Endpoint Adjudication: Assembling Medical Records in the Event's Dossier
The process adopted to assemble the Adjudication Packages by bundling all the documents, data or images required for a proper assessment is a crucial element of the Adjudication day by day management.
THE OPERATIONAL CONTEXT
The Adjudication Committee Members are blinded to the general trial data to avoid any external influence in their decisions but they need a clear picture of the Outcome to be Adjudicated.
In fact during the study when a potential endpoint is detected the Adjudication Staff must assemble a dossier by transferring all the relevant medical records from the trial databases in which they are collected to the Endpoint Adjudication Software environment.
These data management operations are carefully detailed in the Adjudication Charter and can be more or less complex depending on the information to be handled, on the number and location of the eClinical systems where these data are stored and also on the number of external service providers involved.
SIMPLE OR COMPLEX INTEGRATION LANDSCAPES
In the most advantageous landscape all the data required in the Adjudication Package are available in a single database like an EDC, a CTMS, an Adverse Event Database or a PACS Imaging System.
This scenario allows for a simple process that basically consists in formatting the info in a medium easy to be read by the Reviewers (e.g. PDF Case Report Summary) or in providing a tool (e.g Medical Images Viewer) for the assessments that require complex measurements.
Also the update / re-submission of the package in consequence of a change in the patient’s medical records can usually be handled without big issues.
This is a case well exploited by some providers of EDC, CTMS, Imaging System that are able to support Endpoint Adjudications simply adding to they general purpose software a new module to record the Reviewers’ assessments and to control the Adjudication workflow .
But when the Assessment requires a composite Event Package, made of documents, key variables, images, lab results that originate from different systems, likely managed by distinct subjects (e.g. Sponsor, CRO, Laboratory, etc), the job of the Adjudication Coordinators and Data Managers becomes much more complex.
eADJUDICATION SOFTWARE AS AN HUB OF DATA FLOWS
To easily manage these situations an Endpoint Adjudication Software must provide also sophisticated integration features and should be designed to streamline any integration scenario with the maximum of flexibility.
Technically it should configure as an Information Hub where different flows of data can converge, each one with its different structures, timelines and communication protocols.
Ethical eAdjudication can support three (3) different methods for assembling and updating the Medical Records needed for the Reviewers’ assessments. They can be combined and sequenced as needed to make the same Event Adjudication Package.
eADJUDICATION SOFTWARE FEATURES FOR EVENT PACKAGE BUILDING
1) Interactive upload of one of more documents (pdf, excel, txt, images, xml, etc) also zipped together and extracted once in the system;
2) Interactive data entry of key variables, narratives, etc, through web forms and edit checks (like EDC systems);
3) Automated Integration with the external source systems (EDC, CTMS, Adverse Event Databases, PACS Imaging System) implemented by using the Integration API and WebServices.
These API are included in the standard software provisioning and can be used for connecting external systems to the Adjudication database: to create new events, to add / update documents and variables and to alert the staff.
APIs can also be customised to receive data with proprietary structures (XML, CSV, Excel, SAS, etc.) and to merge the uploaded data/documents in a single narrative doc (PDF, TEXT).
Once an Event Package is created in the eAdjudication Repository it’s immediately available to the Staff.
They can review, modify and validate the Package for completeness (also through a Custom Event Template) before the actual submission/ re-submission to the Endpoint Committee.
AN ENDLESS NUMBER OF INTEGRATION CONFIGURATIONS
To give you an example among the endless number of data integration combination that the system is able to support:
1) you create & save an event in the repository;
2) then you add two Pdfs with a manual upload;
3) then you add some Key Variables using a customized web form;
4) then during the night a webservice adds an EGC Report coming from a trial site;
5) the system sends you an email alerting that a complete package is ready
6) Finally you check the event package and submit it to the Reviewers
Take present that any further step can be added, mixed or sorted as requested by the Adjudication Charter
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