2025 SPIRIT Statement (Standard Protocol items)

2025
  • Research question
  • Develop a protocol
  • Foundational design
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SPIRIT–CONSORT is a set of internationally recognized reporting resources for interventional trials, supporting both trial protocol development and randomized trial reporting. The SPIRIT–CONSORT website brings together two complementary guideline families for randomized controlled trials—SPIRIT 2025 for protocol reporting and CONSORT 2025 for reporting trial results—along with practical online tools to support their use. It is aimed at researchers, sponsors, methodologists and journal editors who need a structured, evidence based approach to designing and reporting high quality randomised trials.

Key content and materials include:

  • SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 checklist, expanded checklist, figure, main Statement, and an Explanation and Elaboration document that clarify what to include in a robust randomized trial protocol.
  • CONSORT (CONsolidated Standards Of Reporting Trials) 2025 checklist, expanded checklist, flow diagram, main Statement, and an Explanation and Elaboration document that guide transparent reporting of trial design, conduct, analysis and results.
  • SEPTRE (SPIRIT Electronic Protocol Tool & Resource), an online tool that allows users to create, register and manage trial protocols in line with SPIRIT recommendations, providing a structured template and workflow for protocol development.
  • COBWEB (COnsort Based WEB tool), an online writing aid that helps authors write, edit, share and export randomized trial reports that follow the CONSORT guidance, supporting complete and consistent reporting.

For investigator initiated clinical studies, the SPIRIT 2025 materials and SEPTRE tool offer a clear framework and practical support for specifying trial objectives, design, methods and ethical considerations in the protocol. The CONSORT 2025 resources and COBWEB assist research teams in preparing manuscripts that fully report trial methods and findings, improve interpretability and reproducibility, and meet journal expectations.

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