34 Launch List
calexh-sar edited this page 2022-03-11 15:44:27 -05:00

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

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