SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guides clinical trial protocol reporting.

Promote complete and transparent clinical trial protocols before results are known.

Who should use it

Clinical trial investigators and protocol authors.

Required for clinical trial protocol publications.

• Administrative information
• Introduction and objectives
• Trial design and interventions
• Outcomes and sample size
• Ethics and dissemination
• Appendices for schedules and consent

• Trial registration
• Primary endpoint definition
• Statistical analysis plan
• Ethics approval status

• Undefined primary endpoint
• Missing statistical analysis plan
• Incomplete intervention description