During review (and after), you can complete the Add Comment activity to:
1. Post a note to the submission history that all individuals with access to the submission may view, and
2. 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.)
During review of a site (and after), you can complete the Correspond with Site or Correspond with sIRB activity, and:
1. Send a notice to any person associated with the study or site, including the other IRB office contact.
2. Include the text in the activity within the email sent to the recipient(s), and
3. While not preferred, if a person chooses to reply to this notice: you will receive replies to this notice in your email inbox, rather than posted on the submission workspace.
• 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.