ABSTRACT

This chapter provides a variety of data checks across several types of SDTMs and ADaMs. The SDTMs and ADaM data-level checks are consistent with Pinnacle 21 checks. Missing values in required variables can cause SAS program errors as well as prevent raw data to SDTM refreshes. ISO8601 datetime and time checks confirm all SDTM character date time format variables follow ISO8601 rules. The benefit of SDTMs having character date variables is to allow for raw partial date and time values. The compare related variables check confirm logically, consistency and integrity across variables within and across SDTMs. The duration check confirms consistency between duration variable and start and end date or time variables. This is ideal when the duration variable is collected on the case report form or when duration is calculated in ADaMs. Data range checks valid values by confirming all values are within the minimum and maximum acceptable values.