2 Informational

calexh-sar edited this page 2021-03-31 13:55:41 -04:00

Table of Contents

• Business Requirements
• Protocol Builder Interface
• CRC1 Stats
• Study Dashboard Menu Dependencies
• Workflow Description
• Documents

Business Requirements

Protocol Builder Interface

This workflow does not rely on data from PB.

CRC1 Stats

This workflow does not have any CRC1 stats.

Study Dashboard Menu Dependencies

State	Condition
optional	Always

Workflow Description

Documents

No documents are produced from this workflow.

Home
Template

• Study Info
• Personnel
• Core Info Workflow
• ClinicalTrials.gov
• IDE
• IND
• Informational

• Finance Info & Documents
• Finance
• Billing Coverage Analysis (BCA)
• Budget
• Contract
• External Funding
• Grant Pricing Request (GPR)
• Non-Funded Agreement
• PTAO Entry
• Sponsor Funding Source

• UVA Compliance Reviews for IRB
• Department Chair Approval
• Coversheet Approvals
• UVA Compliance Reviews
• ESCRO Approval
• GRIME Outcome
• GMEC Outcome
• IDS Waiver
• Investigational Drug Services
• Institutional Biosafety (IBC) Outcome
• Neonatal ICU Committee (by NICU)
• Non-UVA Institutional Approval: Initial and Last Continuation
• RSC/HIRE Standard Radiation Language
• SOM CTO Review and Outcome (by CTO)

• Documents for IRB
• Protocol Application and Coversheet
• Data Security Plan
• Study Documents
• COI Management Plan
• Consent Documents
• Drug/Device Documents
• Ancillary Documents
• FDA Certificate of Confidentiality
• Non UVA IRB
• Other Documents
• Reviewing IRB Approval to add UVA as Relying Site THIS IS AFTER PRE-REVIEW

• Unsorted
• Protocol Builder Data
• FERPA/SBS Outcome
• Contracts
• Coversheet Documents
• New Medical Device
• Radioactive Drug Research Committee (RDRC)
• IRB Reliance Agreement Request Form: Non-UVA IRB as IRB of Record