MedDRA Standardized MedDRA Query (SMQ) Support

The Oracle Argus Mart data includes the assignment of SMQs based on criteria defined in the Introductory Guide for Standardised MedDRA Queries (SMQs) Version x.y, published by the International Federation of Pharmaceutical Manufacturers and Associations.

The SMQ support is as follows:

• Narrow and broad definitions of SMQs are implemented.
• Select Algorithmic SMQs are implemented.
• The (Event/SMQ) PT_plus_SMQ event variable includes values for all PTs and SMQs associated with each report, where the SMQ records have been inserted into the data as part of the Argus Mart ETL data preparation. The (Event/Narrow SMQ) PT_plus_ Narrow_SMQ event variable provides only PTs and Narrow SMQ data for data mining, querying, and reporting.

Tip:

There are no hierarchy values for SMQs in data mining results. Also, the prepared source data does not have hierarchy values for SMQs; thus, hierarchy values for SMQs do not appear in second-level drilldown (the Case Details page). Also note that SMQs do not appear in the MedDRA Hierarchy Browser.

• Calculations made by MGPS data mining runs are not affected by the addition of SMQ values in the Argus Mart data.

When you access the Release Notes and Other Documents topic under Getting Started in the Empirica Signal and Topics Online Help Table of Contents, the following documents are available:

• Introductory Guide for Standardised MedDRA Queries (SMQs) Version x.y
• Introductory Guide MedDRA Version x.y