Protocol Version Section
SPIRIT 2025 treats the protocol as a living document and emphasizes transparent version identification and an audit trail of dated changes. Version naming systems differ across organizations; the essential requirement is unambiguous identification and traceable amendments, not one mandatory numbering format.
A Protocol Version section identifies the current protocol version and date and supports a transparent record of amendments over the life of the trial.
Key details
Important caveats
Scope Boundary
Version naming systems differ across organizations; the essential requirement is unambiguous identification and traceable amendments, not one mandatory numbering format.
Further guidance
Content
State the protocol version identifier and date and maintain a dated description of important amendments or a clear link to the protocol’s change history.
Purpose
Let readers, ethics bodies, registries, and trial teams identify exactly which protocol version governs the reported methods.
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.