| 2 | Direct Mapping | If a value can be collected exactly as it will be reported in the tabulation dataset (i.e., same value, same data type, same meaning, same controlled terminology), the tabulation variable name will be used as the data collection variable name in the operational database to streamline the mapping process. Extensions may be appended if needed to create a unique variable name in the collection database. Any collection variable whose meaning is the same as tabulation variable will align with tabulation variable and the meaning will not be modified for data collection. |
| 3 | No Direct Mapping | If a study requires a field that is not identical to an SDTMIG field value cannot be collected in alignment with a tabulation dataset variable (e.g., collected data type is different from the data type in the corresponding SDTMIG tabulation variable) , or if the SDTMIG tabulation variable is derived from the collected datavalue, then the operational database should database should use a collection variable with a different name from the SDTMIG tabulation variable into which it will be mapped .
Example 1: A study collects Findings data in a denormalized format and then maps the data to the normalized SDTM structure. The --TESTCD values can be used as the CDASHIG variable names, and the corresponding --TEST value can be used as the prompt on the CRF. (See Section 8.3.1, General CDASH Assumptions for Findings Domains, for more information.)Example 2: Dates and times are collected in a local format, familiar to the CRF users, and then reported in the SDTM-specified ISO 8601 format. In the operational database, the CDASH variables --DAT and --TIM (if collected) map into the single SDTM variable (--DTC). Example 3: If the mapping to SDTM is similar, but not direct, "C" can be included before the root variable name to indicate a "collected" version of the variable to which that data will map. For example, if an injection is to be administered to a subject’s left thigh, right thigh, left arm, or right arm, the sponsor may create the variable EXCLOC. The SDTM mapping would split these into EXLOC and EXLAT, which would avoid having to split the collection of the data into 2 fields on the CRF.An SDTM variable that is not defined in the SDTM version being used by the sponsor can be included as a non-standard variable (NSV)/supplemental qualifier. If a study requires a field that is not defined in CDASH and the SDTM with the same meaning or intent (e.g., would map to SDTM SUPP--)as a tabulation variable, a unique name should be assigned based on sponsor business rules using CDASH naming fragments (e.g., --DAT, --TIM) as appropriate and CDISC variable naming fragments where possible. (See the SDTMIG appendices.) |