Practice Test Geeks(PVC) Pharmacovigilance Certification Practice Test
← All PVC Flashcard Decks

Medical Coding & MedDRA Terminology Flashcards

7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Medical Coding & MedDRA Terminology flashcards as text

  1. In E2B(R3) electronic adverse event reporting, which data format is used to transmit Individual Case Safety Reports (ICSRs)?

    Answer: HL7 XML format

    E2B(R3) uses the HL7 XML schema for electronic transmission of ICSRs, enabling structured, machine-readable data exchange between regulatory agencies and manufacturers.

  2. What does 'SMQ' stand for in the context of MedDRA?

    Answer: Standardized MedDRA Query

    SMQ stands for Standardized MedDRA Query, which are validated, pre-defined search strategies used to retrieve cases associated with a specific medical condition from safety databases.

  3. What is the primary purpose of Standardized MedDRA Queries (SMQs) in pharmacovigilance?

    Answer: To provide validated search strategies for identifying cases of a defined medical condition

    SMQs provide validated, pre-defined search strategies that allow pharmacovigilance professionals to systematically retrieve relevant cases related to a specific safety concern from large databases.

  4. At which MedDRA level is data typically entered during verbatim coding, but NOT primarily used for regulatory submission analysis?

    Answer: Lowest Level Term (LLT)

    LLTs are used as the data entry level to capture verbatim terms, but regulatory analysis and signal detection are conducted at the PT level and above.

  5. What is the function of the High Level Group Term (HLGT) in the MedDRA hierarchy?

    Answer: Grouping related High Level Terms (HLTs) for broader categorical analysis

    HLGTs group related HLTs together, providing an intermediate grouping level between HLT and SOC that facilitates broader categorical analysis of safety data.

  6. Which of the following represents best practice in medical coding quality review?

    Answer: Ensure the selected PT accurately and specifically reflects the clinical concept described

    Quality coding requires that the selected PT accurately and specifically represents the clinical concept, balancing specificity with the available terminology.

  7. What process is required in a pharmacovigilance safety database when transitioning to a new MedDRA version?

    Answer: MedDRA recoding or version upgrade of existing terms

    MedDRA recoding (version upgrade) involves reviewing and updating existing coded terms in the safety database to align with changes, additions, or deletions in the new MedDRA version.