Much ADaM about nothing — a proc away in a day

AbstractCDISC is rapidly becoming adopted as the data standard for clinical trials and submissions of clinical trial data to the FDA. Within CDISC, ADaM datasets are an integral part of clinical study analysis and require significant data derivation to fulfill the needs of TLF provision. Can the creation of ADaM datasets be automated? Yes! This paper proposes an Excel-driven solution which greatly improves the efficiency and accuracy of ADaM dataset creation by defining ADaM dataset structure, complex variable derivation, and data checks within Excel. Using a library of SAS macros, the definitions then drive the automated production of SAS scripts which produce analysis ready datasets that meet the ADaM specification and which can be validated in accordance with regulatory requirements. Additionally, data check reports are created for Data Management to speed up the data cleaning process.