Quick guide for reviewers

Protocol form navigation

When a protocol is opened, top navigation tabs appear on the screen and include: Protocol, Reportable Events, Activity Log, and My Checklist.  The Protocol screen contains a left sectional navigation menu to jump to sections within the form.  The right menu contains action buttons, including Submit for Review.

Review a new or renewal/amendment submission

1. Scroll through the protocol form or use sectional navigation to view the entire protocol application.
2. Review and Post Action items 
   1. All fields in the protocol have a +Action Item button to the right of the field.  Committee Action Items are always anonymous and not visible to researcher unless given express permission by the administrator.
   2. As you review the protocol, post any additional comments or requested changes by clicking the +Action Item button to the right of field you expect to be addressed and click the Post button at the bottom of the Action Item.
   3. Previously posted action items are identified with a numbered circle both in left navigation and next to the action item button.  Clicking on the button opens the action item menu on the right of the screen.  If asked to respond to an action item, select +Action Item to post a response and click the Post button at the bottom of the Action Item. Click the arrow on the top right of the posted Action Item to close the Action Item menu.
   4. If you would like to leave a comment pertaining to the whole protocol, or to an entire section of the protocol, use the General Action Items link in menu on the right of the screen.
   5. When reviewing changes after resubmission, check the Compare Versions box at the top of the screen to see tracked changes throughout the protocol form. 

Complete your review checklist

1. Click My Checklist in top form navigation.
2. Complete the fields in your checklist. If you have recommended provisional approval or to table the submission, click Save. If you have recommended the protocol be approved or disapproved, click Save and click Mark As Complete in the right-hand menu.  If you have not recommended the protocol be approved or disapproved, you are prevented from marking as complete and will click Save.

Submit your review

Once you have added/responded to all action items and completed your checklist

1. Click Protocol in top form navigation.
2. Click Submit Review in the right-hand menu.

1. Navigate to the Protocols Assigned to Me screen to view a list of protocol submissions assigned for your review.
2. Click on the protocol title to open the protocol for review.
3. Click on Ancillary Review at the top of the screen, expand the Ancillary Review item to review Administrator comments, instructions, or attachments.
4. Click on Protocol at the top of the screen, use the left-hand section navigation, or scroll through the protocol form to view the sections relative to your review.
5. Click on Add Comment and add a comment as the Ancillary Reviewer, and/or add a relevant attachment, then press Post.
6. Click on Ancillary Review at the top of the screen and expand the Ancillary Review to add review comments or request additional information. 
7. Change the status of the Ancillary Review by clicking on the up/down arrows and select either:
   1. Approved. This alerts the primary administrator that the ancillary review is complete, or
   2. Not Approved Yet.  This indicates additional information is required.  The primary administrator will relay concerns to the research team and respond to your comments to address issues or concerns. Repeat this process until your ancillary review is complete and Approved is selected.
8. Expand the Ancillary Review again and check that the date and time of the status change was documented in a System Generated comment.
9. Once approved, the Ancillary Review tab at the top of the screen has a green marker.
10. Click on Activity Log and confirm that the Ancillary Status Changed action displays at the bottom of the list.