Judi: Advanced Features for Endpoint Adjudication


Site Source Document Management

Source documents are at the core of every endpoint adjudication process. A study coordinator at the site is tasked with gathering these documents which vary depending on the type of event being adjudicated. Those that aren’t medical images are typically scanned from their paper form, and must be catalogued and deidentified prior to submission to a CRO for dossier creation. Judi provides advanced functionality that greatly facilitates this task for sites, reducing opportunities to introduce errors in the process. Two of these features are worth noting:

  1. Document Splitting: With Judi, a study coordinator can upload all the necessary documents as a single PDF file, and is not required to scan and upload each document separately. Once this quick process completes, the study coordinator is provided with an intuitive facility to split the file into multiple files by picking one or more pages and moving them to the appropriate category. This not only saves time for the investigator site, but enables them to quickly and efficiently fulfill the source document requirements for an effective endpoint adjudication process.
  2. Deidentification: Anonymizing source documents to eliminate the presence of personal health information (PHI) is an integral part of every clinical trial. Judi provides a study coordinator an advanced facility to easily and securely redact all PHI from the source documents they submit. Through the Judi deidentification feature, a user simply highlights the text or the area in the document that has this information, and Judi automatically and permanently redacts the content before it leaves the investigator site. Should an occurrence of PHI escape the sender’s process, a trial coordinator at the CRO can further deidentify any missed instances.

Medical Images as Source Documents

Medical images represent a completely different type of source document. Medical images in an adjudication process may hold the key to understanding a specific case. Unfortunately, due to the relative size and complexity of images, this data is most often managed in an external workflow from the rest of the event-related data. Judi changes this. Judi has a unique capability to handle these complex and large datasets. When DICOM images need to be part of an adjudicator’s dossier for a particular event, Judi enables the user to treat them in a similar manner as any other source document. Judi adds an integrated facility to upload, deidentify, quality check, submit and store imaging exams so they can be included in the endpoint adjudication package. From there, AG Mednet’s integrated cloud storage enables the client to include them in the dossier. Judi enables adjudicators to view these exams in an integrated, full-featured viewer for analysis. In those cases where the entire endpoint adjudication process revolves around the collection, storage, quality control and viewing of DICOM exams, Judi enables advanced workflows that implement the processes of an imaging core lab, regardless of complexity. Users are able to view the exams from within Judi as they would any other source data.

Event Triggers and Preferred Term Workflows

At AG Mednet we understand that adverse events (AEs) are triggered in a variety of ways, including by a safety system or an EDC. In addition to that, there are times when AEs need to be triggered by trial teams scanning for preferred terms (PT events) in their various project databases. Whether triggered automatically by an upstream system, or manually by a trial team, Judi provides the functionality necessary to manage the event from beginning to end, while keeping track of its origin as well as the full path it follows through the process until final endpoint adjudication. Specialized PT event workflows are native to Judi and highly configurable. When an endpoint adjudication management team detects what may constitute an AE, this event can be created in Judi and the PT workflow carries it forward to the person who will determine whether it is in fact an AE. Configurable eCRFs can be presented and depending on the entries the process could be stopped, moved to a committee for determination of whether it constitutes an AE, or proceed directly into the standard event type workflow for full adjudication. All actions and state transitions are logged in all cases and tailored reports generated as needed.

CDISC Control and Ad Hoc Dictionary per Form Element

When looking at an endpoint adjudication process, different constituencies have distinct perspectives. For example, while the fields in any particular eCRF should be very descriptive to help a user fill in the correct information, it is often desirable to present the same data in a different way to someone else or to another system. Judi has an internal, configurable dictionary for these different representations to exist concurrently. These could include a long descriptive one for users, a short one for column headings in a report, a single value for an internal system and the CDISC equivalent for export. We have significantly increased data accuracy and reduced error rates caused by not relying on eCRF text or report formatting for this activity.

Duplicate Event Management

Event adjudication processes are complex because of the number of moving parts that all need to come together to enable the right decision to be made. At the same time, the statistics provided by the occurrence of AEs inform the effectiveness and efficacy of a drug or device, and therefore adjudicated events must reflect reality as closely as possible. When managing event adjudication in clinical trials it is possible that single events might be triggered more than once for one subject, and not being recognized as such, can create two instances when only one actually occurred. Judi has implemented advanced functionality to reduce and eliminate multiple adjudication of duplicate events. One way in which this advanced feature can be configured is to present adjudicators with duplicate event candidates when they receive the dossier and the associated eCRF. The electronic form can present other events for the same subject based on a configurable time frame or other criteria, whether they have been adjudicated already or whether they are in the process. If the event in question is in fact a duplicate, it can be linked to the existing one and no additional adjudication needs to take place.

Event Gating and Linkage

There are times in complex adjudication processes when it is desirable to gate multiple events for a single subject. For example, perhaps a death event has been reported and is flowing through the system. Two other events for that subject are subsequently triggered, an MI and a stroke. If the specific trial finds it desirable, Judi can be configured to detect these additional AEs for the same subject and move them ahead of the death event in the endpoint adjudication workflow. Adjudicators can then determine the cause of each AE and is able to link them, creating a more complete picture of what transpired for this specific subject. In general terms, Judi can be configured to hold any event type in any state based on specific endpoint adjudication workflow design requirements.