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

REDCap

Publications

Researcher

Statistical Analysis

Write Conclusion

Define Forms/Data

Define Procedure/Events

Set User Access

Capture Data

Query/Correct Data

Spreadsheet/

Custom DB

Find Problem

Fix Problem

Eventually$$$

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

File Server

Host Server

WEB Server

Uploaded Files

Installation Files

https://redcap.biostat.wustl.ed

u

Data Entry / Admin / Surveys

MySQL Server

MySQL Slave Server

Data

Sync

Biostatistics Secure DomainPublic HTTPS Survey Access

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

Project Setup ChecklistProvides a general to-do list during project creation

Create hyperlinks to web pages or other REDCap projects

Select Cross-sectional or LongitudinalProject Data Model

--Online Designer

--Link to REDCap Shared Library

--Enable optional project features

Cross-sectional and LongitudinalProject 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 OptionalVisit-Level View Shows Status + CRFs (Longitudinal Model)

Multiple Surveys ProjectsSurvey Server

Event 1-First Form

Anonymous Link

Participant List Invitation

Creates Participant Record

Follow Up Surveys

Designated Email Field

Participant List Email Address

Adds Data to Existing Record

Multiple Surveys Per Event

Asynchronous Requests

Scheduled Email

Logic TriggerDataEvent

Schedule

Unique Survey URL

Automated Survey Invitation Conditions

Custom Reports

End-User Creation/Use of Custom Reports

Reports

Data Visualization / Cleaning

Data Export + De-ID Tools

Exports RawData + StatsScript Files(Labels, Coding

EmbeddedDe-IdentificationTools

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

CalculationsCalculations 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

"y" years 1 year = 365.2425 days

"M" months 1 month = 30.44 days

"d" days

"h" hours

"m" minutes

"s" seconds

"ymd" Y-M-D (default)

"mdy" M-D-Y

"dmy" D-M-Y

Type of calculation Notes / examples

round(number,decimal places) Round

roundup(number,decimal places) Round Up

rounddown(number,decimal places) Round Down

sqrt(number) Square Root

(number)^(exponent) Exponents

abs(number) Absolute Value

min(number,number,...) Minimum

max(number,number,...) Maximum

mean(number,number,...) Mean

median(number,number,...) Median

sum(number,number,...) Sum

stdev(number,number,...) Standard Deviation

datediff([date1], [date2], "units", "dateformat", returnSignedValue)

datediff([dob],[date_enrolled],"d")

datediff([dob],"05-31-2007","h","mdy",true)

Units

Date Formats

DATEDIFF F(x)

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 CuratedInstruments

Annotated Records

View as Web Page or PDF

If coming from REDCap,May import to your study

Scheduled for ReleaseApril, 2010

Treatment Randomization Module

GETTING STARTEDCreating a REDCap project

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 SpreadsheetOr

Online Form Designer

Data EntryForms

Add Users and

Set User Rights

Test

Forms

Move to Production Status and start Data Collection

Define Study Events

(Longitudinal)

add Schedule (optional)

Web-Based Project Creation

Point/ClickDrag (Ajax)For Real-timeCRF Creation

Optional ParticipantSchedulingSetup Screens

LongitudinalCRF Mapping

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– [redcap@rt.biostat.wustl.edu]– Monitored by 4 to 5 Administrators

Top-Down and In-Line Video Training Resources

Built-in User derived FAQ Resource

REDCap Email Support

redcap@rt.biostat.wustl.edu

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 Barnes-Jewish Hospital

and 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)

Project Setup ChecklistProvides a general to-do list during project creation

Create hyperlinks to web pages or other REDCap projects

All users permissions for data access configured here

User Permissions “Rights”

Online Form DesignerFirst data element in the first form is consider the study ID

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

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)

GETTING STARTEDCreating a REDCap project

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 SpreadsheetOr

Online Form Designer

Data EntryForms

Add Users and

Set User Rights

Test

Forms

Move to Production Status and start Data Collection

Define Study Events

(Longitudinal)

add Schedule (optional)