ABSTRACT

This chapter provides examples of SDTMs and ADaMs vital checks. SDTMs and ADaMs vital checks assure data integrity when data flows from raw data to SDTMs and then finally to ADaMs. Dataset level checks include vitals, dataset transfer, group descriptive statistics, zero dataset records, and disposition population tree checks. Vital checks provide summarized information on key SDTMs and ADaMs so that organizations have the confidence to accept and process the data. Since data is constantly transferred from vendors with different schedules based on the type of data, organizations must be proactive in controlling the acceptance of each data transfer. In additional to the traditional data management steps to check the quality of data, the CDISC compliance checks in this publication will expedite FDA’s review in an automated and standardized process. Dataset functions are used to open datasets, count number of records and read files, as well as get metadata information.