ABSTRACT
This chapter provides an overview of level of checks for systemic and detail issues. A key benefit of creating a system of compliance checks in-house is that organizations have more control over of the types and methods to manage data issues. Since metadata is an integral component of the compliance check process, an in-house system assures a higher quality source of data and checks throughout the SDTM and ADaM creation process. The data management plan in many organizations details when and how checks are applied to assure protocol compliance and data quality. Along with statistical programming departments, data management departments can benefit from these compliance checks. The difference between CDISC data and specifications compliance levels are based on data content rules and data structure rules. SAS programmers need to write compliance checks before confirming database lock and assuring CDISC compliance.
