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Home > Training >MedDRA: Safety Data Analysis and SMQs

MedDRA:  Safety Data Analysis and SMQs

Length:

1 day session

Cost: USD $1,200

Course Prerequisite: A basic working knowledge of MedDRA or the Full Scope of MedDRA course or equivalent experience

Objective: For participants to review and understand the principles described in the “MedDRA Data Retrieval and Presentation: Points to Consider” document and to gain an understanding of how and why SMQs have been developed and to appreciate their utility when using databases of MedDRA-coded information.

Description:

This one day course is designed to provide an overview of the features of MedDRA that relate to the analysis and retrieval of MedDRA-encoded data. The course focuses on the use of MedDRA to retrieve and present aggregated data, based on the principles outlined in the “ MedDRA Data Retrieval and Presentation: Points to Consider ” document. A few real-life examples and hands-on exercises are included. The course also includes a thorough overview of Standardised MedDRA Queries (SMQs) and their application in the investigation of drug safety issues and in case identification. Participants learn about the development, testing and maintenance of SMQs and see detailed examples of individual SMQs.

This course is beneficial to anyone who works with and interprets MedDRA-encoded data, especially from the point of view of case review and retrieval.

This course is designed for:
    •  Drug Safety/Pharmacovigilance Professionals
    •  Clinical Monitors
    •  Medical Writers
    •  Data Coordinators
    •  Clinical Programmers
    •  Statisticians
Course Outline: MedDRA Refresher

Why Your Coded Data May Look Different

“MedDRA Data Retrieval and Presentation: Points to Consider” document

Developing Queries using MedDRA

Examples and Hands-on Exercises

Background of SMQ Development

SMQ Definitions

SMQ Data Characteristics

SMQs Development Status

SMQ Testing and Production Maintenance

Examples of Individual SMQs

Query Exercises: Comparison vs . SMQs
Continuing Education Credits: California Board of Registered Nursing approved credit hours: 6.6

 

 

 

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