Whether you need to adjudicate adverse events, patient eligibility or clinical outcomes; whether you plan to set up a large committee or enroll a single reviewer, and whatever your study therapeutic area or focus may be, you will need a comprehensive Adjudication Charter (AC). The AC takes time to develop, but it is worth the effort. Close up on a document that is key to the success of any adjudication process.
The Adjudication Charter is at the same time a guide, a contract and a protocol.
In a single document, all involved parties lay down the key elements for the adjudication process describing the role, scope and process followed by the Endpoint Adjudication Committee (EAC) or the Expert Medical Review Committee (EMRC) for endpoint or patient adjudication in any particular clinical trial. The AC may describe endpoints definitions, patient characteristics, data package composition, assignment methods, review process and periods, re-adjudication conditions, quality control methods, forms and all other elements of the adjudication process.
The EAC/EMRC members (as a minimum the chairperson) must participate to the authoring of the AC and all must sign the final document and receive appropriate training to ensure smooth running of the trial. The Adjudication Charter must at least contain the following sections:
1. Approval page
2. Study Abstract/Proposal/Introduction Page
3. Purpose of Adjudication
4. Scope of Adjudication
5. Adjudication Committee Membership
6. Adjudication Committee Training
7. Description of Endpoint Adjudication Software
8. Adjudication Process
9. Endpoint Assessment
10. Adjudication Deliverables
11. Communications
12. Timelines - Assessment of Workflow
13. Quality Control: data sources, procedures, analysis
14. Appendices
The quality and completeness of the Adjudication Charter is a defining factor for the overall quality of the clinical trial. The efforts you will put in your Adjudication Charter will be largely repaid.
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