From 1d60837cfe99aaef9c2351d7b39003294749bf06 Mon Sep 17 00:00:00 2001 From: calexh-sar <54854669+calexh-sar@users.noreply.github.com> Date: Fri, 2 Apr 2021 15:12:50 -0400 Subject: [PATCH] Updated FDA Certificate of Confidentiality (markdown) --- FDA-Certificate-of-Confidentiality.md | 24 +++++++++++++++++++++++- 1 file changed, 23 insertions(+), 1 deletion(-) diff --git a/FDA-Certificate-of-Confidentiality.md b/FDA-Certificate-of-Confidentiality.md index fdf702f..90079f3 100644 --- a/FDA-Certificate-of-Confidentiality.md +++ b/FDA-Certificate-of-Confidentiality.md @@ -1 +1,23 @@ -Coming soon... \ No newline at end of file +### 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](https://www.fda.gov/) and [UVA's IRB-HSR](http://www.virginia.edu/vpr/irb/hsr/) websites (_search for FDA Certificate of Confidentiality_). +- The Coordinator will be able to upload one or more 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 +| State | Condition | +|:--------:|:---------:| +| required | _Certificate of Confidentiality Application_ document on PB Coversheet | +| hidden | _Certificate of Confidentiality Application_ document not on PB Coversheet | + +### Workflow Description + + +![image.png](https://images.zenhubusercontent.com/5f0623d8a1d620a9f39301dc/ff275dc4-dabd-4b92-a220-ff498dbb975e) + +### Documents +No documents are produced from this workflow. \ No newline at end of file