Primary SOC | PharmaBharat Tools

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Primary 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 EntryPrimary SOC

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System Organ Class (SOC)Multi-SOC

Primary SOC

Case Processing & Data Entry

Definition

Single primary SOC assigned to PT for case (MedDRA allows one primary).

Example

PT Myocardial infarction—primary SOC Cardiac.

Regulatory source

MedDRA

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