Table A2.

Selected decision moments and governance adjustments across the three CAR cycles

CAR cycleDecision episodeNature of disagreementDecision authorityGovernance adjustment
Cycle 1Adoption of reference dataset (diabetology)Cross-specialty comparability and variable definitionsClinical leads (after interdisciplinary debate)Provisional shared CDM; formalized harmonization protocol
Cycle 2Introduction of synthetic data under FLClinical plausibility and regulatory legitimacyTechnical proposal with formal clinical approvalTSTR separation; unified real test set; retraining schedule
Cycle 3Institutionalization of clinical explanation roundsSufficiency of statistical metrics and SHAP explanations for accountable actionClinical validation authorityFormalized explanation rounds; retraining triggers; documented review process
Source(s): Authors own work

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