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Page: Investigational Device Exemption
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Ancillary Documents Billing Coverage Analysis (BCA) Budget COI Management Plan ClinicalTrials gov Consent Documents Contracts Coversheet Approvals Coversheet Documents Data Security Plan Department Chair Approval Drug Device Documents ESCRO Approval External Funding FDA Certificate of Confidentiality FERPA SBS Outcome Finance GMEC Outcome GRIME Outcome Grant Pricing Request (GPR) Workflow Home IDE Info IDE IDS Waiver IND IRB Reliance Agreement Request Form: Non UVA IRB as IRB of Record Informational Institutional Biosafety (IBC) Outcome Investigational Device Exemption Investigational Drug Services Neonatal ICU Committee (by NICU) New Medical Device Non Funded Agreement Non UVA IRB Approval: Initial & Last Continuation Non UVA IRB Other Documents PTAO Entry Personnel Protocol Application and Coversheet Protocol Builder Data RSC HIRE Standard Radiation Language Radioactive Drug Research Committee (RDRC) Reviewing IRB Approval to add UVA as Relying Site SOM CTO Review and Outcome (by CTO) Sponsor Funding Source Study Documents Template UVA Compliance Reviews
2 Investigational Device Exemption
calexh-sar edited this page 2021-04-18 23:55:52 -04:00
Table of Contents

Business Requirements

  • One IDE with one Holder shall be required for a study when the IRB PB Coversheet requires an IDE.
  • Each Investigational Device will have one Holder Type selected from the following list
    • Industry
    • UVA PI
    • Other PI
    • UVA Center
    • Other Colleges and Universities
    • IDE not exempt, but no IDE#
    • IDE Exempt
  • Each Investigational Device will have a device name
  • If applicable, each Investigational Device will have a Holder name.

Protocol Builder Interface

If the Coordinator specify in PB an Investigational Device is used in the study, the IRB API Details variable IS_IDE is set to 1 (true). If true, PB provides a field to enter the IDE #, if available, in the IRB API Details variable IDE. The Coordinator is also asked if the device was developed at UVA, and if so, the IRB API Details variable IS_UVA_IDE is set to 1 (true).

CRC1 Stats

This workflow does not have any CRC1 stats.

Study Dashboard Menu Dependencies

State Condition
required IRB API Details variable IS_IDE is 1
hidden IRB API Details variable IS_IDE is 0 or Null

Workflow Description

Documents

No documents are produced from this workflow.

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