Launch List

Beta - Phase I

Goal

• All workflows needed for IRB submission completed and ready to use
  • Includes Study Dashboard menu state based on PB cover sheet
• CRC Support will create scenarios for adequate coverage of key workflow

Assumptions

• UVA IT will deploy an instance for use that will be attached to PB in the IRB Sandbox
• Does not include fixes due to Git and _expression releases
• Performance issue has been addressed

Need to Complete

Core Information

• Library - Start and End workflows
• Ready for workflow testing and text review by UVA
  • Personnel
    • All access groups
    • Boolean Form Fields not loading or loading slowly - Ticket #627
  • Study Information
    • Blood Bank email check (ask if send again)
    • Summary
      • Study Information 500 error - Ticket #628
      • Blood Bank email date
  • ClinicalTrials.gov
  • IDE
  • IND
    • Shared Sponsor Enum workflow
  • Ancillary Services

Documents for IRB

• Library - Start and End workflows
• DocZip issue - Ticket #625
• Ready for workflow testing and text review by UVA
  • Protocol, Application & Cover Sheet
  • Data Security Plan
  • Consent Documents
    • End Event Summary - Not displaying Ancillary Docs
  • Drug/Deview Documents
  • Ancillary Documents
  • Form Documents
  • [xa] non-UVA IRB Documents
  • CTO Review

UVA Compliance Reviews for IRB

• Ready for workflow testing and text review by UVA
  • Department Chair
  • Blood Bank Approval
  • ESCRO Approval
  • FERPA/SBS Approval
  • GMEC Approval
  • GRIME Approval
  • IDS Waiver Application
  • IDS Approval
  • IBC Approval
  • Laser Safety Approval
    • End Event Approval metrics
  • NICU Committee Approval
    • enum_label() error
    • approval and denied notes
    • Reminder email error
  • New Medical Device Approval
  • PRC Approval
  • PRC Waiver
  • RDS-HIRE Approval
    • Committee Letter
    • Denied notes
  • RDRC Approval

Finance

• Ready for workflow testing and text review by UVA
  • Finance Information
  • Billing Coverage Analysis
    • Insert PI approval in spreadsheet
    • Reminder emails not working
  • Budget
  • Contract Number and Date
  • External Funding
  • eNFA Confirmation
  • eNFA Number and Date
  • PTAO Entry
  • Sponsor Funding Source
    • Needs Summary

Metrics

• Log workflow start and end on all Phase I workflows
• Log email sent on all Phase I workflow
• Improve log view in Study Dashboard

Instance Configuration

• DevOps (set-up instructions) to UVA

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Beta - Phase II

Goal

Assumptions

Production Launch

Goal

Assumptions

Need to Complete

Core Information

• Address Phase I issues
  • Personnel
  • Study Information
    • Remove COVID association Documents for IRB
• Ready for workflow testing and text review by UVA
  • Recruitment Documents

Main Dashboard

• Study list filter and sort
• Study Dashboard Approval Workflows UI Update - Ticket #606

Study Dashboard

• Document history

Documents for IRB

• Ready for workflow testing and text review by UVA
  • Recruitment Documents

UVA Compliance Reviews for IRB

• Ready for workflow testing and text review by UVA
  • COVID-19 Approval
  • Marketing Materials Approval
  • MR Physicist Approval

Finance

• Ready for workflow testing and text review by UVA
  • Grant Pricing Request

Submission to IRB

• IRB Pro API monitoring
• Update workflow status based on IRB Pro API monitoring
• Pre-Review Submission to IRB
• Read-Only locks
• Zip files
• Document submission report

Metrics

• Download filtered and sorted metrics log to spreadsheet
• Validate that Lori's report can be duplicated

Support

• Ability to add Admins
• Email history