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A research study is typically composed of several phases, including design, performance, analysis, and reporting. Careful study design is the first critical step to ensure the validity of obtained results (Fig. 11.1). Depending on the type of clinical question to be answered, different types of study designs will be appropriate. Clinical questions can be divided in the following categories:(1) evaluation of effectiveness of interventions,(2) identification of underlying disease etiologies,(3) evaluation of diagnostic test accuracy, and (4) evaluation of prognostic indicators. Researchers should invest significant time in planning the research study and in drafting a comprehensive protocol. Study protocols are considered the single-most important quality control tool for observational and experimental studies, and besides being important for the research group to stimulate proper planning of the study, their public access is …