Calyx RIM 6.1 CHF 4 Data Migration
The Calyx RIM 6.1 CHF 4 database migration provides the following Data Administration changes to support AU eCTD Module 1 specification v3.1 and NeeS specification v2.0.
If the AU-3-1 Assembly DTD/Schema Type already exists in the table in Data Administration, it will be activated (if inactive) and updated to have the internal code value set to AU-3-1. Otherwise, the AU-3-1 Assembly/DTD Schema Type will be added.
Filing Type Values
- If they do not already exist, Filing Type Values will be added to the table.
- If Filing Type Values already exist, they will be updated with an eCTD Code for the au-3-1 DTD/Schema.
- If the found Filing Type does not have Australia as an associated country, it will be added to the list of Countries. An appropriate Filing Type eCTD Code for au-3-1 DTD/Schema will be added to Filing Type.
- If more than one Filing Type is found with a matching eCTD Code, the one with the matching Filing Type Name will be updated with the new eCTD Code for au-3-1 DTD/Schema.
Sequence Description Values
- If they do not already exist, Sequence Description Values will be added to the table. The presence of the appropriate Sequence Description Value will be identified by a combination of eCTD Code and Applicable DTD/Schema
Regulatory Activity Lead Values
- If they do not already exist, Regulatory Activity Lead Values will be added to the table. The presence of the appropriate Regulatory Activity Lead Value will be identified by a combination of eCTD Code and Applicable DTD/Schema.