PVC Medical Coding & MedDRA Terminology 3

Question 1

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

Accepted Answer

HL7 XML format

Answer

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

Question 2

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

Accepted Answer

Standardized MedDRA Query

Answer

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.

Question 3

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

Accepted Answer

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

Answer

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.

Question 4

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

Accepted Answer

Lowest Level Term (LLT)

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Medical Coding & MedDRA Terminology 3