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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.

Original publication

DOI

10.1136/bmj.e7586

Type

Journal article

Journal

BMJ (Clinical research ed.)

Publication Date

08/01/2013

Volume

346

Addresses

Women's College Research Institute at Women's College Hospital, Department of Medicine, University of Toronto, Toronto, Canada M5G 1N8.

Keywords

Humans, Treatment Outcome, Clinical Protocols, Data Collection, Random Allocation, Sample Size, Professional Role, Research Design, Patient Selection, Time Factors, Quality Control, Ethics, Medical, Social Responsibility, Computer Security, Research Personnel, Medical Audit, Clinical Trials Data Monitoring Committees, Clinical Trials as Topic, Research Support as Topic, Statistics as Topic, Practice Guidelines as Topic, Checklist