Protocol and Statistical Analysis Plan Access Section
CONSORT 2025 includes an open-science item requiring reports to state where the trial protocol and statistical analysis plan can be accessed. This is access/reporting guidance, not a requirement to duplicate the full protocol or analysis plan inside the manuscript.
A Protocol and Statistical Analysis Plan Access section tells readers where the full protocol and statistical analysis plan are available.
Key details
Important caveats
Scope Boundary
This is access/reporting guidance, not a requirement to duplicate the full protocol or analysis plan inside the manuscript.
Further guidance
Content
Provide stable access information for the protocol and statistical analysis plan, such as registry, repository, journal supplement, or other persistent location, and distinguish versions when relevant.
Purpose
Give readers a direct, transparent route to the prespecified study documents used to understand and evaluate planned methods and analyses.
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.
- CONSORT 2025 statement: updated guideline for reporting randomised trials (opens in a new tab)BMJ / CONSORT Group · Primary 2025 CONSORT reporting guideline for randomized trials, including participant flow and trial-registration information.