Special Instructions: Bring your own laptop
Please arrive by 8:45.
NOTES:
-- This training will be conducted in English. -- Facility Entry Requirements
Participants will arrive at the 675 campus, main lobby (bldg.10) there are signs that will lead you to the correct building; visitor parking is also available. Participants will get registered and receive their badge and be escorted to the meeting room. In addition to the information you submit with your on-line course registration, you will need to provide your phone number. The MSSO will request this additional information closer to the class dates. -- This class is limited to two persons per organisation. However, if space is available, please contact the MSSO training desk, mssotraining@meddra.org, for consideration to add registrants from your company.
Continuing Education Credits: California Board of Registered Nursing approved credit hours: 8.4 hours.
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 1-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:
Course outline:
Drug safety/pharmacovigilance professionals Clinical monitors Medical writers Data coordinators Clinical programmers Statisticians MedDRA overview MedDRA Data Retrieval and Presentation: Points to Consider document Developing queries using MedDRA Examples and hands-on exercises SMQ background and definition SMQs development status SMQ data characteristics SMQ testing and production maintenance SMQ versioning SMQ applications Customised searches
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