What information should I include in my COVID-19-related change of protocol?

Last update: 3.25.2020

In general, it is the same information as outlined here: What information should be included in new information reports about halts to study visits/procedures?. These changes should primarily focus on changes that have the potential to impact subject safety (changes in study drug administration, changes in the conduct of safety visits/activities, etc.). Note that any remote activities must be completed via one of the approved PHI exchange tools noted in guidance posted at the bottom of this page.

Keywords:coronavirus, changes, CP, COP   Doc ID:99455
Owner:Monica E.Group:Health Sciences IRBs
Created:2020-03-25 12:35 CDTUpdated:2020-03-25 12:35 CDT
Sites:Health Sciences IRBs
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