Recruitment and treatment
Track enrollment and intervention receipt
Retain screening, enrollment and intervention receipt as distinct statuses. Participants not treated or discontinuing early still matter for the prespecified study population and safety accounting.
Flow diagram
Steps
Screen candidates
Specify eligibility, recruitment channels and screening permissions.
Consent and enroll
Record informed consent and enrolled population.
Deliver study intervention
Specify regimen, adherence and treatment receipt.
Record deviations and discontinuation
Preserve enrolled versus treated populations.
Continue outcome and safety follow-up
Document withdrawal from treatment separately from follow-up.
Recruitment and treatment
End flow
Tables and supporting information
Intervention delivery
Leave study regimen and quantities blank.