Setting Up and Managing Adjudication
This article covers all topics related to adjudication, including how it’s configured and all steps of the workflow. Use the index to jump to the section relevant for your purposes.
Enabling Adjudication
Prerequisites
User has access to study configuration and form building
Before getting started with setting up adjudication, verify the function is enabled for the study as shown below.
Adjudication Roles and Permissions
Three primary roles are supported in the process of adjudicating an event form as described below.
Administrator – Configures the adjudication system using Role Security and the Form Builder.
Adjudicator – Votes on the result of an event. This is often one, two, or more Investigators.
Moderator – Manages the process and provide the final consensus on the causality of the event.
The three roles above will be discussed in this section. It is okay if your study does not have roles with the same names.
In order to set up Adjudication, the Adjudicator/Moderator permissions must first be assigned to the corresponding roles. This is done within the study's Role Security settings.
Adjudicator Role Example:
Note
Although a user role has the permission to adjudicate, it does not necessarily mean they will be doing so. Each user must be assigned to records as they are created in the study. This is covered below.
Moderator Role Example:
The Role That Will be Assigning Adjudication:
Defining Which Forms Will Be Adjudicated
Once the Moderator and Adjudicator roles are set, the Form Properties area of the Form Builder is where the adjudication is defined.
Note:
There must be at least one form that will be getting adjudicated, and at least one other form that is where the adjudication is captured.
1. First open the form that will need to be adjudicated/assessed. A common example is an Adverse Event form. In this example, the Adjudicator is the Investigator Role. The form should not be available for adjudication until it's been saved with no errors.
2. Next, open the form that the Adjudicator will be filling out.
3. Lastly, select the choice field(s) on the Adjudicator's form that will be used to measure or vote on causality. These are the field(s) that will be displayed during the moderation part of the process described below.
Managing Adjudication
Assigning Adjudicators
As events occur in the study and need to be adjudicated, a Study Manager or someone with permission to configure the adjudication must assign users to the events. This is done from the Study menu.
Your title goes here
User has access to Adjudication and the Configure Adjudication.
Web Browser | Mobile App |
|
|
.png "image(927).png")
Be sure there are users who have been assigned the adjudication role within the study. If no users are assigned to that role, this screen may get an error.
After opening the screen, On the web, If the section is not expanded already, tap the section header to expand it.
If more than one form is getting adjudicated in the study, it can be selected at the top of the screen.
The list of records are all forms which have met the status defined in the configuration.
Tap the Modify option on any record to change existing adjudicators or to assign new ones.
The list of users available to choose from are all users assigned to the role that is serving as the Adjudicator for the current selected form.
If an adjudicator is removed where adjudication has already been done, the status of the adjudicated record could change depending on it’s current status. For example, if it has already been adjudicator resolved, the record will update to pending adjudication.
Mobile App:
Users can be individually assigned to events simply by tapping and dragging them over to a record in the list on the right.
This is also where a manager can view who has been assigned to which events and who has completed review. This is done by tapping an existing record to see the assigned users in the list at the bottom.
.png "image(928).png")
Moderate (Resolve) Adjudicated Events
Prerequisite
User has access to Adjudication and the Moderator Report:
Once all assigned Adjudicators have performed their adjudication, the event can be finalized, or Moderated. This is like a final vote performed by a CEC committee.
When all Adjudicators have finished a given event, a notification is sent to Moderator users to inform them of the change in status so they know if any further action is required. Here’s an example of the notification:
Opening the Moderator Report
Available from the same screen as above under the Study menu on the web
First select the form that is being moderated (if there is more than one for the study). Then Expand the “Moderate Adjudication” section to see the status of all records
.gif)
Tip
Tap any of the Adjudicator name to open the Adjudicated form along with a PDF of that user’s adjudication
The status of records that are ready for moderation are:
A) Unresolved - 1 or more endpoints have different response from the Adjudicators
B) Adjudicator Resolved - All endpoints have matching responses
Other possible statuses displayed to Moderators are as follows, but cannot be moderated.
Awaiting assignments - No Adjudicators have been assigned
Pending adjudication - Adjudicators are assigned, but at least one has not yet performed the adjudication
Use the Moderate link on the right side of the table to perform moderation steps
The responses are shown in a table during Moderation where the Moderator can optionally indicate their own responses highlighted below. The columns and choices are dependent on the study configuration. This is essentially the same as a Moderator filling out their own adjudication form.
If the Moderator posts their own responses, the status will update to Moderator Resolved
Mobile App
Moderation is found under the Reports menu:
1. Select a form in the dropdown field at the top to see the existing records which are assigned to Adjudicators.
2. Records in the process of adjudication will be displayed in the top table. In the example above, the red icon indicates the record has not yet been moderated. This will be green after Moderating is done.
Tapping one will display which adjudicators have completed the process in the second table. Green=Completed by that adjudicator ; Red=Pending. Tapping those options then opens the record to view results directly.
3. Results on the primary adjudicated variable (choice field defined in the form builder), will display the votes made by each adjudicator. This prevents needing to open each record and view it manually.
In this example, we can see two adjudicators had different results. The CEC then makes a combined determination the bottom.
Moderating the form will set a flag to count it as moderated. That flag can be cleared with the same button.
Performing Adjudication
Adjudicators have simple access to any events which have been assigned to them, via the Adjudication Report found under the Reports menu on both the Web Browser and Mobile App.
Web Browser:
.png "image(931).png")
Mobile App:
On the next screen, use the filter at the top to select records that are Not yet adjudicated.
When filtering for records that have not yet been adjudicated, the list will only display records if the current user is assigned to perform adjudication on those records, and those records have met the status required to be adjudication-ready.
Open a form in the list to adjudicate it.
On the web browser, the adjudication form will automatically open a PDF version of the data being adjudicated, for the user to reference while they fill out the adjudication form. In this example, the Adjudicator gets directed to a form they need to fill out, while the Adverse event that is getting adjudicated opens up in a PDF in a separate window.
If the PDF does not automatically open, use the button shown here:
Note
You may need to allow popups in your browser for the PDF to open
After saving he Adjudication form, the status might still be “Pending Adjudication” if other assigned Adjudicators have not completed theirs. The system will automatically update the status as activities are completed as required.
Mobile App:
Mobile provides an advantage of both forms being visible on the same screen. The form to complete adjudication is at the bottom. The Save button at the top right will only save changes to the bottom (adjudication) form.
TIP
Tap and hold anywhere in the bottom panel to move the viewable area up or down
When finished, tap Save on the upper right. This will save the adjudication form.
Adjudication Report
Any user with access to moderate adjudication will be able to access the full report of Adjudication and Moderator responses.
This displays the data and can be exported.
Notice in this example, Event ID 63 was adjudicated be 2 users and its current status is Moderator Resolved because the Moderator also input responses to clear up a discrepancy that existed.
Note
The endpoints in this report are not using field labels because it’s a combined report. TrialKit can report on multiple adjudicated forms at one time. Endpoint #1 on one form might be different than endpoint #1 on another form. For example, if a study was adjudicating both Eligibility and adverse events.