| Length: |
2 hours
|
| Cost: |
USD $350
|
| Course Prerequisite: |
None
|
| Objective: |
For participants to gain a
basic understanding of MedDRA and its applications in the coding, retrieval, and analysis of clinical data.
|
| Description: |
This two-hour course is designed to provide a basic understanding of the scope, structure, characteristics, and maintenance of MedDRA, and the relevant regulations concerning its use. In addition, it provides an overview of coding with MedDRA and applications of MedDRA in data retrieval and analysis, including use of Standardised MedDRA Queries (SMQs) in safety signal detection and case identification.
|
| This course is designed for: |
Subscribers who are interested in a general overview of MedDRA and its applications. This course is not intended to provide specialized training in coding or analysis.
• Medical Monitors
• Clinical Research Associates
• Clinical Operations Managers
• Regulatory Affairs Professionals
• Drug Safety/Pharmacovigilance Specialists
• Clinical Data Managers
• Programmers
• Statisticians
• Medical Writers
|
| Course Outline: |
• Overview of MedDRA development
• MedDRA's scope and structure
• MedDRA Maintenance
• Regulatory considerations
• Coding with MedDRA: Introduction to "MedDRA Term Selection: Points to Consider" document
• Introduction to "MedDRA Data Retrieval and Presentation: Points to Consider" document
• Introduction to Standardised MedDRA Queries
|
| Continuing Education Credits: |
California Board of Registered Nursing approved
credit hours: 2.4 |
