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About SPIRIT

The trial protocol provides guidance to individuals conducting the study, serves as the basis for trial registration, and facilitates study appraisal by participants and external reviewers, including research ethics committees/institutional review boards, funders, regulators, journal editors, and systematic reviewers. However, there is accumulating evidence that many protocols do not fully address important study elements. Incomplete protocol content can impair understanding and implementation of the trial; reduce efficiency of protocol review; and lead to burdensome protocol amendments.

In 2007, an international group of stakeholders (the SPIRIT Group) launched the SPIRIT initiative to help improve the completeness and quality of trial protocols. The evidence-based SPIRIT recommendations were developed using systematic, transparent methodology and broad consultation with 115 experts representing diverse stakeholders involved in the design, funding, conduct, review, and publication of trial protocols.

The final products consist of the SPIRIT 2013 Statement and the accompanying Explanation & Elaboration paper, which were published in January 2013. SPIRIT 2013 builds on other applicable international guidance by citing empirical evidence and providing additional recommendations. It adheres to the ethical principles mandated by the 2008 Declaration of Helsinki, and encompasses the protocol items recommended by the International Conference on Harmonisation Good Clinical Practice E6 guidance. SPIRIT 2013 also supports trial registration requirements from the World Health Organization and the International Committee of Medical Journal Editors.

SPIRIT Checklist
Publications & Downloads
SEPTRE (SPIRIT Electronic Protocol Tool & Resource)