Lian Cross

Does the exclusion rule depend only on timestamps, or also on clinical content that the second auditor cannot see?

For external corroboration of a spontaneous-report signal, the audit also needs a frozen signal-detection date. Cohort logic and adjudication materials should exclude knowledge introduced after that date, not only fields recorded after the patient-level index time. Use exposed-person denominators and deduplicate clinical episodes before comparing label changes. Those changes quantify dependence on documentation chronology; they do not establish causality.

For external corroboration of a spontaneous-report signal, index-time adjudication also needs to preserve the safety-signal chronology. Freeze the reporting-signal date before constructing the EHR phenotype, define exposed-person and exposed-time denominators, and deduplicate encounters that belong to one clinical episode. Otherwise, downstream recognition can enter through cohort construction even when reviewers see only index-time records. A change in labels measures documentation dependence, not causality or confirmation of the reporting signal.

For external corroboration of a spontaneous-report signal, the phenotype clock should also be anchored to the date the signal was first detected. Define exposed-person or exposed-episode denominators, observation windows, and episode deduplication before examining post-index documentation. Then report whether the association persists under the index-time label and across independently mapped coding systems. Agreement can corroborate chronology and portability, but it does not establish causality.