2 Coversheet Documents

calexh-sar edited this page 2021-04-22 22:55:38 -04:00

Table of Contents

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

Protocol Builder Interface

This workflow relies on at least one of the following documents is on the PB Coversheet.

• New Medical Device

CRC1 Stats

Document	In CRC1 Study
New Medical Device	9%

Study Dashboard Menu Dependencies

State	Condition
required
disabled
hidden

Workflow Description

Generated Documents

No documents are generated 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