SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

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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.

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Author and article information

Journal

Journal ID (iso-abbrev): Rev. Panam. Salud Publica

Title: Revista panamericana de salud publica = Pan American journal of public health

ISSN (Electronic): 1680-5348

ISSN (Print): 1020-4989

Publication date (Electronic): Dec 2015

Volume: 38

Issue: 6

Affiliations

[1 ] Women's College Research Institute Women's College Hospital.

[2 ] Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute.

[3 ] Centre for Statistics in Medicine, Universidad de Oxford.

[4 ] Keenan Research Centre at the Li Ka Shing Knowledge, Institute of St. Michael's Hospital.

[5 ] Nordic Cochrane Centre, Rigshospitalet.

[6 ] Department of Epidemiology and Community Medicine, University of Ottawa.

[7 ] Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, Estados Unidos.

[8 ] Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, Estados Unidos.

[9 ] Janssen Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson, Titusville, Estados Unidos.

[10 ] UK Medical Research Council Clinical Trials Unit, Reino Unido.

[11 ] NCIC Clinical Trials Group, Cancer Research Institute, Queen's University, Kingston, Canadá

[12 ] The Lancet, Reino Unido.

[13 ] BMJ, Reino Unido.

[14 ] Triangle Park, North Carolina, Estados Unidos.

[15 ] Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Hanover, Estados Unidos.

[16 ] PR Lee Institute for Health Policy Studies, University of California, San Francisco, Estados Unidos.

[17 ] Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa.

Article

Publisher Item ID: S1020-49892015001100011 Mid ID: CAMS6261

DOI: 10.7326/0003-4819-158-3-201302050-00583

PMC ID: 5114122

PubMed ID: 27440100

SO-VID: 95abf7d6-29d5-47bf-a6f0-aabc65325828

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