From: The SPIRIT Checklist—lessons from the experience of SPIRIT protocol editors
• SPIRIT items left blank or marked N/A without rationale | |
• Page numbers missing from protocol but referenced in the SPIRIT Checklist | |
• Failure to provide any details about the groups involved in trial oversight and management | |
• Incomplete description of randomization and allocation processes | |
• Not including enough detail or justification in the sample size calculation to allow replication | |
• Not enough detail on how potential harms will be assessed | |
• Failure to specify how authorship will be determined in future trial publications (including any use of professional writers) | |
• Failure to include a model consent form or (alternatively) details about its contents | |
• Failure to consider the collection of blood and biomarker levels as “biological specimens” |