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Event Adjudication Charter Guide

A guide for the creation and management of a Clinical Event Adjudication Charter

Event Adjudication charters are a key element for the setup of quality Adjudication procedures and have been developed in various formats. Ethical performed a thorough review of more than 20 endpoint adjudication charters in order to build its guide.

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TABLE OF CONTENT

  1. Approval page
  2. Confidentiality Statement
  3. Description of roles and responsibilities
    1. Clinical Investigational Site
      1. The Investigator
      2. The Site Coordinator
    2. Sponsor
      1. The Clinical Liaison
      2. The Data Manager
      3. The Statistical Programmer
      4. The Endpoint Adjudication Coordinator
    3. Adjudication Committee
      1. Membership
      2. Disbandment of the Committee
      3. Study Participation of the Committee members
      4. Meetings Conditions and Schedule
      5. Conflict of Interest
      6. Replacement of a Committee member
      7. Documentation of the Committee work
      8. Publications
      9. The Chairperson
      10. The Reviewers
      11. Training of the Committee members
  4. Study Information
  5. Adjudication Justification
  6. Scope of the Adjudication
    1. Clinical Events
    2. Other cases
    3. Use of the Outcome
    4. Out of Scope
  7. Endpoint Adjudication Software
  8. Endpoint Adjudication Process
    1. Timelines - Assessment of Workflow
    2. Chart or schema of the Adjudication process
    3. Event definitions
      1. Definition of the events to be adjudicated
      2. What data sources will be used to define the event?
      3. Identification codes for anonymization of the events
      4. Blinding provisions to clinical trial site and Sponsor
      5. Management of patient’s identifiers and relation to allocation of treatment
    4. Event Management
      1. Methods for triggering the Adjudication process
      2. Reviewers assignment rules
      3. Preparation and transmission of the package
      4. Adjudication forms
      5. Blinding and Translation
      6. Management of Disagreements
      7. Event Changed data
      8. Status of Events
    5. Adjudication Deliverables
  9. Quality Control: data sources, procedures, analysis
    1. Data sources
    2. Procedure
    3. Quality Control Mechanisms
      1. Manual QC
      2. Automated QC
  10. Appendices
  11. List of Abbreviations and Acronyms

 

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