2 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…
3 Need for Data Capture Software Convenient uniform data entry methodStateless web-basedSecure WUSM HIPAA compliant centralized data store.Easy to use multi-purpose clinical databaseNot Excel, Not Access, Not 3-4 composition notebooks somewhere on the top shelfReduce data “cleaning” effort during analysis.
4 REDCap System (What is it?) Easy to use, web based Research data capture systemMetadata (Form) driven data store developmentGeneric clinical data system with adaptable features covering Surveys, Cross-sectional, and longitudinal study modelsProvides 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
6 WUSM REDCap Servers (http://www.biostat.wustl.edu/redcap) Development “Trying it Out”HIPAA Secure serverREDCap User Request form (Fax or )Sponsoring PIUsername /passwordOpen access to the Development serverOff-campus AccessSidedoor security certificateAccess from any “capable” Internet connection (world wide)Production “Data Collection”REDCap Project Request form (Fax or )Sponsoring PIIRB Approval or WaiverOnly PI or Project Admin can create projectsProduction “Status”Data DictionaryChanges savedReview of submitted changes to avoid unintended data corruptionDelete all records function disallowed
7 Move to Production Status “Production Status” on the Production ServerData dictionary changes are stored by the systemGlobal deletion of data from system prohibited“High Risk” changes to forms must be approved by Administrators before they are committed to the project.Changes to the Forms/ Event GridEvents may be added but not removed
8 Current Usage CostsOffered 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 fileNo limit on the number of projects per study.Basic technical support and usage guidance provided by REDCap adminstators.
9 Treatment Randomization Module Stratified RandomizationUse up to 14 project fieldsMultiple Choice fieldsGroup StratificationsData Access groupsDesignated Multiple Choice Grouping FieldRandomization TemplateGenerated based on selected criteriaDevelopment and Production TablesOnce in Production status treatment Allocation tables are locked
10 Enable Randomization Feature in Project Settings
19 Getting Started Enable Randomization Select Fields Select Data Entry Forms projectSet “User Rights” for users who will administer and setup the randomizationsSelect FieldsUp to 14 strata fieldsSet grouping if applicableSet Treatment FieldAllocation TemplatesSave randomization modelDownload Allocation templates and replace content according to study protocolUpload Development/Production allocation tablesTables become locked once project is put into Production StatusRandomization fields clearMonitor RandomizationDashboard
20 “?!!?” Branching Logic Data Validation User Rights API Data Dictionary SchedulingData Dictionary
21 REDCap Lifelines Built-in tutorial videos Built-in Frequently Asked Question (FAQ) guideDemonstration Databases (Some Online, more to come)WUSM Biostat REDCap Help QueueMonitored by 4 to 5 Administrators