

"m" minutes max(number,number,...) mean(number,number,...

) median(number,number,.

..) sum(number,number,...)

Maximum Mean Median Sum

"s"

"ymd"

Date Formats "mdy" "dmy" seconds

Y-M-D (default)

M-D-Y stdev(number,number,...) Standard Deviation D-M-Y

REDCap Shared Form Library

http://projectredcap.org

Demo Survey

Creating a REDCap project

GETTING STARTED

Project Creation Flow Chart

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

Web-Based Project Creation

Point/Click Drag (Ajax) For Real-time CRF Creation Longitudinal CRF Mapping Optional Participant Scheduling Setup Screens

Public HTTPS Survey Access https://redcap. wustl.edu

WUSM Secure Campus Network Biostatistics Secure Domain File Server MySQL Server WEB Server MySQL Slave Server Host Server

WUSM REDCap Servers

( http://www.biostat.wustl.edu/redcap ) Development “Trying it Out” • • HIPAA Secure server REDCap User Request form – Sponsoring PI – Username /password – Open access to the Demo server • Off-campus Access – Access from any “capable” Internet connection (world wide) • • No Active Surveys!

No Production “Status”!

Production “Data Collection” • REDCap Project Request form – Sponsoring PI – IRB Approval or Waiver – Only PI or Project Admin can create projects • Production “Status” – Data Dictionary • Changes saved • Review of submitted changes to avoid unintended data corruption • Delete all records function disallowed

• • • • • • •

Getting Started

Submit Account Requests: [http://www.biostat.wustl.edu/redcap/?page_id=43] – – 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.

Top-Down and In-Line Video Training Resources

REDCap Email Support [email protected]

REDCap Goals

• • • • • Easy to use Metadata Driven Adaptable Features Data entry validation Self service tool…(User Driven)

Questions?

Acknowledgements

• Siteman Cancer Center Member – The Alvin J. Siteman Cancer Center at Hospital and Barnes-Jewish Washington University School of Medicine ( http://www.siteman.wustl.edu/about-us.aspx#sthash.spgPKuBy.dpuf) • Institute of Clinical and Translational Sciences Member – The Clinical and Translational Science Award program, funded by the National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health (NIH) (http://http://icts.wustl.edu/)

…A Slide Too Far

STOP!

You’ve Gone Past the last Slide!

….Backup

Extra Slides

Textbox Data Validation

User Roles

Define custom roles for different user types (Data entry, PI, Monitor…)

Supporting Multi-Site

• • • • • Data Access Group Partitions Double Data Entry – Standard and modified usage SSL enabled Secure Server for Internal and External Campus access Configurable Individual “User Rights” Multiple access levels – System Access –granted by the REDCap Administrators – – Project Access –granted by Project Administrator User Rights –set by Project Administrator

Data Access Groups

• Partition data records among groups of users • Each group can only see the data associated with the group they belong to.

• Each user can only belong to one group • “Global” users can be created for cross site management. (i.e. Any user not restricted to a Group)

Project File Repository

Project-Specific Files Uploaded Here Project-Specific Files Downloaded Here Data Export Files Auto-Saved

Data Quality Module (Data Queries)

Audit Trails / Data Logging

Full Audit Logs – Data Changes and Page Views

Shared Library (Consortium)

Public Consortium Site Search Curated Instruments

Scheduled for Release April, 2010

Annotated Records View as Web Page or PDF If coming from REDCap, May import to your study

Treatment Randomization Module

BEST Practices

• • • • • • • • • Consider carefully the amount of data to collect per visit, per event, and overall in every clinical trial Avoid crowding questions Consider the use of closed versus open systems (i.e., forced-choiced questions) Use consistent units of measurement Avoid requiring the respondent to make calculations whenever possible Avoid mixing timeframes in a single section Consider the consequences of creating incomplete or inadequate data collection forms Collect relevant information to address trial objectives at the time of the trial Differentiate between Unknown, Uncertain, and Missing data instead of using the phrase "Not Available“ – Spilker and Schoenfelder • also give a list of the following helpful pointers which they believe, "refer to issues to consider

to assess whether the point is relevant to a particular clinical trial."