REDCap Version 5.

6.X

By J Kevan Essmyer Acknowledgements: Paul Harris (Vanderbilt CTSA) Jack Baty (WUSM REDCap Admin)

Left Panel User Control Menus Case Report Form / Activity Panel

647 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

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 • No limit on the number of projects 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

Public HTTPS Survey Access https://redcap.biostat.

wustl.edu

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 (Fax or email) – Sponsoring PI – Username /password – Open access to the Development server • Off-campus Access – Sidedoor security certificate – Access from any “capable” Internet connection (world wide) Production “Data Collection” • REDCap Project Request form (Fax or email) – 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

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

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

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

Templates

Templates

• • Several default templates will be available immediately.

Projects can be modified once created.

Record Status Dashboard

Record Status Dashboard

Study Calendar – Participant Scheduling

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

Multiple Surveys Projects

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

Automated Survey Invitation Conditions

Custom Reports

End-User Creation/Use of Custom Reports

Reports

Data Visualization / Cleaning

Data Export + De-ID Tools

Embedded De-Identification Tools Exports Raw Data + Stats Script Files (Labels, Coding

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

Textbox Data Validation

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

User Permissions “Rights”

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)

Data Comparison Tools

Use Case: Double-Data Entry Studies

DDE Merge Tool

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

Creating a REDCap project

GETTING STARTED

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."

• • • • • • •

Getting Started

Submit Request forms – User and/or Project access request forms 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 User 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.

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

Move to Production Status

• Production Status on the Production Server • Data dictionary changes are stored by the system • Global deletion of data from system prohibited • Changes to forms must be approved by Administrators before they are committed to the project.

• Changes to the Forms/ Event Grid must be preformed by the Administrators.

WUSM HIPAA Compliance

• • • • Password protected User accounts – Customizable User Permissions SSL encrypted data transmissions – Browser   Server Detailed Activity Logs – Data Creation/Update/Deletion/Views/Downloads Data Access Groups – Limit users data access specific groups of Participants

REDCap Lifelines

• • • • Built-in tutorial videos Built-in Frequently Asked Question (FAQ) guide Demonstration Databases (Some Online, more to come, on demand) WUSM Biostat REDCap Email Help Queue – [[email protected]] – Monitored by 4 to 5 Administrators

Top-Down and In-Line Video Training Resources

Built-in User derived FAQ Resource

REDCap Email Support [email protected]

REDCap Goals

• • • • • Easy to use Metadata Driven Adaptable Features Data entry validation Self service tool

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/)

Creating Data Access Groups

• • • Add Group to Study Add User to Group Only one Group per user

Data Access Group Data Entry

• • • Users only have access to their groups data.

!!!Users Not assigned to a group have access to all records according to their “User Rights”!!!

Multiple accounts available for Study Managers

Double Data Entry Module

• Standard method – Supports only two data entry participants per REDCap Project – Option for those creating individual project for each site • Modified usage – Create duplicate record with “comparison” or prefix/postfix – Use comparison tool to compare records. – Any user with data entry rights can do DDE

Results

Data Quality Module (data queries)

Expanded API Functionality

REDCap Setup Tools (Instantiate New Project ~ 15 sec)

Provides a general to-do list during project creation

Project Setup Checklist

Create hyperlinks to web pages or other REDCap projects All users permissions for data access configured here

User Permissions “Rights”

Variable names must be in lower case and cannot be repeated in the data dictionary regardless of which form it is on.

Online Form Designer

First data element in the first form is consider the study ID

File-Based Project Creation

Project Data Dictionary

• Spreadsheet contains all the meta data necessary for REDCap to create data forms • Quick transfer or modification of forms • Moving forms between REDCap Servers • Complicated Form modifications • Adding or removing multiple fields • Move fields from one form to another

Forms Ready for Data

REDCap CRF

Record Locking

• Records can be lock by designated users to prevent further data entry change to specified forms • ***WUSM Software installation is not currently configured for serving as a electronic source document system. (FDA 21 CFR Part 11 Electronic Records compliant)

Creating a REDCap project

GETTING STARTED

Calculations

• •

Simple [weight]*10000/([height]*[height])

•

Complex

•

Calculating the Mean of groups with null valid range includes zero

The following equation will calculate the Mean of a list of variables • ) / ( (if(Math.abs([A])>0,[A],0)) +(if(Math.abs([B])>0,[B],0)) +(if(Math.abs([C])>0,[C],0)) ) ( (if(Math.abs([A])>0,1,if([A]=0,1,0)) +if(Math.abs([B])>0,1,if([B]=0,1,0)) +if(Math.abs([C])>0,1,if([C]=0,1,0))

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)