MedDRA Points to Consider

NOTE: Changes to the Points to Consider documents are anticipated for MedDRA Version 13.1 (September 2010). In the MedDRA Term Selection: Points to Consider document, these changes will be an addition of the sixth Blue Ribbon Panel’s recommendation on MedDRA versioning (http://www.meddramsso.com/MSSOWeb/activities/blueribbonpanels.htm, “BRP 6 Recommendations”), and addition of coding points for product quality and medical device terms. The PTC Working Group is also considering format changes to the Term Selection document (and also the Data Retrieval and Presentation: Points to Consider document); these would consist of a general streamlining of the documents to reduce their size and improve their readability. No major change in the content of either document is anticipated.

MedDRA Term Selection: Points to Consider Document

ENGLISH

• ENGLISH Release 3.14 (.pdf) Based on MedDRA Version 13.0
• Summary of Changes from Release 3.13 (.pdf)

JAPANESE

• JAPANESE Release 3.14 (Requires Acrobat Reader with Japanese Language Support Package) (.pdf) Based on MedDRA Version 13.0)
• Summary of Changes from Release 3.13 (.pdf)

MedDRA Data Retrieval and Presentation: Points to Consider Document

ENGLISH

• ENGLISH Release 2.2 (.pdf) Based on MedDRA Version 13.0
• Summary of Changes from Release 2.1 (.pdf)

JAPANESE

• JAPANESE Release 2.2 (Requires Acrobat Reader with Japanese Language Support Package) (.pdf) Based on MedDRA Version 13.0
• Summary of Changes from Release 2.1 (.pdf)

Please email any questions to: mssohelp@ngc.com or call at +1 877.258.8280.

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