An-Wen Chan, MD, DPhil; Jennifer M. Tetzlaff, MSc; Douglas G. Altman, DSc; Andreas Laupacis, MD; Peter C. Gøtzsche, MD, DrMedSci; Karmela Krleža-Jerić, MD, DSc; Asbjørn Hróbjartsson, PhD; Howard Mann, MD; Kay Dickersin, PhD; Jesse A. Berlin, ScD; Caroline J. Doré, BSc; Wendy R. Parulekar, MD; William S.M. Summerskill, MBBS; Trish Groves, MBBS; Kenneth F. Schulz, PhD; Harold C. Sox, MD; Frank W. Rockhold, PhD; Drummond Rennie, MD; David Moher, PhD
Disclaimer: Dr. Krleža-Jerić was formerly employed by the Canadian Institutes of Health Research (Knowledge Translation Branch), and Dr. Parulekar is affiliated with the NCIC Clinical Trials Group. The funders otherwise had no input into the design and conduct of the project; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. Dr. Berlin is employed by the Janssen Pharmaceutical Companies of Johnson & Johnson, Dr. Sox is Editor Emeritus of Annals of Internal Medicine, and Dr. Rockhold is employed by GlaxoSmithKline.
Acknowledgment: The authors thank Drs. Mona Loufty and Patricia Parkin for pilot-testing the SPIRIT checklist with their graduate course students. The authors also acknowledge the participation of Dr. Geneviève Dubois-Flynn in the 2009 SPIRIT meeting.
Grant Support: Financial support for the SPIRIT meetings was provided by the Canadian Institutes of Health Research (grant DET-106068), National Cancer Institute of Canada (now Canadian Cancer Society Research Institute), and Canadian Agency for Drugs and Technologies in Health. The Canadian Institutes of Health Research has also funded ongoing dissemination activities (grant MET-117434).
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1905.
Requests for Single Reprints: An-Wen Chan, MD, DPhil, Women's College Research Institute, Women's College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada; e-mail, email@example.com.
Current Author Addresses: Dr. Chan: Women's College Research Institute, Women's College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada.
Ms. Tetzlaff: Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.
Dr. Altman: Centre for Statistics in Medicine, University of Oxford, Wolfson College Annexe, Linton Road, Oxford OX2 6UD, United Kingdom.
Dr. Laupacis: Keenan Research Centre at the Li Ka Shing Knowledge Institute of St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada.
Drs. Gøtzsche and Hróbjartsson: Nordic Cochrane Centre, Rigshospitalet Department 3343, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.
Dr. Krleža-Jerić: Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario K1H 8M5, Canada.
Dr. Mann: Division of Medical Ethics and Humanities, University of Utah School of Medicine, 75 South 2000 East #108, Salt Lake City, UT 84132.
Dr. Dickersin: Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Mail Room W5010, Baltimore, MD 21205.
Dr. Berlin: Janssen Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson, 1125 Trenton Harbourton Road, Titusville, NJ 08560.
Ms. Doré: UK Medical Research Council Clinical Trials Unit, 125 Kingsway, London WC2B 6NH, United Kingdom.
Dr. Parulekar: NCIC Clinical Trials Group, Cancer Research Institute, Queen's University, 10 Stuart Street, Kingston, Ontario K7L 3N6, Canada.
Dr. Summerskill: The Lancet, 32 Jamestown Road, London NW1 7BY, United Kingdom.
Dr. Groves: BMJ, BMA House, Tavistock Square, London WC1H 9JP, United Kingdom.
Dr. Schulz: Quantitative Sciences, FHI 360, Research Triangle Park, 2224 East NC Highway 54, Durham, NC 27713.
Dr. Sox: The Dartmouth Institute for Health Policy and Clinical Practice, The Geisel School of Medicine at Dartmouth, HB 7500, Hanover, NH 03755.
Dr. Rockhold: GlaxoSmithKline, 5 Moore Drive, PO Box 13398, Research Triangle Park, NC 27709.
Dr. Rennie: The Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, 3333 California Street, Laurel Heights 265, San Francisco, CA 94143-0936.
Dr. Moher: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.
Author Contributions: Conception and design: A.-W. Chan, J.M. Tetzlaff, D.G. Altman, A. Laupacis, P.C. Gøtzsche, K. Krleža-Jerić, A. Hróbjartsson, H. Mann, K. Dickersin, J.A. Berlin, W.R. Parulekar, K.F. Schulz, H.C. Sox, D. Rennie, D. Moher.
Analysis and interpretation of the data: A.-W. Chan, J.M. Tetzlaff, D.G. Altman, A. Laupacis, P.C. Gøtzsche, K. Krleža-Jerić, A. Hróbjartsson, K. Dickersin, C.J. Doré, W.R. Parulekar, T. Groves, K.F. Schulz, F.W. Rockhold, D. Rennie, D. Moher.
Drafting of the article: A.-W. Chan, J.M. Tetzlaff, P.C. Gøtzsche, H. Mann, K. Dickersin, J.A. Berlin, C.J. Doré, W.R. Parulekar, K.F. Schulz.
Critical revision of the article for important intellectual content: A.-W. Chan, J.M. Tetzlaff, D.G. Altman, A. Laupacis, K. Krleža-Jerić, A. Hróbjartsson, H. Mann, K. Dickersin, J.A. Berlin, C.J. Doré, W.R. Parulekar, W.S.M. Summerskill, T. Groves, K.F. Schulz, H.C. Sox, F.W. Rockhold, D. Rennie, D. Moher.
Final approval of the article: A.-W. Chan, J.M. Tetzlaff, D.G. Altman, A. Laupacis, P.C. Gøtzsche, K. Krleža-Jerić, A. Hróbjartsson, H. Mann, K. Dickersin, J.A. Berlin, C.J. Doré, W.R. Parulekar, W.S.M. Summerskill, T. Groves, K.F. Schulz, H.C. Sox, F.W. Rockhold, D. Rennie, D. Moher.
Provision of study materials or patients: K. Krleža-Jerić, K. Dickersin.
Statistical expertise: D.G. Altman, P.C. Gøtzsche, C.J. Doré, K.F. Schulz, F.W. Rockhold.
Obtaining of funding: A.-W. Chan, A. Laupacis, D. Moher.
Administrative, technical, or logistic support: A.-W. Chan, P.C. Gøtzsche, K. Krleža-Jerić.
Collection and assembly of data: A.-W. Chan, J.M. Tetzlaff, P.C. Gøtzsche, A. Hróbjartsson, K. Dickersin, C.J. Doré, W.R. Parulekar, K.F. Schulz.
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.
SPIRIT 2013 Checklist: Recommended Items to Address in a Clinical Trial Protocol and Related Documents
Example template of recommended content for the schedule of enrollment, interventions, and assessments.
Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration (31) for examples. This template is copyrighted by the SPIRIT Group and is reproduced with permission. SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials.
* List specific time points in this row.
World Health Organization Trial Registration Data Set
Potential Benefits and Proposed Stakeholder Actions for Supporting Adherence to SPIRIT 2013
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Chan A, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583
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Published: Ann Intern Med. 2013;158(3):200-207.
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