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Page: FDA Certificate of Confidentiality
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6 FDA Certificate of Confidentiality
calexh-sar edited this page 2021-04-29 08:04:19 -04:00
Table of Contents

Business Requirements

  • The IRB-HSR requires certain protocols collecting highly sensitive data to obtain a Certificate of Confidentiality (CoC) to protect the subjects. More information can be found on the FDA and UVA's IRB-HSR websites (search for FDA Certificate of Confidentiality).
  • The Coordinator will be able to upload a FDA Certificates of Confidentiality.

Protocol Builder Interface

This workflow relies on the presence of the Certificate of Confidentiality Application on the PB coversheet.

CRC1 Stats

This workflow does not have any CRC1 stats.

Study Dashboard Menu Dependencies

This workflow is part of the Coversheet Documents workflow and will be required if the Certificate of Confidentiality Application document is on the PB Coversheet.

Workflow Description

The workflow allows the Coordinator to upload one FDA Certificate of Confidentiality application.

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Generated Documents

No documents are generated from this workflow.

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