Summary

This article describes the usage of adjudication functionality within Fountayn.  

Table of Contents


Design | System

Adjudication refers to blinded evaluations of a clinical event, such as an image or adverse event interpretation, to determine whether they meet protocol definitions, and to provide standardized endpoint outcomes for the purposes of statistical analysis. Fountayn Adjudication functionality determines if the assessors have reached a consensus evaluation or if additional assessors are needed.

 

Introduction / Overview

This page describes the usage of adjudication functionality within Fountayn. Specific details of the workflows in your study can vary from the examples used below, depending on the needs of the study. The workflow described below is comprised of 5 steps:

  • Entry of data to be reviewed by adjudicators (examples: image data, adverse events, etc.), placing event into the adjudication workflow
  • Assignment of a ‘Facilitator’ who will manage the individual ‘Adjudicator’ assignments
  • Assignment of Adjudicators by the Facilitator
  • Independent entry of interpretation/evaluation data by each reviewer
  • Determination if consensus or a majority agreement (based on maximum required number of reviewers) is reached or if an additional reviewer is needed. Once majority or consensus has been reached on all compared questions, or once the maximum number of reviews is complete, the final outcome can be determined.

As each Facilitator or Reviewer is assigned, User Tasks will be added to the User Task Manager to track the progress of the work. See User Task Manager below for more information.

 

User View

Step 1: Initiating the Adjudication Workflow

In this example, Adverse Events are reviewed by Adjudicators who will assess Seriousness, Relation to Investigational Product, and more.

After the Adverse Event form is saved, a user in the designated role will indicate that the event is ready to be adjudicated by clicking the ‘Ready for Adjudication’ button.



This action creates an ‘Assignment’ form beneath the AE form, which will allow an enabled user, in this case one with the ‘Distributor’ role, to assign a Facilitator responsible for managing the Adjudicator assignments.

 

Step 2: Assignment of a Facilitator

The Distributor assigns the Facilitator by selecting a user from the available list of options. Typically, this question is configured to show a list of all users with access to the ‘Facilitator’ role for the study.



Upon saving this form, the minimum number of Adjudication forms are created (2, 3, or 4, depending on the configuration for the study). For example, in this study the maximum number of Adjudicators that will be used is 5 per adverse event. This means that 3 Adjudication forms will be initially created. Visibility of these forms will vary by role, based on the study configuration.

The assignment of a ‘Facilitator’ creates a User Task in the User Task Manager to track the progress of the work. See User Task Manager below for more information.

 

Step 3: Facilitator Assigns Adjudicators

The assigned Facilitator is then able to assign Adjudicators by selecting a name for each field. Similar to Facilitator assignment, these fields are typically configured to show a list of users with the ‘Adjudicator’ role for the study.

While the Facilitator may assign more than the minimum number of Adjudicators, the additional assignments will only be used if consensus is not reached by the initial reviewers.



The assignment of Adjudicators creates a User Task in the User Task Manager for each assignment to track the progress of the work. See User Task Manager below for more information.

 

Step 4: Adjudicator Assessment

Once assigned to a review, each Adjudicator can access the system and view only their own Assessment form, providing responses to the available questions. Based on the configuration, certain details from the event form may be displayed in order to assist with the review.



If discrepancies occur between the initial (minimum) number of Adjudicators, the system will trigger the creation of additional adjudicators as needed (up to the maximum) until the minimum level of agreement is reached. For example, for a 5-Adjudicator workflow, the minimum level of agreement is 3 (the majority). Therefore, if after the 3 initial reviews there are certain comparison questions without agreement, the system will determine the need for a fourth and possibly fifth adjudicator.

 

Step 5: Outcome Tracking and Determination

As each Adjudicator completes their assessment, an Outcome form (visibility based on configuration) will display the progress of the work.



If configured, a Status question will display a progress message indicating if all needed Adjudicators have been assigned, if initial assessments have been complete, if additional Adjudicators are needed, etc.

When the minimum level of agreement has not been met on any of the comparison questions, the system will indicate the need for additional Adjudicators (based on configuration).



In the image above, the initial 3 reviews did not produce agreement on all compared questions, therefore at least one additional adjudicator is needed.

Once the minimum level of agreement is reached on all questions, or when the maximum number of reviews is complete, the system provide preliminary results for each question being compared. When at least the minimum number of adjudicators agree on the same value, the value will be populated to this field. When less than the minimum number of adjudicators agree on a common value, the field will be left empty.

