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.