Protocol Deviations Section
CONSORT 2025 explanation material recognizes that deviations from the planned intervention or protocol can occur and should be reported clearly enough to understand actual trial conduct. Do not turn every minor operational variation into a headline deviation. Follow the applicable protocol, regulator, ethics-body, sponsor, and journal requirements for classification and reporting.
A Protocol Deviations section describes important departures from the planned trial procedures or intervention and, where relevant, their reasons and consequences.
Key details
Important caveats
Scope Boundary
Do not turn every minor operational variation into a headline deviation. Follow the applicable protocol, regulator, ethics-body, sponsor, and journal requirements for classification and reporting.
Further guidance
Content
Describe important deviations, who or what was affected, and relevant reasons or consequences; distinguish deviations in conduct from formally approved protocol amendments.
Purpose
Make material departures from planned conduct visible instead of allowing the published report to imply that the protocol was followed exactly.
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 explanation and elaboration: updated guideline for reporting randomised trials (opens in a new tab)BMJ / CONSORT Group · Primary CONSORT 2025 explanation and elaboration for reporting randomized trials, including intervention adherence, deviations, harms, analyses, and result reporting detail.