Endpoint adjudication process record
====================================

StatMedAnalysis | Original downloadable worksheet | 6 November 2026

Make event classification reproducible and independent of avoidable bias.

How to use this worksheet
Define the endpoint criteria and evidence hierarchy before reviewing cases. Specify
reviewer training, blinding and disagreement resolution. Use synthetic cases to test
ambiguous boundaries. Track aggregate adjudication status and retain source locations in
the approved environment.

Save a working copy and keep the original blank version. Use public, hypothetical or
aggregate information only; do not enter patient identifiers, credentials or confidential
records. Keep source evidence in your approved project workspace. Mark unresolved text
fields UNKNOWN or NOT REPORTED with a reason; never substitute zero for an unknown count.

Project/version __________________  Prepared by role/date __________________

Working fields
1. Endpoint criteria/version
Response/evidence: _________________________________________________________
___________________________________________________________________________

2. Required evidence sources
Response/evidence: _________________________________________________________
___________________________________________________________________________

3. Reviewer roles and blinding
Response/evidence: _________________________________________________________
___________________________________________________________________________

4. Ambiguous-case examples
Response/evidence: _________________________________________________________
___________________________________________________________________________

5. Independent judgments
Response/evidence: _________________________________________________________
___________________________________________________________________________

6. Disagreement resolution rule
Response/evidence: _________________________________________________________
___________________________________________________________________________

7. Unresolved cases and deadlines
Response/evidence: _________________________________________________________
___________________________________________________________________________

8. Final classification audit
Response/evidence: _________________________________________________________
___________________________________________________________________________

Hypothetical worked case
A fictional possible event has a diagnosis code but no confirming test required by the
endpoint definition. Adjudicators mark it unresolved and seek evidence rather than
silently relaxing the criterion for one group.

Decision rule and limitations
Classify events according to the stated criteria and preserve uncertainty when evidence
is insufficient. Report adjudication procedures without implying that a review
eliminates all measurement error.

Decision _______________________  Remaining uncertainty ____________________
Next action ____________________  Owner / review date ______________________
Independent check and discrepancy resolution _______________________________

Official method or reporting reference checked 6 November 2026
https://www.consort-spirit.org/

This is an original planning aid, not an official checklist, validated instrument,
clinical recommendation or certificate of expert approval. Apply the referenced
guidance to the specific design and record any additional requirements.