Prerequisites

The ZIP file should contain the dictionary files (.xlsx files) and should not have embedded ZIP files or folders.

Note:

In the Dictionary Loader self-service option, the new schema and user are automatically created for every dictionary load.

About the IMDRF file

The dictionary file contains all Annex excel files for A to G in the .xlsx format. The format of this .xlsx file should not be modified by the user, especially the position of data in columns.

The user can load IMDRF files with FDA code columns or without FDA code columns. The FDA code columns are FDA Code and NCIt Code. These columns are the additional columns provided by FDA on top of the IMDRF published Annex files.

If the file format is not as expected, Argus will throw error message prompting the user to reselect correct files.

The file also contains a Status column with the following values:

• New – A new record to be added
• Retired / Not selectable – An obsolete record to be soft deleted
• Modified – An updated record to update the existing record
• Null – An existing record with no change required