Event Adjudication Charter Guide

CHARTER GUIDE TABLE OF CONTENTS

APPROVAL PAGE

CONFIDENTIALITY STATEMENT

DESCRIPTION OF ROLES AND RESPONSIBILITIES

Clinical Investigational Site
The Investigator
The Site Coordinator
Sponsor
The Clinical Liaison
The Data Manager
The Statistical Programmer
The Endpoint Adjudication Coordinator
Adjudication Committee
Membership
Disbandment of the Committee
Study Participation of the Committee members
Meetings Conditions and Schedule
Conflict of Interest
Replacement of a Committee member
Documentation of the Committee work
Publications
The Chairperson
The Reviewers
Training of the Committee members

ENDPOINT STUDY INFORMATION

EVENT ADJUDICATION JUSTIFICATION

SCOPE OF THE ADJUDICATION

Clinical Events
Other cases
Use of the Outcome
Out of Scope

ENDPOINT ADJUDICATION SOFTWARE

ENDPOINT ADJUDICATION PROCESS

Timelines - Assessment of Workflow
Chart or schema of the Adjudication process
Event definitions
Definition of the events to be adjudicated
What data sources will be used to define the event?
Identification codes for anonymization of the events
Blinding provisions to clinical trial site and Sponsor
Management of patient’s identifiers and relation to allocation of treatment
Event Management
Methods for triggering the Adjudication process
Reviewers assignment rules
Preparation and transmission of the package
Adjudication forms
Events' Information Blinding and Translation
Management of Disagreements
Event Changed data
Status of Events
Adjudication Deliverables

QUALITY CONTROL: DATA SOURCES, PROCEDURES, ANALYSIS

Data sources
Procedure
Quality Control Mechanisms
Manual QC
Automated QC

APPENDICES

LIST OF ABBREVIATIONS AND ACRONYMS