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