Protocols - Reportable Events

Overview

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 enabled by default in the protocols application but if you want to disable you can do that in the General Configuration of IRB Configuration, IACUC Configuration, and IBC Configuration.  Admins and Auditor roles will also have access to the Manage Events option in the left menu to help administer those requests.

Configuration

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.  

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 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 Admins for review.  It will also give you an optional comment section for the submit action and any added comments will display in the Researcher Communication section of Feedback at the top of the Reportable Event.
• 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.  This includes changes to the Event if it was returned and changes were made to fields - it will display the From and To values to see the before/after values.  For attachments that are removed or replaced you will see links to the attachment in the From and To so you still have access to the deleted or replaced attachments.
• View Protocol - Will take you to the protocol that the Reportable Event is associated.
• Print - Will open a separate browser window displaying the Reportable Event information that can be printed.

Reviewing Event

In Manage Protocols there are Event specific columns indicating if there are open/unresolved and are clickable:

As an Admin when reviewing a Reportable Event you have the below actions available:

• Submit Comment - To add a comment that is visible to the Researcher you can use the Submit Comment option (can be added by the end user or admin).  These comments will display in the Researcher Communication section of the Feedback at the top of the Reportable Event:
  
  
• 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. Please note, any person listed as personnel in the protocol will not be selectable as a Reviewer in the Reportable Event. 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 Admin is complete with their review and no further action is required on the Event they can resolve; 
• Not Reportable - If the 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.
• Add Review - To add a comment that is visible to the Admins and other Reviewers you can use the Add Review option (can be added by reviewers or admins).  These comments are not visible to the researchers.  These comments will display in the Reviewer Communication section of the Feedback at the top of the Reportable Event:
  
  
• Activity Log - Gives you a popup window that displays all actions and notifications for the specific Event.  This includes changes to the Event if it was returned and changes were made to fields - it will display the From and To values to see the before/after values.  For attachments that are removed or replaced you will see links to the attachment in the From and To so you still have access to the deleted or replaced attachments.
  
• View Protocol - Will take you to the protocol that the Reportable Event is associated.
• Print - Will open a separate browser window displaying the Reportable Event information that can be printed.

Events Assigned to Me

Once an 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.

• Add Review - When the review is complete the reviewer can use the Add Review action where they can add additional comments and submit.  The Reviewer comments will be visible to the other Reviewers and Admins only in the Feedback section.   Once the initial 'Add Review' is taken by the Reviewer the status of their review goes to Complete - but the reviewer can add additional comments to the Reviewer Communication via the Add Review button while the Reportable Event is still outstanding.
  
  
• Activity Log - Allows the reviewer to see all activity on the particular event. Will open a log of activities and notifications on the event.  This includes changes to the Event if it was returned and changes were made to fields - it will display the From and To values to see the before/after values.  For attachments that are removed or replaced you will see links to the attachment in the From and To so you still have access to the deleted or replaced attachments.
• View Protocol - Takes the reviewer to the protocol to review necessary information in the submitted/approved protocol.
• Print - Will open a separate browser window displaying the Reportable Event information that can be printed.

Meeting Integration

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.

Notifications

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, IACUC Configuration, and IBC Configuration articles.

Correspondence

Within the system configuration there is a correspondence specific to Reportable Events of 'Reportable Event Completed'.  When this is enabled it will allow you to generate/configure correspondence for when a Reportable Event is resolved.  Also, when this correspondence is enabled you will have the option to add a comment upon the Resolve action.  This comment can then be populated in the correspondence if you add the placeholder code 'Event Determination Comment'.  Once the correspondence is generated it will display in the Activity Log which is printable like other correspondence. More information on available Correspondence Templates can be found in the  IRB Configuration, IACUC Configuration, and IBC Configuration articles.