During review (and after), you can complete the Add Comment activity to:
- Post a note to the submission history that all individuals with access to the submission may view, and
- If selected, send a notice to:
> PI/PI Proxy and Primary Contact
> Study Team Members and/or
> The assigned IRB Coordinator (If the IRB Coordinator box is selected and there is no assigned IRB Coordinator, a notice is sent to all members of the IRB office.)
• The information in the comment is visible to all individuals with access to the submission even if they are not selected as notice recipients.
• Do not attach items which are part of the regulatory review.
• If a submission is in the Clarifications Requested state, use the Submit Response activity to send information back to the IRB for continued review.