The SPIRIT 2013 Statement provides recommendations for a minimum set of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol. The Statement also details the scope and systematic development methods of the SPIRIT guidance.
The recommendations are outlined in a 33-item checklist and figure. Important details for each checklist item can be found in the Explanation & Elaboration paper, or by browsing the menu on the left. The minimum list of items is by no means exhaustive; particular types of trials warrant additional protocol elements.
By providing evidence-based guidance on key issues to address in a protocol, SPIRIT is intended to facilitate the drafting of protocols and improve their completeness. High-quality protocols can promote proper trial implementation, reduce avoidable protocol amendments, and facilitate full appraisal of the study’s scientific and ethical considerations.