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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.
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.
If information for a recommended item is not yet available when the protocol is being finalised (eg, funding sources), this should be explicitly stated and the protocol updated as new information is obtained.
Formatting conventions such as a table of contents, glossary of non-standard or ambiguous terms (eg, randomisation phase or off-protocol), and list of abbreviations and references will facilitate understanding of the protocol.
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.
Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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.
This E&E paper provides important information to facilitate full understanding of each checklist item, and is intended to be used in conjunction with the SPIRIT 2013 Statement.14 These complementary tools serve to inform trial investigators about important issues to consider in the protocol as they relate to trial design, conduct, reporting, and organisation.
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.