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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.

Type

Journal article

Journal

BMJ

Publication Date

08/01/2013

Volume

346

Keywords

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