Which storage format is used for a value collected on a case report form that is not defined in an SDTM domain?

In clinical trials data management, when a value collected on a case report form does not fit into a predefined SDTM (Study Data Tabulation Model) domain, the SUPPQUAL storage format is utilized. SUPPQUAL stands for "Supplemental Qualifiers," and it is specifically designed for capturing additional data that complements existing SDTM datasets. This allows for the inclusion of important data that may be relevant for the study but does not have a dedicated structure in the standard SDTM domains.

Using SUPPQUAL ensures that additional information can be systematically documented and linked back to the relevant SDTM records. It is particularly useful in accommodating unique trial circumstances, regulatory needs, or specific data not anticipated during the design of the SDTM domains.

The other choices are different types of storage formats or standards but do not serve the same purpose as SUPPQUAL in relation to data not defined in a standard SDTM domain.