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REDCap Version 5. 6.X

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..

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REDCap Version 5. 6.X

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  1. REDCap Version 5.6.X By J Kevan Essmyer Acknowledgements: Paul Harris (Vanderbilt CTSA) Jack Baty (WUSM REDCap Admin)

  2. Left Panel User Control Menus Case Report Form / Activity Panel

  3. 647 Consortium Partners

  4. 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

  5. Researcher REDCap Define Forms/Data Define Procedure/Events Set User Access Fix Problem Capture Data Spreadsheet / Custom DB Query/Correct Data $$$ Eventually Write Conclusion Find Problem Statistical Analysis Publications

  6. 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

  7. Public HTTPS Survey Access Biostatistics Secure Domain https://redcap.biostat.wustl.edu File Server MySQL Server Uploaded Files Data Data Entry / Admin / Surveys Sync WEB Server MySQL Slave Server Installation Files Host Server

  8. 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

  9. 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.

  10. 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

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

  12. Data Export Tools Use Cases: Export data with pre-built import syntax file

  13. Project Setup Checklist Provides a general to-do list during project creation Select Cross-sectional or LongitudinalProject Data Model --Online Designer --Link to REDCap Shared Library --Enable optional project features Create hyperlinks to web pages or other REDCap projects

  14. Cross-sectional and LongitudinalProject Data Models

  15. Templates

  16. Templates • Several default templates will be available immediately. • Projects can be modified once created.

  17. Record Status Dashboard

  18. Record Status Dashboard

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

  20. Multiple Surveys Projects Survey Server Unique Survey URL Event 1-First Form Follow Up Surveys Participant List Email Address Anonymous Link Participant List Invitation Designated Email Field Scheduled Email Logic Trigger Data Event Schedule Creates Participant Record Adds Data to Existing Record Multiple Surveys Per Event Asynchronous Requests

  21. Automated Survey Invitation Conditions

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

  23. Reports

  24. Data Visualization / Cleaning

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

  26. Online Form Designer

  27. Data Dictionary Spreadsheet • Combine/edit project forms • Share forms with other investigators • Access same metadata and functionality as the online designer tool

  28. Field Types

  29. Textbox Data Validation

  30. Branching Logic Creation Tool

  31. 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.

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

  33. User Permissions “Rights”

  34. User Roles Define custom roles for different user types (Data entry, PI, Monitor…)

  35. 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

  36. 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)

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

  38. DDE Merge Tool

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

  40. Data Quality Module (Data Queries)

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

  42. 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

  43. Treatment Randomization Module

  44. Creating a REDCap project Getting StaRTed

  45. 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“ • Spilkerand 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."

  46. 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.

  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. 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.

  50. 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

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