Should I submit a New Information report or a Change of Protocol for my COVID-19-related protocol updates?
Last updated: 3.25.2020
Halts to in-person study activities/visits should be reported to the IRB, as outlined here: What information should be included in new information reports about halts to study visits/procedures?. For most minimal risk studies, these halts to in-person study activities do not require additional action to mitigate effects on subject safety. For potentially therapeutic studies that have currently enrolled subjects, however, the continued conduct of the study may require significant changes to procedures in order to continue to monitor subject safety, provide study drug, or collect critical data. In these situations, a change of protocol should be submitted, rather than a New Information report.