Randomization Section
CONSORT 2025 requires randomized-trial reports to explain how the random allocation sequence was generated and the type of randomization, with enough detail to understand the allocation method. This guidance is specific to studies using random allocation. Observational or nonrandomized studies should not borrow randomization language for procedures they did not use.
A Randomization section explains how the random allocation sequence was generated and what randomization method was used.
Key details
Important caveats
Scope Boundary
This guidance is specific to studies using random allocation. Observational or nonrandomized studies should not borrow randomization language for procedures they did not use.
Further guidance
Content
Report the method used to generate the sequence and relevant restrictions; keep allocation concealment, implementation, and post-assignment blinding separate when the report distinguishes them.
Purpose
Make the sequence-generation method and any restriction such as blocking or stratification clear enough for readers to understand how random assignment was produced.
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.