Condensed Points to Consider Documents and MedDRA Best Practices Document are Available

9 November 2018

On behalf of the ICH M1 Points to Consider (PtC) Working Group, the MSSO is pleased to announce the posting of the Condensed versions of the MedDRA Term Selection and Data Retrieval and Presentation Points to Consider documents on the Support Documentation page of the MedDRA website.
 
The Condensed versions focus on the fundamental principles of term selection and data retrieval, and are intended to support the implementation and use of MedDRA in the ICH regions and beyond. They are available in all MedDRA languages except for English and Japanese; the English and Japanese PtC documents will continue to be maintained and updated as the full reference documents. Please select the relevant language to navigate to the specific translation of the document.
 
In addition, the MedDRA Best Practices document has been posted on the Support Documentation page. The purpose of the document is to provide the recommendations of the MSSO for the implementation and use of MedDRA. Topics include primary SOC allocation rules, versioning, and use of supplemental terms. It is available in all MedDRA languages. 

MedDRA users are invited to contact the MSSO Help Desk with any questions or comments.