The Adjudication Charter is the fundamental document describing the Endpoint Adjudication procedure to be applied in a specific Clinical Trial. In this article we list the topics to be considered as “key” content of a standard Adjudication Charter.
Adjudication Charter Introduction
- Study abstract - Adjudication rationale
Description of the Clinical Trial, Study objectives (primary, secondary, exploratory, safety) and the rationale for adjudicating endpoints.
Clinical Endpoint Committee (CEC)
- Adjudication roles definitions: Sponsor, Contractors, Chairman, Reviewers (clinicians), Coordinator, Support Personnel
Identification and definition of all the roles involved in the Adjudication process. In particular reference to the Clinical Events Committee composition and Members requested curricula. Special attention should be given to the CEC Chairman and Coordinators due to their key role in the process.
Endpoint Events
- Endpoint definitions - identification criteria
Description and definitions of what constitutes an Endpoint, methods of endpoint identification, classification in primary / secondary - Events sources - delivery to assessment procedures
Description of Events detection sources and the procedure to be followed for delivering a potential endpoint to the CEC for assessment. Event identification codes for making the events anonymous (blinding). - Event Package composition - Documents & key data
Description of the required contents of an Event Package. List of source documents, key values / variables, database from where this information is to be collected and related procedures. Description of tools available to Reviewers for browsing, visualizing and comparing this information.
Endpoints Assessments
- Event submission - Assignment to reviewers
Description of the event submission procedure and rules applied for assignment to a specific Reviewer from the available pool of CEC Members. - Assessment workflow - timelines
Description and flowchart of the Endpoint Assessment Standard Procedures and Workflows, Submission and Assessment timelines, description of the software possibly used to support Adjudication procedures (eAdjudication®). - Forms (structure - edit checks - workflow)
Description of the Forms used to collect the Assessment from the Reviewers, list of the Data Edit Checks, filling instructions and user interface behavior of the eAdjudication software online forms. - "More Data" requests - more data collection procedures
Description of procedure available to Reviewers to ask for additional information or for clarification of information included in the Event Package. Additional data collection procedures and description of the notifications to Reviewer for availability or unavailability of "More Data". - Disagreement management - classification
Description of the procedures to handle Disagreements among Reviewers. Classification of disagreement (Major or Minor Disagreements) and respective resolution procedures. - Consensus Meeting composition - Consensus Meeting procedures - Consensus Meeting assessment
Consensus Meeting (the panel appointed to the final assessment decision in case of Committee Members' disagreement) member composition, consensus assessment procedures and delivery. - Event Changed Data - Event Resubmission
Description of procedures to handle substantial changes in the Event information after submission (follow-up). Notifications to Committee Members. Event re-submission process. - Communications: contact info, communications triggers and formats
List of people involved in the process with respective role, responsibility and contact info. Description of the situations that should trigger a communication among staff and Committee Members, communication templates. - Adjudication Deliverables: assessment structure, adjudication reporting, data exports SAS/XML, submission documents structure
Description of the formal structure of the Assessments. Deliverables to be submitted to Regulatory Authorities. Reporting, Data & Metadata Exports. - Quality Control: data sources, procedures, analysis
Description of Quality Control procedures and corrective measures workflows.
DOWNLOAD NOW THE ENDPOINT ADJUDICATION HANDBOOK
The Complete Manual / Reference Book with all the topics related to the Independent Endpoint Adjudication Committees Management
