The purpose of this document is to provide examples of traceability using ADaM. Please refer to ADaM v2.1, ADaMIG v1.2 and the ADaM OCCDS v1.0 for required background about ADaM and ADaM data structures.
The ADaMIG states: To assist review, ADaM datasets and metadata must clearly communicate how the ADaM datasets were created. The verification of derivations in an ADaM dataset requires having at hand the input data used to create the ADaM dataset. A CDISC-conformant submission includes both SDTM and ADaM datasets; therefore, it follows that the relationship between SDTM and ADaM must be clear. This requirement highlights the importance of traceability between the analyzed data (ADaM) and its input data (SDTM).
Traceability is built by clearly establishing the path between an element and its immediate predecessor. The full path is traced by going from one element to its predecessors, then on to their predecessors, and so on, back to the SDTM datasets, and ultimately to the data collection instrument.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.