Endpoint Adjudication: Assembling Patient's Medical Records in the Event Package

CLINICAL ENDPOINT ADJUDICATIONAssembling Patient’s Medical Recordsin the Event Package for Adjudication

Ethical GmbH - [email protected] - www.ethical.ch 1

THE REVIEWERS NEED AN INFO PACKAGE

Adjudication Committee Membersare blinded to the trial data and Protocol

to avoid any external influenceor bias in their decisions.

But to express their Assessment theyneed instead a clear picture

of the Outcome to be Adjudicated


In fact when a potential endpoint is detected

a dossier must be assembled by transferring all

the relevant medical records from the trial

databases in which they are collected to the

Endpoint Adjudication Software environment


THE ENDPOINT ADJUDICATION PACKAGE

DATA MANAGEMENT IN ADJUDICATIONS

These data management operations must be carefully detailed in the Adjudication Charter

They can be more or less complex depending on the data required, on the number and location of

the Source Systems and also on the number of external Service Providers involved.


SINGLE SOURCE FOR MEDICAL RECORDS

In the most advantageous landscape all the information 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 basically consists in formatting the data in a medium easy to be read by the

Reviewers (e.g. PDF Case Report Summary) or in providing a Viewer Tool (e.g Medical Images).

Also the update / re-submission of the package following a change in the patient’s medical records

can usually be handled without big issues.


SINGLE SOURCE FOR MEDICAL RECORDS

MULTIPLE SOURCE FOR MEDICAL RECORDS

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 work of the Adjudication Coordinators and Data Managers becomes much more complex.


ADJUDICATION EVENT REPOSITORY

technically in these cases theAdjudication Events’ Repository

must be configured as an

Information Hub

with different flows of data that must converge, each one with its different structures,

timelines and communication protocols.Ethical GmbH - [email protected] - www.ethical.ch 8

3 WAYS FOR GETTING IN MEDICAL RECORDS

Ethical eAdjudication supports three (3) different methods for assembling and

updating the Medical Recordsin the Event Package.

And they can be combined and sequencedas needed to build /update the same

Event Adjudication Package.


1) THROUGH SIMPLE UPLOADS

Interactive upload to the Cloud of one of more documents (e.g. pdf, excel, txt, images, xml, etc)


that can be zipped togetherand extracted once in the eAdjudication ® system

2) THROUGH INTERACTIVE DATA ENTRY

Interactive Data Entry of key variablesor narratives through System Web Forms


with custom Edit Checksas in Electronic Data Capture

3) THROUGH INTEGRATION

direct Data Integration with the external source systems (EDC, CTMS, Adverse Event Databases, PACS) using the eAdjudication®

Integration API and WebServices

to create new events, to add/update documents and key variables


VALIDATION BEFORESUBMISSION TO REVIEWERS

Once an Event Package is created in the eAdjudication Repository it’simmediately available to the Staff.

It can be reviewed, modified and validated for completeness (also through a Custom Event Template) before the actual submission/re-

submission to the Endpoint Committee.


eAdjudication® Cloud servicefor more Information & free demo: www.ethical.ch


Date post:	20-Jul-2015
Category:	Health & Medicine
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Endpoint Adjudication: Assembling Patient's Medical Records in the Event Package

Health & Medicine