title: SPIRIT 2013 statement: defining standard protocol items for clinical trials.
abstract: The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
authors.affiliation: Women’s College Research Institute, Women’s College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada. anwen.chan@utoronto.ca
authors.forename: An-Wen
authors.initials: AW
authors.lastname: Chan
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Tetzlaff
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.forename: Andreas
authors.initials: A
authors.lastname: Laupacis
authors.forename: Peter C
authors.initials: PC
authors.lastname: Gøtzsche
authors.forename: Karmela
authors.initials: K
authors.lastname: Krleža-Jerić
authors.forename: Asbjørn
authors.initials: A
authors.lastname: Hróbjartsson
authors.forename: Howard
authors.initials: H
authors.lastname: Mann
authors.forename: Kay
authors.initials: K
authors.lastname: Dickersin
authors.forename: Jesse A
authors.initials: JA
authors.lastname: Berlin
authors.forename: Caroline J
authors.initials: CJ
authors.lastname: Doré
authors.forename: Wendy R
authors.initials: WR
authors.lastname: Parulekar
authors.forename: William S M
authors.initials: WS
authors.lastname: Summerskill
authors.forename: Trish
authors.initials: T
authors.lastname: Groves
authors.forename: Kenneth F
authors.initials: KF
authors.lastname: Schulz
authors.forename: Harold C
authors.initials: HC
authors.lastname: Sox
authors.forename: Frank W
authors.initials: FW
authors.lastname: Rockhold
authors.forename: Drummond
authors.initials: D
authors.lastname: Rennie
authors.forename: David
authors.initials: D
authors.lastname: Moher
mesh_terms: D057189:Checklist; D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D006801:Humans