DRAFT
To reiterate: It is important to note that the choice of biomedical concepts included in this user guide is not intended to influence sponsor decisions regarding what data to collect. The examples included are intended to show how particular kinds of data can be represented using CDISC standards. This user guide emphasizes that examples are only examples and should not be over-interpreted. For guidance on the selection of biomedical concepts and endpoints, please refer to the appropriate clinical and regulatory authorities.
Overview
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