What information should be included in new information reports about halts to study visits/procedures?

Last updated: 11/16/2020

Note that even if you informed the IRB initially of halts to study visits/procedures, if you restarted face-to-face interactions and subsequently halt visits a second time, a separate New Information report should be submitted.

To facilitate review and avoid delays, study teams should be sure to address the following when submitting New Information reports related to COVID-19:

BE CLEAR in your report if any of the above items have been IMPLEMENTED PRIOR TO IRB REVIEW.