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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.
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.
A clinical trial is a prospective study in which one or more interventions are assigned to human participants in order to assess the effects on health related outcomes.
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.
We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. 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.
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.High quality protocols facilitate proper conduct, reporting, and external review of clinical trials.