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.
Practical Application
State what can be shared—such as de-identified participant-level data, statistical code, or supporting materials—where it can be accessed, when it becomes available, and any request, repository, consent, privacy, legal, contractual, or ethical conditions. Do not promise unrestricted access when the study cannot lawfully or ethically provide it.
Purpose
Make the availability conditions for reusable trial materials explicit rather than leaving readers to infer whether sharing is possible.
Reader Check
Can a reader tell exactly what is available, where to obtain it, when access begins, and which restrictions or approval steps apply?
Worked Example
A useful statement might distinguish a public analysis-code repository from participant-level data that require a controlled request and data-use agreement, rather than saying only “data available on request.”
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.