The SDTM is designed to enhance the production of which type of data set?

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The Study Data Tabulation Model (SDTM) is specifically designed to enhance the production of case report tabulations. This model provides a standardized format for organizing clinical trial data, ensuring consistency and facilitating the submission process to regulatory authorities. Case report tabulations are essential for summarizing the findings from clinical studies in a structured way that allows for easier review and analysis.

By using SDTM standards, data from clinical trials can be more efficiently transformed into a format that meets regulatory requirements, which is crucial for the approval and assessment of new drugs. This standardization helps streamline the review process by providing clear organization of the study data, enhancing both quality and efficiency in data reporting.

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