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

REDCap Introduction

By J Kevan Essmyer

Acknowledgements:Paul Harris (Vanderbilt CTSA)

Jack Baty (WUSM REDCap Admin)

Overview

• What is it…• Where is it…• What are the costs…• REDCap Features (A brief tour of the system)…• Getting Started (Creating a REDCap project)…• Demonstration…

Need for Data Capture Software

• Convenient uniform data entry method– Stateless web-based– Secure WUSM HIPAA compliant centralized data

store. • Easy to use multi-purpose clinical database– Not Excel, Not Access, Not 3-4 composition

notebooks somewhere on the top shelf • Reduce data “cleaning” effort during analysis.

REDCap System(What is it?)

• Easy to use, web based Research data capture system • Metadata (Form) driven data store development• Generic clinical data system with adaptable features

covering Surveys, Cross-sectional, and longitudinal study models

• Provides data validation at time of entry, and user based data access restrictions.

• Provides easy mechanism to view and export data in a variety of formats for common analysis tools.

• Designed to be a self service tool

WHERE IS ITWUSM REDCap Installation

REDCap Consortium

http://project-redcap.org/

WUSM REDCap Installation

• Active installation since November 2009 • Currently have 1200+ users• System hosted on local secure WU servers

behind multiple firewalls• Daily differential backup

File Server

Host Server

WEB Server

Uploaded Files

Installation Files

WEB Server

WU Campus

Sidedoor Server

https://redcapsurvey.wustl.edu...

REDCap Survey

Data Entry /Admin

Data Entry /Admin

MySQL Server

MySQL Slave Server

Data

Sync

Biostatistics Secure Domain

Authenticated Access

Public 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

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.– File size currently limited to 32MB per file

• No limit on the number of projects per study.

• Basic technical support and usage guidance provided by REDCap adminstators.

REDCAP SELECTED FEATURESA brief tour of the system

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 • User grouping for multi-site data

access restrictions• Double Data Entry support

• 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.

• Curated Shared Forms Library• Treatment Randomization Module

Study Calendar – Participant Scheduling

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

Online Form Designer

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.

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)))

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”

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)

Supporting Multi-Site

• Data Access Group Partitions• Double Data Entry– Standard and modified usage

• Sidedoor Secure Server for 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)

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

Data Comparison Tools

Use Case: Double-Data Entry Studies

DDE Merge Tool

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

Data Import Tools

Use Cases: Convert DB to REDCap Batch Data Uploads

Project File Repository

Project-Specific Files Uploaded Here

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

Data Quality Module (Data Queries)

Results

Data Quality Module (data queries)

Expanded API Functionality

Audit Trails / Data Logging

Full Audit Logs – Data Changes and Page Views

Top-Down and In-Line Video Training Resources

Built-in User derived FAQ Resource

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

Getting Started• Submit Request forms

– User , Project, and or Sidedoor “off -campus” 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

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

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.

“?!!?”

User Rights

Branching

Logic

Scheduling

API

Data Dictionary

Data

Validation

REDCap Lifelines

• Built-in tutorial videos• Built-in Frequently Asked Question (FAQ)

guide• Demonstration Databases (Some Online, more

to come)• WUSM Biostat REDCap Email Help Queue– [[email protected]]– Monitored by 4 to 5 Administrators

REDCap Email Support

[email protected]

REDCap Goals

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

Questions?