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08/01/2024 6:26 pm
Topic starter
When does your institution require data to be sequestered? Have you ever required it on exempt studies?
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17/01/2024 8:12 pm
Hi Lisa!
We would sequester data for directed audits or audits with findings that require additional verification. While we have not had to do that for Exempt studies, I can imagine a scenario where we would learn about study activities for an Exempt study that do not align with the IRB approved protocol, prompting us to do a deeper level of review.