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We used piloted forms to screen and extract data relevant to specific checklist items.Studies were included if they provided empirical data to support or refute the importance of a given protocol concept.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.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.

The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol.To identify examples for each checklist item, we obtained protocols from public websites, journals, trial investigators, and industry sponsors.Model examples were selected to reflect how key elements could be appropriately described in a trial protocol.When no review was identified, we either cited all relevant individual studies, or if too numerous, a representative sample of the literature.Some items had little or no identified empirical evidence (eg, title) but their inclusion in the checklist is supported by a strong pragmatic or ethical rationale.

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Some examples illustrate a specific component of a checklist item, while others encompass all key recommendations for an item.