1 Study Documents

ajski edited this page 2021-06-21 10:35:53 -04:00

Includes COI Management Plan and "As Applicable Study Documents"

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