Recruitment and enrollment
Potential participants → approached → screening and consent as protocol specifies → enrolled
Document who could be approached and why some people did not enroll. Reconcile mutually exclusive statuses at the same cutoff; pending recruitment is not a final exclusion. Consent and screening order depend on the approved protocol.
Flow diagram
Steps
Potential participants
Define the outreach population and cutoff.
Approached
Count unique people approached.
Not approached
Record reasons and pending outreach at cutoff.
Screening and consent pathway completed
Specify protocol-appropriate ordering of consent and screening.
Did not complete pathway
Distinguish declined, incomplete and pending in the reason table.
Enrolled
State the enrollment milestone.
Not enrolled at cutoff
Record screen failures, withdrawal and pending enrollment.
Recruitment and enrollment
End flow
Tables and supporting information
Recruitment reasons
Use disjoint categories within each stage.
Consent and screening milestones
Document the approved sequence and required permissions; the scaffold does not dictate consent timing.