The study analysis datasets and the results are the most critical component of the study submission package, since they are the base for the study conclusion and reports. Their accuracy directly determines the validity of the trial outcome.
CDISC SuiteTM enables comprehensive validation of both the analysis datasets and the results. The ADaM dataset is compared with the Define.xml, in order to make sure the contents match the metadata. The latest public ADaM validation checks as well as the extended validations through EDE-CHECKTM ensure that the ADaM datasets are compliant with the ADaM standard and logically consistent.
The TLF reports, which are one-proc-away from ADaM datasets, are checked against the analysis result Define.xml. In addition, the conformance to the TLF table shells and the coverage of SAP analysis plan are inspected for consistency and completeness.