SPIRIT 2025 Checklist

Scope: Standard Protocol Items: Recommendations for Interventional Trials.

Reference: See source/archetypes/spirit-2025.yml for canonical link and provenance.

Instructions

• Use the boxes to confirm each reporting item.
• Add reviewer notes under each section as needed.

Administrative information

• 1. Title: Descriptive title that identifies the study as a randomised trial, the interventions, the trial acronym, and the SPIRIT item this protocol is based on.
• 2. Trial registration: Trial identifier and registry name. If not yet registered, name of intended registry.
• 3. Protocol version: Date and version identifier.
• 4. Funding: Sources and types of financial, material, and other support.
• 5. Roles and responsibilities: Names, affiliations, and roles of protocol contributors.

Introduction

• 6. Background and rationale: Description of research question and justification for undertaking the trial, including summary of relevant studies.
• 7. Objectives: Specific objectives or hypotheses.

Methods: Participants, interventions, and outcomes

• 8. Trial design: Description of trial design including type of trial, allocation ratio, and framework.
• 9. Study setting: Description of study settings.
• 10. Eligibility criteria: Inclusion and exclusion criteria for participants.
• 11. Interventions: Interventions for each group with sufficient detail to allow replication.
• 12. Outcomes: Primary, secondary, and other outcomes.

Methods: Assignment of interventions (for controlled trials)

• 13. Allocation: Sequence generation, concealment mechanism, and implementation.
• 14. Blinding (masking): Who will be blinded and how.

Methods: Data collection, management, and analysis

• 15. Data collection methods: Plans for assessment and collection of outcome, baseline, and other trial data.
• 16. Data management: Plans for data entry, coding, security, and storage.
• 17. Statistical methods: Statistical methods for analysing primary and secondary outcomes.

Methods: Monitoring

• 18. Data monitoring: Plans for data monitoring.
• 19. Harms: Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct.
• 20. Auditing: Frequency and procedures for auditing trial conduct.

Ethics and dissemination

• 21. Research ethics approval: Plans for seeking research ethics committee/institutional review board approval.
• 22. Protocol amendments: Plans for communicating important protocol modifications to relevant parties.
• 23. Consent or assent: Who will obtain informed consent or assent from potential trial participants or authorized surrogates, and how.
• 24. Confidentiality: How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial.
• 25. Declaration of interests: Financial and other competing interests for principal investigators for the overall trial and each study site.
• 26. Access to data: Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators.
• 27. Ancillary and post-trial care: Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation.
• 28. Dissemination policy: Plans for investigators and sponsors to authors and other stakeholders to share trial results.
• 29. Authorship eligibility: Guidelines for authorship eligibility for trial publications.
• 30. Reproducibility: Plans for sharing of original data and statistical code.

Appendices

• 31. Informed consent materials: Model consent form and other related documentation given to participants and authorized surrogates.
• 32. Biological specimens: Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable.

Notes

Provenance

• Source: See sidecar metadata in source/archetypes/spirit-2025.yml
• Version: 2025
• License: CC-BY-4.0