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REDCap Introduction

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) …

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REDCap Introduction

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  1. REDCap Introduction By J KevanEssmyer Acknowledgements: Paul Harris (Vanderbilt CTSA) Jack Baty (WUSM REDCap Admin)

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

  3. 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.

  4. 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

  5. WUSM REDCap Installation Where is it

  6. REDCap Consortium http://project-redcap.org/

  7. 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

  8. Public HTTPS Survey Access Biostatistics Secure Domain WEB Server File Server https://redcapsurvey.wustl.edu... REDCap Survey MySQL Server Uploaded Files Authenticated Access Data Sync WEB Server WU Campus Data Entry /Admin MySQL Slave Server Data Entry /Admin Installation Files Sidedoor Server Host Server

  9. 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” • REDCapProject 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

  10. 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 REDCapadminstators.

  11. A brief tour of the system REDCap Selected Features

  12. 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

  13. Study Calendar – Participant Scheduling Participant Scheduling Module Optional Visit-Level View Shows Status + CRFs (Longitudinal Model)

  14. Online Form Designer

  15. Field Types

  16. Textbox Data Validation

  17. Branching Logic Creation Tool

  18. 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.

  19. Calculations • Simple • [weight]*10000/([height]*[height]) • Complex • Calculating the Mean of groups with null valid range includes zeroThe 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)))

  20. Built in Functions DATEDIFF F(x) Units Date Formats

  21. User Permissions “Rights”

  22. 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)

  23. 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

  24. 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)

  25. Creating Data Access Groups Add Group to Study Add User to Group Only one Group per user

  26. 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

  27. 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

  28. Data Comparison Tools Use Case: Double-Data Entry Studies

  29. DDE Merge Tool

  30. Custom Reports End-User Creation/Use of Custom Reports

  31. Reports

  32. Data Visualization / Cleaning

  33. Data Export + De-ID Tools EmbeddedDe-IdentificationTools Exports RawData + Stats Script Files (Labels, Coding

  34. Data Import Tools Use Cases: Convert DB to REDCapBatch Data Uploads

  35. Project File Repository Project-Specific Files Uploaded Here Data Export Files Auto-Saved Project-Specific Files Downloaded Here

  36. Data Quality Module (Data Queries)

  37. Results

  38. Data Quality Module (data queries)

  39. Expanded API Functionality

  40. Audit Trails / Data Logging Full Audit Logs – Data Changes and Page Views

  41. Top-Down and In-Line Video Training Resources

  42. Built-in User derived FAQ Resource

  43. Shared Library (Consortium) Public Consortium Site Search CuratedInstruments Scheduled for Release April, 2010 Annotated Records View as Web Page or PDF If coming from REDCap, May import to your study

  44. Treatment Randomization Module

  45. Creating a REDCap project Getting StaRTed

  46. 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.

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

  48. Web-Based Project Creation Point/ClickDrag (Ajax) For Real-time CRF Creation LongitudinalCRF Mapping Optional Participant SchedulingSetup Screens

  49. REDCap Setup Tools (Instantiate New Project ~ 15 sec)

  50. Project Setup Checklist Provides 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

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