SPIRIT 2013 statement: defining standard protocol items for clinical trials - PubMed (original) (raw)
Practice Guideline
. 2013 Feb 5;158(3):200-7.
doi: 10.7326/0003-4819-158-3-201302050-00583.
Jennifer M Tetzlaff, Douglas G Altman, Andreas Laupacis, Peter C Gøtzsche, Karmela Krleža-Jerić, Asbjørn Hróbjartsson, Howard Mann, Kay Dickersin, Jesse A Berlin, Caroline J Doré, Wendy R Parulekar, William S M Summerskill, Trish Groves, Kenneth F Schulz, Harold C Sox, Frank W Rockhold, Drummond Rennie, David Moher
Affiliations
- PMID: 23295957
- PMCID: PMC5114123
- DOI: 10.7326/0003-4819-158-3-201302050-00583
Practice Guideline
SPIRIT 2013 statement: defining standard protocol items for clinical trials
An-Wen Chan et al. Ann Intern Med. 2013.
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.
Conflict of interest statement
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1905.
Figures
Figure
Example template of recommended content for the schedule of enrollment, interventions, and assessments.
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