Sponsor Role Section
SPIRIT 2025 item 3c calls for the role of the trial sponsor and funders in design, conduct, analysis, and reporting, including any authority they hold over those activities. The exact disclosure depends on the trial’s governance and contractual arrangements; do not infer independence or control that the protocol has not documented.
A Sponsor Role section states what the sponsor and funders do in the trial and what authority, if any, they have over design, conduct, analysis, interpretation, reporting, or publication decisions.
Key details
Important caveats
Scope Boundary
The exact disclosure depends on the trial’s governance and contractual arrangements; do not infer independence or control that the protocol has not documented.
Further guidance
Content
State relevant sponsor/funder responsibilities and authority across design, conduct, analysis, reporting, and related decisions, including when they have no role in a domain.
Purpose
Make sponsor and funder influence transparent so readers can distinguish funding from operational or decision-making control.
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.
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (opens in a new tab)BMJ / SPIRIT-CONSORT Group · Primary SPIRIT 2025 explanation and elaboration for trial protocols, including trial monitoring and data monitoring committee roles and reporting structure.