Protocols - Review and Action Items

Reviewing a Protocol

Once an investigator has submitted a protocol for review the Protocol Administrator, assigned Reviewers, or Committee Members (if configured) can review all information and make necessary Action Items.  The protocols can be accessed from the Manage Protocols option in the menu by clicking on the linked Title of the protocol.  The Status of the protocol will indicate to the protocol administrator which protocols require review.

Upon opening the protocol you will have a number of review options to make assignments, add Action Items, set determinations, return to PI, etc. to process the protocol appropriately.  

Review Assignments

Review Assignments gives the option to add a specific Review Type, assign the protocol to a Committee and/or Meeting, and select a Review Deadline.  This is also where you can make Reviewer Assignments. In order for the Admin or Reviewer checklist to populate a protocol must be assigned to them via the Admin Review or Reviewer Assignments shown below.

Note: If a reviewer is listed on the protocol with a researcher role they cannot be assigned to review this protocol in the system.

Action Items

You can add a comment to a specific field via the Action Item links available throughout the submitted protocol form and this allows a back and forth conversation between the Administrators/Reviewers and the researchers preparing the protocol.

Once clicked it will open up a sidebar panel where you can enter your text and mark who has access to view the specific comment.

Visibility section allows you to select (highlight) the appropriate users that should have access to view the added Action Item.  If the user type is not added (highlighted) for a given comment it will not be visible to the user.  By default, and Administrator can see all action items unless they are also added as a researcher in the protocol.  A little more information on the visibility groups available:

• Assigned Reviewers - Any reviewer assigned to the protocol will be able to see the Action Item.
• Researchers - Any users with Researcher roles in the protocol will be able to view the Action Item.
• Meeting Summary - Defines whether Action Item will appear on a meeting agenda/minutes when you use the Agenda Summary option.  The action item is  nested under that view for the protocol that can be expanded.

NOTE: Only Admins will have visibility options; Committee Members that are assigned for review their comments will automatically default to 'admins only' and if the visibility settings need to be adjusted it would have to be done by an Admin after the review has been submitted.

You can also add a general review comments for the entire protocol via the Add General Comment button.

When the protocol is returned to the end user they can reply to the comment and you'll notice that the reviewer that made the original comment is marked as Anonymous; only Administrators can see the actual user that made the action item.

The back and forth conversation for a given Action Item can be expanded using the hide/show options so you can see the entire history.  Once an admin feels the issue has been addressed they can use the 'Mark as Resolved' option.

This will set the Action Item to Resolved but it can always be unchecked if further action is required.

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Track Changes

When the Show Latest Changes checkbox is selected it will display all changes to the protocol since the last version.  This allows Administrators a quick way to review what was changed by the investigator since the last review.  Items in red are removed text and green are added text.

Review Prior History or Activity

You can also use the Version dropdown to go back to see prior versions of the protocol if you wish to see the record in its entirety.

Also, the Activity Log allows you to view the history of actions that have occurred on this protocol since its inception, and can be accessed via the top bar of the protocol.

Review Actions

Protocol administrators will have the following action button available on the right-hand corner of the screen.

Displays a window allowing you to review all action item comments and replies for this protocol.

Notes and Files that can be added to the protocol by administrators that stay with the life of the protocol (and can be added at any point).

Action items for the protocol as a whole and not on a specific field.

This action button will approve the protocol. This option is not available if the Review Type is marked as Non Human Subjects Research.

This action button approves the protocol as Non Human Subjects Research. This option will only be available in IRB protocols once the Review Type is identified as Non Human Subjects Research.

This action will allow the admin to disapprove the protocol; once disapproved it cannot be undone or reused by the researcher.

This action button is reserved for the initiator so they can pull their protocol back for edit. If Action Items had been added and made visible to the researcher they could see those after withdraw.

Send the protocol back to the PI if it is incomplete and not ready for review; this opens up the entire protocol for edit like it's back in initiated status.

Review has been completed but further edits are required before it can be approved. This action allows you to record a decision date, and a deadline for the requested revisions.  Action items are also required before it can be returned so something specific is pointed out to the user for action/change.

Add the protocol to a committee, schedule, and mark the Review Type.

On a close request the Close button will be available and can be used to formally close out the protocol.

Allows you to view the entire protocol in PDF or print hardcopies if desired.