Forum Rules:

  • Be courteous and respectful.
  • Ask questions and discuss topics of interest.
  • Share your knowledge and experiences.
  • Create connections and a sense of community.
Exempt Studies
 
Notifications
Clear all

Exempt Studies

1 Posts
2 Users
0 Reactions
215 Views
0
Topic starter

When does your institution require data to be sequestered? Have you ever required it on exempt studies?  

Topic Tags
1 Answer
0

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.

Share: