Adjudication Configuration and Administration
- TK Support
- TK Support
Adjudication allows several qualified individuals to decide causality with some entity. In TrialKit that entity is described on a case report form. TrialKit is set up to allow users with a certain role to vote to determine the outcome of some event.
As shown in the articles linked below, the app or web view allows adjudicators to view/adjudicate data in a single view on one screen.
Adjudication is role and user-driven. This means that you must have a certain role with the permissions to perform adjudication. Each user with that same role is a separate adjudicator. For example, a study can have a single Investigator role, but multiple users with that role will still be performing their own adjudication without visibility of the other user responses.
Read the following sections to set up and control Adjudication:
Enabling Adjudication
Verify the Adjudication option is enabled in Study Functionality:
Understanding Adjudication User Roles
Three primary roles are supported in the process of adjudicating an event form:
Administrator – Configure the Adjudication System using Role Security and the Form builder.
Adjudicator – Vote on the result of an event. This is often a couple of different Investigators
Moderator – Manage the process and provide the final consensus on the causality of the event.
The three roles above will be what is discussed in this section of the help. However, it's okay if your study does not necessarily have roles with the same titles.
In order to set up Adjudication, you must assign the Adjudicator/Moderator permissions to the roles in your study they will pertain to. To do this, navigate to Study Configuration -> Study Role-Based Security.
This allows you to add the Adjudication Report permission to the role of performing adjudication, and the same for the role doing the Moderating. Those roles should also be granted rights to the forms in which they need to adjudicate.
If a user role has the permission to adjudicate, it does not necessarily mean they will be doing so. As you will read in the next couple of articles, adjudication must be individually assigned to users as events require it.
The Administrator setting up the adjudication forms in the form builder will also need access to adjudication in order to configure the form properties.
Configuring Forms For Adjudication
Once the Moderator and Adjudicator roles are set, the Form Builder is where the adjudication is defined. From the Form Builder, open the form that will need adjudicating. A common example is an Adverse Event form.
Once the form is open, access the form properties and scroll down to the Adjudication section as highlighted below.
Web View
Four components are defined above:
If the form is going to be adjudicated, or if the current form is the one which the adjudicator will fill out.
The Roles responsible for adjudication and moderation
Adjudicate after which level - The status which a record must meet before the system allows it to be adjudicated
Adjudicator Form - If the current form is the one being adjudicated, which form will be the one the adjudicator fills out.
After setting the properties shown above, let's now take a look at the adjudication form which the adjudicator will fill out.
The final important step, and one that is easy to overlook, is defining which field on the adjudication form will serve as the final determining factor for the Moderator to use.
This is done by selecting one of the fields on the adjudication form and defining the field property shown below.
Please be sure to save all changes before exiting the form builder.
Assigning Adjudicators to Records
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, via the Configure Adjudication option highlighted below:
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 will produce an error.
Once open, users can be individually assigned to events simply by tapping and dragging. This is also where a manager can view who has been assigned to which events already and who has completed it.
Use the annotations to reference the detailed descriptions below the image.
Select the form to manage events for. Any number of forms in a study can be adjudicative based on what the Study Administrator has defined.
List of all users under the role which has been defined as the Adjudicator role for the form selected in item 1.
List of ALL events to date on the selected form. Unique record ID, Event name, event date, site, and subject ID are all displayed.
For the event selected in Item 3, a list of currently assigned users will display. Green means the user has completed their adjudication. Red means it is still awaiting.
Read here about how adjudication is performed by individual users.
Moderating Adjudication - CEC
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.
This is done via the Moderate report under the Reports menu:
Records in the process of adjudication will be displayed in the top table. Tapping one will display which adjudicators have completed the process in the second table. Tapping those options then opens the record to view results directly.
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.
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