ABSTRACT
This chapter provides examples of CDISC specification compliance checks. CDISC specification compliance checks are applicable to both SDTMs and ADaMs. The CDISC specification compliance checks must pass through Pinnacle 21 checks, which most organizations run at early stage to prevent late minute SDTM and ADaM updates before submission. Initially in DDTs, SDTM character variables may be set to 200 to prevent truncation. However, by submission time, the character variables must be reset to the actual maximum length to conserve space. The FDA first checks the submission metadata to assure required components exist before even reading the data in their system. If the metadata is incomplete or incorrect based on the define.xml, the FDA may immediately reject the submission.
