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.