Data Sharing Section
CONSORT 2025 includes an open-science item on where and how de-identified participant-level data, statistical code, and other trial materials can be accessed. Data sharing must respect consent, privacy, ethics, legal, contractual, and repository requirements; do not promise unrestricted access when those constraints apply.
A Data Sharing section states whether and how de-identified participant-level data, code, and relevant materials will be made available.
Key details
Important caveats
Scope Boundary
Data sharing must respect consent, privacy, ethics, legal, contractual, and repository requirements; do not promise unrestricted access when those constraints apply.
Further guidance
Content
State what materials are available, where they can be accessed, any request or repository process, timing, conditions, and important restrictions where applicable.
Purpose
Make the availability conditions for reusable trial materials explicit rather than leaving readers to infer whether sharing is possible.
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.