Dictionary Loader/Recoding Self Service

Summary

Support Dictionary Loading self-service interface for MedDRA, WHODrug, J-Drug dictionaries, and MedDRA Recode

Description

Two new menu items have been added to Argus Console > Tools > Dictionary Management:

• Dictionary Loader
• MedDRA Recode

The new options can be used as an alternative to the Dictionary Management Client/Server tool.

For CRO setup, the utility is accessible to the users that belong to a default enterprise and a group with Menu access.

The Dictionary Loader option supports loading the below Dictionary Types. The Dictionary Type new codelist includes the following values:

• MedDRA
• MedDRA J
• WHODrug Global (Formats B2/B3; C/C3)
• WHODrug Chinese (Formats B3; C3)
• J-Drug

The Dictionary Loader utility provides the option to load a new dictionary or overwrite a dictionary as per the existing functionality as the Dictionary Management Client/Server tool. To load the dictionary, you need to:

• Upload the dictionary files in ZIP format from local desktop.
• Upload the MDB file for the Dictionary [MedDRA, WHO Drug or J Drug dictionaries].
• Select the dictionary type.
• Select the dictionary version and other mandatory information to initiate the loading process.

After initiating the load, the application automatically creates the dictionary schema and the user based on the selected Dictionary Type and Version. On the Dictionary Loader interface, you can view the terms loading status and progress. After the successful completion or failure of the load, you can download the log files. An email is also sent to one or more users configured in the Dictionary Loader interface.

The application performs a rollback if there is any failure during loading, and the status is displayed in the Dictionary Loader interface.

The dictionary loading happens in the background, meaning that the user who initiated the loading can navigate to other screens and resume other tasks. The application allows loading one dictionary at a time. Other dictionaries can be loaded subsequently after completing the prior load. Similarly, the dictionaries loading and recoding cannot be done in parallel and they need to be sequentially executed.

Note:

The MDB files are provided along with the Argus installation and they contain the list of dictionary versions along with the queries to load the data into the database. Periodically, Oracle releases MDB files with newer versions and the customers can download and use them by referring to My Oracle Support and can find more details in Argus Safety Administration Guide. The MDB file is required to be loaded only once per dictionary type. A subsequent upload is required only when the dictionary version number shown in the utility is not reflecting the latest dictionary that is required to be loaded.

The MedDRA Recode functionality is used to recode the already coded MedDRA terms to the MedDRA dictionary version configured in System Configuration.

The new interface from Argus Console is similar to the existing recode option in the Dictionary Management Client/Server tool.

In a CRO setup, the MedDRA Recoding tool only recodes the items that match the selected enterprises and the selected MedDRA version to recode. You can recode:

• Current terms only
• Non-Current terms only
• Update dictionary version

Recoding can be done in View Only or Update mode. In View Only mode, cases are not updated or recoded, but a log is made available with the potential cases that are impacted. The View only mode allows the users to select the target version on the MedDRA Recode window without changing the dictionary version in System Management (Common Profile Switches). In Update mode, the cases are actually recoded and audit logged. The Target dictionary is the dictionary version that is selected in Argus Console > Common Profile Switch for each enterprise. You can download the logs from the MedDRA Recode interface after recoding in either mode.

The supported log files are the same as in the Dictionary Management Client/Server tool.

The recoding logic remains the same.

For more details on Dictionary Loading and Recoding features, refer to Argus Safety Administration Guide.