Home > Training > Data Quality, Coding and MedDRA Training Module
FREE COURSE
Data Quality, Coding and MedDRA Training Module
Length:
Undetermined
Course Prerequisite:
None
Objective:
To provide MedDRA subscribers with a tool to help improve the quality of initial data
Description:
The MSSO developed this course based on feedback from subscribers who are interested in improving the quality of initial data. Good quality data is essential for meaningful coding, data retrieval, and analysis using MedDRA. The course materials provide a general discussion of the importance of collecting quality data and the role of MedDRA. The presentation has a "place holder" slide for subscribers to customize the course with their own company-specific data collection and reporting conventions. This feature can be a very useful adjunct for investigator training.
This course is designed for:
• Investigators
• Study Coordinators
• Pharmaceutical company and CRO personnel, including physicians
• CRAs
• Safety officers
• Statisticians
• Programmers
• Data managers
Course Content:
• Clinical Trial regulations and the increasing emphasis on
safety surveillance and data quality
• How and why data are coded
• Definition and features of MedDRA
• Regulatory Mandate
• Specific examples of coding issues including problems with
use of abbreviations, multiple or combination terms, vague or
ambiguous terms
• Diagnoses and safety signals
• Benefits of quality data
Continuing Education Credits:
None
(Click here for Free Download for subscribers. Log-in required)
