Clinical Trial Endpoint Adjudication Software - Ethical eAdjudication ®

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Information about Clinical Trial Endpoint Adjudication Software - Ethical eAdjudication ®
Health & Medicine

Published on April 24, 2014

Author: ethicalgmbh

Source: slideshare.net

Description

Adjudication of Clinical Endpoints is growing together with the spread of clinical trials based on subjective evaluations like imaging and adaptive design and the aim of supporting quality assessments by a central commitee of independent experts.
These centralized evaluations of Clinical Events procedures are commonly implemented by sending to external experts some documentation about the clinical relevant events (event packages) and getting back their judgements in a blind way.

Ethical e Adjudication ® is a Service based on a Cloud Portal software designed to support Study Leaders, Committee Members and the Q.A. Staff across the adjudication process providing the right tools/services to accomplish their assignment in a timely, effective and quality controlled way.

SYSTEM REBRANDING to be customized with the Customer’s image of choice Ethical eAdjudication Clinical Endpoints Assessment Cloud Software summary of system interfaces Ethical eAdjudication – Clinical Endpoints Adjudication Software ver. 5.1 – info@ethical.ch – http://www.ethcial.ch

STUDIES MENU shows the Studies to which the authenticated user is mapped on ACCONT USERNAME system page footer shows the authenticated username together with the connection IP address SYSTEM SERVICES HelpDesk, User Account Profile, Log- Out

STUDY EVENTS REPOSITORY lists all the Events for the selected Study. The list can be sorted & filtered depending on event attributes or status. Shows different columns depending on User Profile EVENT DETAIL to access the Event Detail page for browsing or assessing the Event EVENT AUDIT TRAIL to access the Event Audit Trail with the complete Event history EVENT USERS to access the Event Users page with the list of Users associated with this Event

STUDY FUNCTION BUTTONS to access the Notifications, Exports (SAS), Reports system sections EVENTS LIST TOOLS to add an Event and to export the list in Pdf / Excel (csv) KEY VARIABLES STATUS FLAG it’s about any change in the Event Key Variables after submission DOCS STATUS FLAG alerts about any change in the Event Documentation after submission COORDINATOR DASHBOARD uses button color to highlight the presence of some Alerts to be reviewed by the Coordinator

EVENT DETAIL SECTION 1 shows the Event Key Variables current value and their Audit Trail EVENT DETAIL SECTION 2 shows the Event current documents and their versioning with access to all the versions available

EVENT DETAIL SECTION 3 the actual Assessment Form with custom fields, edit checks and workflows (also multiple pages) EVENT DETAIL SECTION 4 the Review’s Signature field to confirm the final assessment

EVENT AUDIT TRAIL the complete Audit Trail of an Event. Shows who, what, when, for every operation (export available) EVENT OPERATION DETAIL To access the Versioning of the Event Assessment Values

EVENT ASSIGNMENT TO REVIEWERS the complete history of an Event Submissions, Re-submissions and Assignement to Reviewers and Chairmen

COORDINATOR’S DASHBOARD ALERTS shows, when existing, system Alerts for special conditions like Events Never Submitted, Pending Assessments, Consensus Meeting queued for more than x days COORDINATOR’S DASHBOARD GAUGES they show Events figures and Event Status database composition COORDINATOR’S DASHBOARD ACTIONS they list Events for which an action is expected like More Data Requests and Consensus Meeting requests COORDINATOR’S DASHBOARD MONITORS the graphic of Pending Assessment distribution over the different Reviewers

REPORT CONSENSUS MEETINGS the graphic and table showing the distribution of Consensus Meeting Attendance over the Reviewers

REPORT MORE DATA REQUESTS the graphic and table showing the distribution of More Data Requests over the Reviewers

Thank you, for more information about the Ethical eAdjudication ® software, peculiarities & terminology please visit: http://www.ethical.ch Ethical eAdjudication – Clinical Endpoints Adjudication Software ver. 5.1 – info@ethical.ch – http://www.ethcial.ch

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