Trial Monitoring Section
SPIRIT 2025 added a trial-monitoring item for protocols, reflecting the need to describe planned oversight of trial conduct rather than relying on an older auditing-only item. Monitoring intensity and form depend on trial risk, design, sponsor, jurisdiction, and applicable regulation. Do not present one monitoring model as universal.
A Trial Monitoring section describes the planned oversight used to check trial conduct, participant protection, data quality, and compliance with the protocol and applicable requirements.
Key details
Important caveats
Scope Boundary
Monitoring intensity and form depend on trial risk, design, sponsor, jurisdiction, and applicable regulation. Do not present one monitoring model as universal.
Further guidance
Content
Describe the monitoring approach, scope, responsibility, timing or triggers, and how findings or required actions are handled; link to more detailed monitoring documents when appropriate.
Purpose
Explain how trial conduct will be monitored and who is responsible for that oversight.
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.