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ready Standard Protocol Items: Recommendations for Interventional Trials

Abbreviation: SPIRIT

General Information
The protocol of a clinical trial is essential for study conduct, review, reporting, and interpretation. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol.


Countries that developed this resource Canada , Denmark , United Kingdom , United States

Created in 2013

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How to cite this record SPIRIT; Standard Protocol Items: Recommendations for Interventional Trials; DOI:; Last edited: Jan. 8, 2019, 1:35 p.m.; Last accessed: Sep 27 2021 5:39 a.m.

Record added: Nov. 1, 2016, 1:41 p.m.
Record updated: Jan. 8, 2019, 1:35 p.m. by The FAIRsharing Team.

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

Chan AW,Tetzlaff JM,Altman DG,Laupacis A,Gotzsche PC,Krleza-Jeric K,Hrobjartsson A,Mann H,Dickersin K,Berlin JA,Dore CJ,Parulekar WR,Summerskill WS,Groves T,Schulz KF,Sox HC,Rockhold FW,Rennie D,Moher D
Ann Intern Med 2013

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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

Chan AW,Tetzlaff JM,Gotzsche PC,Altman DG,Mann H,Berlin JA,Dickersin K,Hrobjartsson A,Schulz KF,Parulekar WR,Krleza-Jeric K,Laupacis A,Moher D
BMJ 2013

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