" /> Study Design - CISMeF





Preferred Label : Study Design;

NCIt synonyms : Research Design; Experimental Design; Experiment Design;

NCIt related terms : designType;

NCIt definition : A plan detailing how a study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and defining the methods of data analysis. Study design is driven by research hypothesis being posed, study subject/population/sample available, logistics/resources: technology, support, networking, collaborative support, etc.;

Alternative definition : CDISC: A strategy that specifies the structure of a study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.; CDISC-GLOSS: A strategy that specifies the structure of a study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study. NOTE: Additional elements may include choice of control group(s), method of allocating treatments, blinding methods, and minimization of bias. [After Pocock, Clinical Trials: a Practical approach; After ICH E8; After ICH E9] See also Trial Design Model, arm, epoch, visit, parallel trial, crossover trial.; MRCT-Ctr: The way a study is set up to answer the study question. (https://mrctcenter.org/glossaryterm/study-design/);

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05/05/2025


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