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.
authors.forename: An-Wen
authors.initials: AW
authors.lastname: Chan
authors.affiliation: Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Tetzlaff
authors.affiliation: Centre for Statistics in Medicine, Universidad de Oxford.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.affiliation: Keenan Research Centre at the Li Ka Shing Knowledge, Institute of St. Michael's Hospital.
authors.forename: Andreas
authors.initials: A
authors.lastname: Laupacis
authors.affiliation: Nordic Cochrane Centre, Rigshospitalet.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Gøtzsche
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa.
authors.forename: Karmela
authors.initials: K
authors.lastname: Krle A-Jerić
authors.affiliation: Nordic Cochrane Centre, Rigshospitalet.
authors.forename: Asbjørn
authors.initials: A
authors.lastname: Hrobjartsson
authors.affiliation: Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, Estados Unidos.
authors.forename: Howard
authors.initials: H
authors.lastname: Mann
authors.affiliation: Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, Estados Unidos.
authors.forename: Kay
authors.initials: K
authors.lastname: Dickersin
authors.affiliation: Janssen Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson, Titusville, Estados Unidos.
authors.forename: Jesse A
authors.initials: JA
authors.lastname: Berlin
authors.affiliation: UK Medical Research Council Clinical Trials Unit, Reino Unido.
authors.forename: Caroline J
authors.initials: CJ
authors.lastname: Dore
authors.affiliation: NCIC Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, Canadá
authors.forename: Wendy R
authors.initials: WR
authors.lastname: Parulekar
authors.affiliation: The Lancet, Reino Unido.
authors.forename: William S M
authors.initials: WS
authors.lastname: Summerskill
authors.affiliation: BMJ, Reino Unido.
authors.forename: Trish
authors.initials: T
authors.lastname: Groves
authors.affiliation: Triangle Park, North Carolina, Estados Unidos.
authors.forename: Kenneth F
authors.initials: KF
authors.lastname: Schulz
authors.affiliation: Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Hanover, Estados Unidos.
authors.forename: Harold C
authors.initials: HC
authors.lastname: Sox
authors.affiliation: Triangle Park, North Carolina, Estados Unidos.
authors.forename: Frank W
authors.initials: FW
authors.lastname: Rockhold
authors.affiliation: PR Lee Institute for Health Policy Studies, University of California, San Francisco, Estados Unidos.
authors.forename: Drummond
authors.initials: D
authors.lastname: Rennie
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa.
authors.forename: David
authors.initials: D
authors.lastname: Moher
mesh_terms: D035843:Biomedical Research; D057189:Checklist; D002986:Clinical Trials as Topic; D012108:Research Personnel