SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)

Abstract

The SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials) contains guidance for authors of protocols for randomized and nonrandomized clinical trials. Funding agencies, institutional review boards (IRB), journals, and regulators can also use SPIRIT as their standard guidance for the content of submitted protocols. The SPIRIT initiative also includes a comprehensive Explanation and Elaboration (E&E) paper. This document provides information to promote a more complete understanding of the checklist recommendations. The author recommends that the E&E paper be used in conjunction with the SPIRIT 2013 Statement. SPIRIT 2013 can be used by investigators developing any type of clinical trial protocol, regardless of topic, intervention type, or study design. This chapter includes five items enshrining several important administrative elements of trial protocol development and conduct, including the title, protocol version, trial registration, funding, and the roles and responsibilities of the sponsor and key members of the protocol development team.

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