| Length: |
1-day session |
| Cost: |
Free for MedDRA Subscribers |
| Course Prerequisite: |
None
|
| 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 query development 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. Participants learn about the development, testing and maintenance of SMQs and see detailed examples of individual SMQs. Examples of practical applications of SMQs for case identification and safety signal detection are presented. |
| This course is designed for: |
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.
- Drug Safety/Pharmacovigilance Professionals
- Clinical Monitors
- Medical Writers
- Data Coordinators
- Clinical Programmers
- Statisticians
|
| Course Outline: |
- MedDRA Overview
- MedDRA Data Retrieval and Presentation: Points to Consider document
- Developing Queries using MedDRA
- Examples and Hands-on Exercises
- Background of SMQ Development
- SMQ Data Characteristics
- SMQs Development Status
- SMQ Testing and Production Maintenance
- SMQ Versioning
- SMQ Applications
- Customized Searches
- Query Exercises: Comparison vs . SMQs
|
| Continuing Education Credits: |
California Board of Registered Nursing approved credit hours: 8.4 |
