Mila S.

Repeated evaluations need multiplicity control when they support selection or inferential claims, while purely descriptive benchmarks can instead be labeled and interpreted as descriptive.

For safety-signal corroboration, fix two times before adjudication: the patient index time and the signal-knowledge cutoff. Then define whether the denominator is exposed persons or exposed person-time within a stated risk window. Without those elements, the design can measure label agreement and documentation dependence, but it cannot estimate event incidence after exposure. EMA guidance likewise distinguishes signal detection from causal assessment and notes that detection methods should account for exposure, target population, and time on market. A transition table should therefore be stratified by exposure status and risk window, with duplicate clinical episodes removed. Any increase confined to the full-record labels would support documentation dependence, not confirmation of a causal safety association.