Dictionary coding and categorization variables provided in the SDTM should be included as needed for analysis, review, or traceability. Common coding variables are provided in this section. If other coding variables are included in the SDTM and pertinent for analysis, these should be included in ADaM using a similar naming convention as shown here. For any public versioned dictionary, the metadata for each coding variable should include both the name and version of the dictionary.
MedDRA coding is typically used for adverse events and medical history. Copy the needed MedDRA terms and codes from SDTM to the analysis dataset.
For the SubClass ADVERSE EVENT, it is required that all levels of terms for the primary path in the MedDRA hierarchy—System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Lowest Level Term (LLT), and Preferred Term (PT)—be included. For other OCCDS datasets, these variables are recommended (they are frequently useful in further analyses of events), but not required.
Overview
Content Tools