Follow-up and safety

Plan assessments monitoring and disposition

Stopping treatment need not end outcome follow-up. Distinguish adverse-event seriousness from severity, define ascertainment windows and keep clinical safety review separate from statistical efficacy monitoring.

Flow diagram

Steps

Define baseline and assessment schedule

Specify visits, outcome windows and responsibilities.

Conduct follow-up

Plan retention, adherence and missed-visit handling.

Define safety collection and reporting

Define adverse-event ascertainment, seriousness, severity, relatedness and reporting windows. Seriousness and severity are different attributes; retain relevant follow-up after treatment discontinuation.

Specify monitoring and escalation

Define authorized reviewers, data access, triggers and decision responsibilities.

Specify stopping or early closure rules

Separate participant-level stopping from trial-level safety, futility or efficacy decisions.

Document disposition and completion

Distinguish treatment discontinuation from withdrawal from outcome follow-up.