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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 searched MEDLINE, the Cochrane Methodology Register, and the Cochrane Database of Systematic Reviews (limited to reviews) up to September 2009, and EMBASE up to August 2007.

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The availability of examples for all checklist items indicates the feasibility of addressing each recommended item in the main protocol rather than in separate documents.

Examples are quoted verbatim from the trial protocol.

Proper names of trial personnel have been abbreviated with italicised initials, and any reference numbers cited in the original quoted text are denoted by [] to distinguish them from references cited in this E&E paper.

For each checklist item we also strived to provide references to empirical data supporting its relevance, which we identified through a systematic review conducted to inform the content of the SPIRIT checklist.

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials.

However, the completeness of trial protocols is often inadequate.

To meet the needs of these diverse stakeholders, protocols should adequately address key trial elements.

However, protocols often lack information on important concepts relating to study design and dissemination plans.2 3 4 5 6 7 8 9 10 11 12 Guidelines for writing protocols can help improve their completeness, but existing guidelines vary extensively in their content and have limitations, including non-systematic methods of development, limited stakeholder involvement, and lack of citation of empirical evidence to support their recommendations.13 As a result, there is also variation in the precise definition and scope of a trial protocol, particularly in terms of its relation to other documents such as procedure manuals.14Given the importance of trial protocols, an international group of stakeholders launched the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Initiative in 2007 with the primary aim of improving the content of trial protocols.

Every clinical trial should be based on a protocol—a document that details the study rationale, proposed methods, organisation, and ethical considerations.1 Trial investigators and staff use protocols to document plans for study conduct at all stages from participant recruitment to results dissemination.

Funding agencies, research ethics committees/institutional review boards, regulatory agencies, medical journals, systematic reviewers, and other groups rely on protocols to appraise the conduct and reporting of clinical trials.

Modelled after other reporting guidelines,17 18 this E&E paper presents each checklist item with at least one model example from an actual protocol, followed by a full explanation of the rationale and main issues to address.

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