The Reportable Events functionality in Protocols allows a user to disclose events that occurred within a project that diverged from the approved protocol and requires additional review and approval. Once submitted the admins can review and take the necessary actions on the event. This functionality is not enabled by default in the protocols application so if you are interested please submit a support request and we can enable in your SBX environment for testing and setup before applying to your PRD. A future configuration in the frontend to enable this functionality in forthcoming.
The Event functionality has an associated template where you can configure the information gathered in an event submission. There is a default template out of the box but it can be configured as needed to meet your institutional needs. More information on using templates can be found in the Protocols - Templates article.
A future configuration in the frontend to enable/disable Reportable Events functionality in forthcoming.
Creating an Event
Within the protocol along the top header you will notice the Reportable Event option where all prior events can be managed, viewed, searched, and new events created.
The Report an Event button will create a new event entry to submit for review by the COI Admin.
The Event form is dependent on the Event Template you've created in the Templates option in Configuration.
Within the the new Event the user has the following action buttons:
- Save - Will save edits to the event; there is no automatic saving in Reportable Events so this save button must be used to retain changes.
- Submit for Review - Will submit the event to COI Admins for review.
- Delete - When the event is initiated (but not yet submitted) you can delete if you don't want to proceed with creation.
- Activity Log - Will open a log of activities and notifications on the event.
In Manage Protocols there are Event specific columns indicating if there are open/unresolved and are clickable:
When reviewing a Reportable Event you have the below actions available:
- Review Assignments - Similar to assignments in normal protocol actions you can assign an Event to a specific Review Type, Committee, Admin, and Meeting for review and also assign specific Reviewers associated with those committees. More information on the review actions is below in Events Assigned to Me section and general If it is assigned to a specific meeting it will also show up in the corresponding agenda for the meeting.
- Require Follow Up - If you need additional information you can do the Require Follow which allows you to send back the Event with additional comments and a reason for Followup. Once the submitter addresses the comments they can submit for review again.
- Resolve - If the COI Admin is complete with their review and no further action is required on the Event they can resolve;
- Not Reportable - If the COI Admin completes their review and determines the event doesn't warrant a reportable event action they can use the Not Reportable action to classify the submission; the non-reportable event will still show in the history of the Protocol.
- Activity Log - Gives you a popup window that displays all actions and notifications for the specific Event.
Events Assigned to Me
Once a COI Admin assigns a Reportable Event to a reviewer then the Event will be displayed for these users in the Events Assigned to Me menu.
All Events assigned to the user for review will display in this section and upon opening they can review the Event and associated protocol as needed before making their assessment and submitting their review. The below action buttons are available for reviewers.
- Submit Review - When the review is complete the reviewer can use the Submit Review action where they can add additional comments and submit. The Reviewer comments will be visible to the COI Admins in the Feedback section prior to Resolution.
- Activity Log - Allows the reviewer to see all activity on the particular event.
- View Protocol - Takes the reviewer to the protocol to review necessary information in the submitted/approved protocol.
If a Reportable Event is assigned to a Committee/Meeting the event will also display in the Agenda of the meeting so it can be discussed along with other protocols for review. Within the Reportable Events section you will see the assigned Event with the protocol number and current status; the event description will also link directly to the Event for review.
Within the system configuration there are notifications specific to Reportable Events that can be configured to send with desired text and recipients. Sent notifications will also show in the Activity Log for the Event. More information on how to edit Notifications can be found in the IRB Configuration and IACUC Configuration articles.