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.
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