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. 2013 Jan 8:346:e7586.
doi: 10.1136/bmj.e7586.

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

An-Wen Chan  1 , Jennifer M Tetzlaff, Peter C Gøtzsche, Douglas G Altman, Howard Mann, Jesse A Berlin, Kay Dickersin, Asbjørn Hróbjartsson, Kenneth F Schulz, Wendy R Parulekar, Karmela Krleza-Jeric, Andreas Laupacis, David Moher
Affiliations

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

An-Wen Chan et al. BMJ. .

Abstract

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

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Figures

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Fig 1 Example template for the schedule of enrolment, interventions, and assessments (recommended content can be displayed using other schematic formats)
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Fig 2: Flow of participants
See this image and copyright information in PMC

References

    1. World Medical Association. WMA Declaration of Helsinki—ethical principles for medical research involving human subjects. 2008. www.wma.net/en/30publications/10policies/b3/index.html.
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