System Organ Class (SOC) | PharmaBharat Tools

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System Organ Class (SOC) | PharmaBharat Tools

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Duplicate Detection Follow-Up Information MedDRA Coding Case Narrative Time to Onset(TTO)Concomitant Medication Batch/Lot Number Outcome of Reaction Data Lock Overdose Off-Label Use MedDRA Hierarchy WHO Drug Dictionary Dose Regimen Indication Route of Administration Parent Case Linked Case Case Closure Pending Follow-Up Seriousness Reclassification Verbatim Term Lowest Level Term(LLT)High Level Term(HLT)System Organ Class(SOC)Primary SOC Multi-SOC Case Identifier Report Number Autopsy Batch Number Case Narrative Concomitant Medication(ConMed)Data Lock Dechallenge Drug Dictionary E2B Format(E2B)Individual Case Safety Report(ICSR)Lowest Level Term(LLT)Medical Dictionary for Regulatory Activities(MedDRA)Medical History Outcome Preferred Term(PT)Product Quality Complaint(PQC)Rechallenge System Organ Class(SOC)Suspect Drug Time to Onset(TTO)Verbatim Term

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PV Case Processing & Data EntrySystem Organ Class

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High Level Term (HLT)Primary SOC

System Organ Class(SOC)

Case Processing & Data Entry

Definition

Highest level of MedDRA (e.g., Cardiac disorders, Hepatobiliary).

Example

SOC: Hepatobiliary disorders.

Regulatory source

MedDRA

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