Data Management

A Practical Introduction to Clinical Data Acquisition Standards Harmonization (CDASH)

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Executive Summary

The goal when putting together the initial domain streams was to find out which data fields are essential to the analysis of clinical data, and collect only that data in a standard way. In order to do this, CDASH has provided clear definitions, SDTM mapping (if relevant), CRF completion instructions and additional sponsor information for each data element. The focus of CDASH is on data collection, not data reporting. In some instances the optimal data collection method conflicts with the Study Data Tabulation Model (SDTM) for reporting data. In these cases additional transformations and derivations may be needed to create the final SDTM compliant datasets.

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