TY - JOUR
T1 - SPIRIT 2013 Statement
T2 - defining standard protocol items for clinical trials
AU - Chan, An Wen
AU - Tetzlaff, Jennifer M.
AU - Altman, Douglas G.
AU - Laupacis, Andreas
AU - Gøtzsche, Peter C.
AU - Krle A-Jerić, Karmela
AU - Hrobjartsson, Asbjørn
AU - Mann, Howard
AU - Dickersin, Kay
AU - Berlin, Jesse A.
AU - Dore, Caroline J.
AU - Parulekar, Wendy R.
AU - Summerskill, William S.M.
AU - Groves, Trish
AU - Schulz, Kenneth F.
AU - Sox, Harold C.
AU - Rockhold, Frank W.
AU - Rennie, Drummond
AU - Moher, David
PY - 2015/12/1
Y1 - 2015/12/1
N2 - 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.
AB - 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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M3 - Article
C2 - 27440100
AN - SCOPUS:85023758059
SN - 1020-4989
VL - 38
SP - 506
EP - 514
JO - Revista panamericana de salud publica = Pan American journal of public health
JF - Revista panamericana de salud publica = Pan American journal of public health
IS - 6
ER -