| Summary: | <bold>Objective: </bold>To provide researchers, clinicians and policy makers with a primer to study designs, statistical approaches and graphical reporting methods for suicide research in real world data (RWD).<bold>Methods: </bold>Study designs, statistical method and graphical reporting standards are detailed with examples from the recently published literature.<bold>Results: </bold>Data sources and codes for identifying suicidal behavior are described. Study designs are described in detail for post-market surveillance, retrospective cohort studies, case control and nested case-control studies, and self-controlled (within-individual) studies including applications of marginal structural models. Graphical reporting of designs is described using an original research study.<bold>Conclusions: </bold>Compared to RCTs, RWE studies offer larger sample sizes, greater generalizability, and real-world validity. However, these non-experimental data risk uncontrolled confounding and potential introduction of bias unless data, design and statistical approaches are rigorously aligned.
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