Protocol Amendments Section
SPIRIT 2025 describes the trial protocol as a living document and calls for transparent tracking of important protocol amendments so planned methods and later changes can be distinguished. Amendment-reporting duties vary by study type, ethics body, registry, regulator, funder, and journal. Follow the applicable requirements rather than inventing a universal format.
A Protocol Amendments section records important changes to an approved study protocol, including what changed, when, and why when that information is required or material.
Key details
Important caveats
Scope Boundary
Amendment-reporting duties vary by study type, ethics body, registry, regulator, funder, and journal. Follow the applicable requirements rather than inventing a universal format.
Further guidance
Content
Identify substantive amendments, dates or versions, and the reason or implications where required; keep minor editorial corrections separate from changes that affect trial conduct or interpretation.
Purpose
Preserve a transparent audit trail of material protocol changes so reviewers can distinguish the original plan from later revisions.
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.