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REDCap Treatment Randomization Module

REDCap Treatment Randomization Module

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REDCap Treatment Randomization Module

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  1. REDCap Treatment Randomization Module 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. 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

  6. 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

  7. 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 • “High Risk” changes to forms must be approved by Administrators before they are committed to the project. • Changes to the Forms/ Event Grid • Events may be added but not removed

  8. 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.

  9. Treatment Randomization Module • Stratified Randomization • Use up to 14 project fields • Multiple Choice fields • Group Stratifications • Data Access groups • Designated Multiple Choice Grouping Field • Randomization Template • Generated based on selected criteria • Development and Production Tables • Once in Production status treatment Allocation tables are locked

  10. Enable Randomization Feature in Project Settings

  11. Set up Randomization on Project Setup Screen

  12. Randomization User Rights • Randomization Rights • Setup up allocation tables • Create and load Trt allocation tables • View current randomization Status • Check progress of randomization • Randomize Participant

  13. Treatment Randomization Module

  14. Select and Save Criteria

  15. Download Allocation Table Template Example allocations !! You will need to assign your treatment allocations based on your project’s statistical analysis plan

  16. Upload Allocation Tables Duplicate allocations !! You may not use the exact same allocation table for Production status that you used in Development status

  17. Randomize Participant

  18. Randomization Dashboard

  19. Getting Started • Enable Randomization • Select Data Entry Forms project • Set “User Rights” for users who will administer and setup the randomizations • Select Fields • Up to 14 strata fields • Set grouping if applicable • Set Treatment Field • Allocation Templates • Save randomization model • Download Allocation templates and replace content according to study protocol • Upload Development/Production allocation tables • Tables become locked once project is put into Production Status • Randomization fields clear • Monitor Randomization • Dashboard

  20. “?!!?” Branching Logic Data Validation User Rights API Data Dictionary Scheduling

  21. REDCap Lifelines • Built-in tutorial videos • Built-in Frequently Asked Question (FAQ) guide • Demonstration Databases (Some Online, more to come) • WUSM BiostatREDCap Email Help Queue • [redcap@rt.biostat.wustl.edu] • Monitored by 4 to 5 Administrators

  22. REDCap Email Support redcap@rt.biostat.wustl.edu

  23. REDCap Goals • Easy to use • Metadata Driven • Adaptable Features • Data entry validation • Self service tool Questions?