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MedDRA Version Upgrades - Oracle Argus Safety (Doc ID 1078923.1)

Last updated on MAY 26, 2020

Applies to:

Oracle Argus Safety Japan - Version 6.0 and later
Oracle Argus Safety - Version 3.0.2 and later
Information in this document applies to any platform.

Purpose

To provide the information necessary to upgrade MedDRA versions on several Argus Safety product versions.

Scope

* UPDATE * April 19, 2020: MSSO re-released MedDRA 23.0 English and Japanese Versions (details here).  No change to the MDB file is required since the MedDRA version re-released by MSSO is still being called 23.0.  As a result companies can load the updated MedDRA 23.0 version using the same MDB file provided earlier.

NOTE: For companies who have already installed the old MedDRA 23.0 files in production, we suggest not to use the “Overwrite” option and use the following:

1.    Rename the “old” MedDRA 23.0 dictionary entries in Argus using the following simple SQL statement (note: the name is max 30 characters so only a few extra characters can be added):



2.    Proceed to load the new MedDRA 23.0 files as a new dictionary using standard loading process
3.    Run recoding as needed

NOTE: We have posted an updated MDB file in the table below which is specific to Argus versions 8.2.1.1 or 8.2.1.2 only.  Do NOT use this file on versions below 8.2.1.1.

* UPDATE * April 13, 2020: MedDRA MSSO has announced an urgent updated version of MedDRA 23.0 will be released as a result of COVID-19 (details here).  At the moment there does not appear to be any impact to the MDB file already provided by Oracle for 23.0.  However we won't be 100% certain until MSSO provides any new updates or releases the final files (currently targeted for April 19).  Once this happens Oracle will update this note again with our latest feedback.

* UPDATE * March 11, 2020: Oracle has released the updated MDB file to support MedDRA version 23.x. It can be accessed from the table listed below.

Details

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