Participant Timeline Section
SPIRIT 2025 requires a clear schedule of enrolment, interventions, and assessments so the timing of participant-facing trial events can be understood. The format and granularity should fit the design; a complex multi-period trial may need a figure or table, while a simple study may need less detail.
A Participant Timeline section or schedule shows when enrolment, allocation, interventions, follow-up, and outcome assessments occur for participants.
Key details
Important caveats
Scope Boundary
The format and granularity should fit the design; a complex multi-period trial may need a figure or table, while a simple study may need less detail.
Further guidance
Content
Present the major enrolment, intervention, and assessment time points in a concise timeline or schedule, with enough labels to connect them to the protocol methods.
Purpose
Give readers a time-ordered view of participant flow through the planned trial procedures.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- SPIRIT 2025 statement: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 reporting guideline for the minimum content of randomized-trial protocols, including amendments and protocol transparency.
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 explanation and elaboration for trial protocols, including trial monitoring and data monitoring committee roles and reporting structure.