FDA’s June 2026 conformance guide notes that there is no single standard or best practice for all adjudication data and directs sponsors to document where adjudication data reside and how adjudicated values can be distinguished from original values.
ReviewedEvidence1 sourceSectionWriting & Style
Quick answer
When a study includes adjudication data, document the chosen representation clearly and discuss the approach with the FDA review division when the current guidance calls for it.
Key details
Core IssueFDA’s June 2026 conformance guide notes that there is no single standard or best practice for all adjudication data and directs sponsors to document where adjudication data reside and how adjudicated values can be distinguished from original values.
Registerscholarly, professional, or research/report writing
Important caveats
Scope Boundary
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, and eCTD specifications before relying on version-sensitive requirements.
Further guidance
Content
This page covers submission representation and documentation, not the clinical methodology used to perform adjudication.
Purpose
When a study includes adjudication data, document the chosen representation clearly and discuss the approach with the FDA review division when the current guidance calls for it.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
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