For each question being compared displays the results of the comparison across adjudicators as Consensus (agreement across all adjudicators), Majority (at least the minimum number of adjudicators, but not all, agreed on a value), or Dissent/Disagreement (no value was agreed to by the minimum amount of adjudicators).



In cases of ‘Dissent’, a Details question may be configured to show the answers selected by the various Adjudicators. The number in { } indicates the number of Adjudicators who provided the referenced response.

 

User Tasks Manager

When Adjudication functionality is in use, roles involved in the workflow may be given access to the User Tasks Manager. Based on configured permissions, a role may be able to see all User Tasks or only those assigned to them.

Manager Columns

This screen displays all Facilitation and Adjudication (Review) assignments as well as their status, with the following columns:

Owner

The system user assigned to the task.

Type

Displays the configured name of the task type. Although the displayed name may change from study to study, there are two primary task types – Facilitation (Adjudication assignment) and Adjudication (Review of data).

Status

Displays the current status of the task.

Disposer

Displays the name of the user who assigned the task.

Disposition Time

Displays the date and time of the last status update on the task.

Subject

Displays the subject’s primary and secondary identifier, with a link to the casebook.

Go To EDC

Displays a link directly to the Assignment form for the task.


 

Manager Filters

In addition to the filterable columns described above, the following additional filters are available:

Older than

Displays a list of available time filters to filter for tasks older than the specified increment of time. Note that time increments in Months and Years are approximate (30 days per month, 365 days per year).

Younger than

Displays a list of available time filters to filter for tasks younger (newer) than the specified increment of time. Note that time increments in Months and Years are approximate (30 days per month, 365 days per year).

 

User Tasks Email Notifications

Roles enabled with the ability to ‘Manage Notifications’ can configure email notifications to be sent to users upon assignment of Adjudication User Tasks.

 

Restart Adjudication

Within the workflow of adjudication, there is the possibility that the process will need to be restarted. For example, new data becomes available within the Adverse Event that is being adjudicated causing the previous adjudication to become invalid.

Based on the configuration of application properties and role permissions, a user with the appropriate role and on the applicable form can initiate the process from the ‘Actions’ menu.



Once ‘Restart Adjudication’ has been selected from the ‘Actions’ menu, the user will be directed to the ‘Restart Adjudication’ screen. The ‘Restart Adjudication’ screen will show a table of assessments that are complete in the adjudication workflow and a ‘Reason for Reopen’. An adjudication assessment and a ‘Reason for Reopen’ are required to proceed.

The available assessments to restart will depend on where ‘Restart Adjudication’ has been initiated from the ‘Actions’ menu.

  1. If ‘Restart Adjudication’ has been initiated from the Adjudicator Assignment form, the ‘Restart Adjudication’ screen will show all applicable Adjudicators who have a complete assessment.
  2. If ‘Restart Adjudication’ has been initiated from the individual Adjudicator Assessment form, the ‘Restart Adjudication’ screen will only show the Adjudicator applicable to that assessment as long as their assessment is complete.

‘Reopen Selected’ will direct the user to the ‘Confirm Adjudication Restart’ screen and ‘Cancel’ will direct the user back to the screen where the action was initiated.



If none of the adjudication assessments are complete, the user will be directed to the ‘Information’ screen and will display the following message based on the form where the action is initiated:

Adjudicator Assignment Form:



Adjudication Assessment Form:



Once an adjudication assessment has been chosen, a ‘Reason for Reopen’ has been provided, and ‘Reopen Selected’ has been selected, the user will be directed to the ‘Confirm Adjudication Restart’ screen.

‘Confirm’ will confirm the selections and ‘Cancel’ will direct the user back to the screen where the action was initiated.



Once ‘Confirm’ has been selected on the ‘Confirm Adjudication Restart’ screen, the user will be directed to the ‘Results of Restart’ adjudication screen.

‘Close’ will direct the user back to the screen where the action was initiated.



After the restart adjudication process has been completed the following will happen:

  1. The assessments that were restarted will have the assessment review status cleared. All other answered questions will be maintained.
  2. Each adjudicator who had their assessment restarted will receive an adjudication user task noting that the assessment was started but needs reviewed/completed.
  3. Adjudication outcome form will clear it’s evaluation of each adjudicated question.


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