EDQM Term List Loader utility

The EDQM Term List Loader utility can be used to load the EDQM Standard Terms database in Argus, to maintain a local repository for the EDQM Standard Terms database, and to synchronize the Argus code list for Routes of Administration and Dose Forms.

Field descriptions

The Argus Console application provides the EDQM option for Dictionary Management on the Tools tab of the menu bar.

When Argus Console is accessed from the Global homepage, this utility is accessible only from the default enterprise.

This utility is available only to the users with the Global Admin role configured in User Management.

The EDQM Term List Loader Utility can be used to:

• Load the EDQM Standard Terms database in Argus.
• Maintain a local repository for the EDQM Standard Terms database.
• Synchronize the Argus code list for Routes of Administration and Dose Forms.

This utility needs to be used to load the standard dictionary provided by EDQM accessed through EDQM API.

Field	Description
Dictionary File	Provide the ZIP file that contains the JSON files from the EDQM Standard Dictionary. The JSON files that belong to RoA and Formulation need to be extracted from the EDQM website and zipped before uploading. Note: We recommend you to follow the dictionary files naming convention.
Argus Code List mapping to Concept Class	The data from the Route of Administration and the Dose Formulation fields indicate the EDQM concept class terms mappings to Argus Code list.
Routes of Administration	This field is used to specify the concept class that needs to be considered to populate the EDQM Term ID in the Route of Administration codelist. The Routes of Administration codelist uses terms with ROA concept class. The default data populated in this field is ROA.
Dose Formulation	This field is used to specify the concept class that needs to be considered to populate the EDQM Term ID in the Formulation codelist. The default values are: PDF - Pharmaceutical Dose Form CDF - Combined Pharmaceutical Dosage Form BDF - Basic Dose Form PFT - Patient Friendly Term If a term belongs to multiple concept classes, the EDQM Term ID, populated in the Formulation codelist, is based on the concept class order specified in this box. Removing any concept class or changing the order from this list might result in incorrect resolution of the EDQM Term ID that may affect reporting. The changes made to concept class are effective only for successful load. For example, the Lozenge term is present in multiple concept classes as PDF-10321000, BDF-0058, PFT-13220. If the default order is retained, after a successful EDQM load, the application maps Lozenge onto the PDF-10321000 EDQM Term ID in the Formulation codelist because PDF appears first in the priority order. If the PDF concept class is removed and placed after BDF in the list, then the application maps Lozenge onto the BDF-005 EDQM Term ID. The user should not remove any concept class from the Route of Administration and Dose Formulation fields.
Notification Email Address	The user provides the list of email addresses that will receive notifications regarding the status of EDQM Load process. The email message contains the changes done to Argus Code List such as new term addition, existing term updates, and term status changes. The email address of the logged-in user is populated by default. You can enter multiple email address separated by a semicolon.
Load	When a user clicks the Load button, the EDQM standard dictionary loads the local repository and updates the Routes of Administration and Formulation codelists if the system identifies any changes. During EDQM load, the display attribute is turned off for all the new terms added to code list, and the deprecated terms as per the latest dictionary files. The EDQM local repository is common to all enterprises in a database. Loading synchronizes the codelist for each enterprise based on the files uploaded using the utility.
Cancel	The Cancel button enables the user to halt the loading process that is in progress.
Status	The Status box is refreshed automatically, displaying the progression of the Load process.

For more information on EDQM, refer to the Usage of EDQM Routes of Administration (RoA) and Dose Forms (DF) Best Practices document.