Data Administration Sections Added: Ennov InSight 7.3
The following Data Administration tables, sections, options, widgets, filters or fields were added for Ennov InSight 7.3.
Data Administration: Application Maintenance
Table 37: Regulatory Entitlement Status Values
| Entity Affected | Field Name | Value List Description |
| N/A |
— Regulatory Entitlement Status Name — Term ID — Term Name — Description — Last User Updated — Last Changed Date — Active Flag — RMS Term ID — RMS Modified On — RMS Status |
To conform to IDMP requirements, the Regulatory Entitlement Status Values table with the corresponding fields and RMS tab is introduced in Data Administration. This list is mapped to the SPOR Master Lists > Regulatory Entitlement Status. |
Data Administration Section: Medical Device Maintenance
Table 38: Device Classification Values
| Entity Affected | Field Name | Value List Description |
| N/A |
— Device Classification Name — Countries — Term ID — Term Name — Description — Last User Updated — Last Changed Date — Active Flag |
To conform to IDMP requirements, the Device Classification Values table with the corresponding fields is introduced in Data Administration. |
Data Administration Section: eCTD 4.0 Submission Maintenance
Table 39: CV Profile Values
| Entity Affected | Field Name | Value List Description |
| Publishing Settings Library |
— CV Profile Name — Region — Version — Category — Specification Name — Specification OID — Last User Updated — Last Changed Date — Active Flag |
To enable new controlled vocabularies to easily work with future eCTD 4.0 specification updates, the CV Profile Values table is introduced. |
Table 40: CV Details
| Entity Affected | Field Name | Value List Description |
| Publishing Settings Library |
— Name — Version — OID — Can be associated? — Can be disassociated? |
To show the set of controlled vocabularies currently associated with selected eCTD 4.0 CV profile, the CV Details table is introduced. |
Table 41: Sender-defined Keyword Values
| Entity Affected | Field Name | Value List Description |
| Publishing Settings Library |
— Code — Display Name — Last User Updated — Last Changed Date — Active Flag |
To maintain a new controlled vocabularies improvement for quick and easy eCTD 4.0 specification updates in future, the Senderdefined Keyword Values table is introduced. |
Data Administration Section: Other
Table 42: Attached Document Status Values
| Entity Affected | Field Name | Value List Description |
| Attached Document |
— Attached Document Status Name — Last User Updated — Last Changed Date — Active Flag |
To conform to IDMP requirements, the Attached Document Status Values table with the corresponding fields is introduced in Data Administration. |
Table 43: Source of Information Values
| Entity Affected | Field Name | Value List Description |
| N/A |
— Source of Information Name — Term ID — Term Name — Description — Last User Updated — Last Changed Date — Active — RMS Term ID — RMS Modified On — RMS Status |
To conform to IDMP requirements, the Source of Information Values table with the corresponding fields and RMS tab is introduced in Data Administration. This list is mapped to the SPOR Master Lists > Source of Information. |
Data Administration Section: SPOR Master Lists
| Entity Affected | Field Name | Value List Description |
| N/A |
— List Id — List Name — List Owner — Term Id — Term Name — Short Name — Status — Domain — Modified On — Mapping Source — Source Term Id — XEVMPD Code — Description — Comments — Version Number — ISO Code |
To conform to IDMP requirements to capture additional RMS data, the following tables are introduced: — Container Category — eCTD EU Context of Use — Medical Device Classification — Medical Device Legislative Category — Medicinal Product Type — Medicine Profile — Regulating Authority Submission Unit Type — Source of Information |
Data Administration Section: Submission Maintenance Table 44: Applicant Contact Type Values
| Entity Affected |
Field/Column Name |
Value List Description |
| Applicant Contact Type | eCTD Standard Type | To conform to the new eCTD 4.0 requirements, the Applicant Contact Type Values table now includes the this column. |
| Applicant Contact Type |
— Region — CV OID — Code — Value |
To make the applicant contact type updates compatible with eCTD 4.0, the applicant contact type values now can be added using the Associate eCTD 4.0 Applicant Contact Type option taking values directly from the corresponding controlled vocabulary. |