Entity Fields, Columns and Options Added: Ennov InSight 7.3
The following tables describe fields and columns that were added in this release. These include the fields and columns that were added to support IDMP data capture and eCTD 4.0 publishing standards.
Home
Table 1: I am Looking To
| Field/Column/ Option Name | Field Type | Description | Business Rules |
| IDMP Data Generation | Tab | The new IDMP Data Generation wizard is available from My Home > I am Looking To | The ability to capture IDMP data in Ennov InSight in preparation for submitting IDMP data to EMA. |
Ennov InSight RIM 7.3 Release Notes
Cumulative
Ennov InSight 7.3 COB and Known Issues
Table 2: Assembly Templates
| Field/Column/ Option Name | Field Type | Description | Business Rules |
| eCTD Standard Type | Read-only field |
This column is added to Home > Assembly Templates grid view. |
The eCTD Standard Type column contains the eCTD 3.2, eCTD 4.0, Paper, NeeS types based on the values displayed for this field on the Assembly Attributes page. |
Notifications
Table 3: Notifications
|
Field/ Column/ Option Name |
Field Type | Description | Business Rules |
|
Sequence Standard Type |
Option |
To conform to the new eCTD 4.0 requirements, the Select Rule Settings and Delivery Destinations page now includes the respective option when you create or modify the notification from the: — Notifications tab of an appropriate entity — My Home > I am Looking To > Create new > Notifications — Data Administration > Notifications or Data Administration > Notification Specifications |
The ability to separate different submission standards and use the functionality defined by the selected standard. |
Table 4: Assembly Templates
| Field/Column/ Option Name | Field Type | Description | Business Rules |
| eCTD Standard Type | Read-only field |
This column is added to Home > Assembly Templates grid view. |
The eCTD Standard Type column contains the eCTD 3.2, eCTD 4.0, Paper, NeeS types based on the values displayed for this field on the Assembly Attributes page. |
Entities
Application
Table 5: Application
|
Field/Column/Option Name |
Field Type | Description | Business Rules |
|
Sender-defined Keywords Codesystem |
Read-only field |
To conform to the new eCTD 4.0 requirements, the Application Attributes page now includes the respective field. | Defines code system of the sender-defined keywords for application. |
Table 6: Sender-defined Keywords
| Field/Column/ Option Name | Field Type | Description | Business Rules |
|
Application Name |
Read-only field |
To conform to the new eCTD 4.0 requirements, the Sender-defined | The ability to manage the sender-defined |
|
Application Codesystem ID |
Read-only field |
Keywords tab is introduced on the Application Attributes page. | keywords. |
| Code | Hyperlink | ||
| Display Name | Text field |
Sequence
Table 7: Sequence
|
Field/ Column/ Option Name |
Field Type | Description | Business Rules |
|
Sequence Standard Type |
Dropdown list |
The Sequence Attributes page now | — The Sequence Standard Type field contains eCTD 3.2, eCTD 4.0, Paper, NeeS. If the eCTD 4.0 set for this sequence is changed to any other value, it results in Switch from |
| UUID | Text field | includes these fields. |
eCTD 4.0 standard type is for sequence with existing assembly is disallowed. error message. — The system generates automatically the UUID value (version 4 of UUID types) on sequence creation. The UUID field is visible on the modification and view pages only. Only user with Admin permissions to the sequence can modify the field. The values should be unique (case-insensitive). The entered values should pass the validation to match the format: a hexadecimal number in the form of xxxxxxxx-xxxxxxxx-xxxx-xxxxxxxxxxxx, having 32 digits and 4 hyphens. If format does not match, the The UUID must be in the form of xxxxxxxx-xxxx-Mxxx-Nxxx-xxxxxxxxxxxx, where x is a hexadecimal number, M is 1-5, and N is 8, 9, a or b. message is displayed. If uniqueness is violated, the The UUID must be unique. message appears. |
Manufactured Item
Table 8: Manufactured Item
|
Field/Column/Option Name |
Field Type | Description | Business Rules |
| Manufactured Item Quantity Operator |
Drop-down list |
The Manufactured Item Attributes page now includes this field. |
The values for this field are available from the Data Administration > Other > Concentration Measure Type Values |
Attached Document
Table 9: Attached Document
| Field/Column/ Option Name | Field Type | Description | Business Rules |
|
Attachment Document Status |
Drop-down list |
The Attached Document Attributes page now includes this field. |
To conform to the latest IDMP specification released, the new attribute has been added to the entity. The values for this field are available from the Data Administration > Other > Attached Document Status Values |
|
Attached Document URL |
Browse field |
The Attached Document Attributes page now includes this field. | To conform to the latest IDMP specification released, the new attribute has been added to the entity. |
Medicinal Product Action
Table 10: Medicinal Product Action
| Field/Column/ Option Name | Field Type | Description | Business Rules |
| DV | Option | The Medicinal Product Attributes page now includes this option. | To conform to the latest IDMP specification released, the new attribute has been added to the entity. |
| Field/Column/ Option Name | Field Type | Description | Business Rules |
| Family Code | Hyperlink | The Medical Devices node now | To conform to the latest IDMP |
| Family Name | Hyperlink | includes the Function node with the corresponding fields. | specification released, the new attribute has been added to the |
|
Application Code |
Hyperlink | entity. | |
|
Application Name |
Hyperlink | ||
| Product Name | Hyperlink | ||
|
Product Detail Set Name |
Hyperlink | ||
| Component Name | Hyperlink | ||
| Function Name |
Drop-down list |
||
| Function Status |
Drop-down list |
||
| Function Status Date | Date | ||
| QC Status | Read-only | ||
| Date QC'd | Read-only | ||
| QC'd by | Read-only | ||
| Function Keywords | Text field | ||
|
Function Description |
Text field | ||
| Function Comments | Text field | ||
| Family Code | Hyperlink | The Medical Devices node now | |
| Family Name | Hyperlink | includes the Manufacturer node with the corresponding fields | |
|
Application Code |
Hyperlink | associated to the new Function node . | |
|
Application Name |
Hyperlink | ||
| Product Name | Hyperlink | ||
|
Product Detail ©Ennov 2024Set Name |
Hyperlink | 27 | Ennov InSight RIM 7.3 Release Notes Cumulative |
|
EnnovComponent Name |
Hyperlink | Entity Fields |
Product Detail Set Table 11: Medical Devices
Table 12: Package Set
|
Field/Column/Option Name |
Field Type | Description | Business Rules |
|
— Package Item Quantity Operator — Package Item - MI Quantity Operator — Device Quantity Operator |
Box, text field | The Package Set > Packaging > Package Detail Attributes page now includes this field. | The values for this field are available from the Data Administration > Other > Concentration Measure Type Values. |
| Pack Size Quantity Operator | Box, text field | The Package Set > Pack Size > Pack Size Detail Attributes page now includes this field. |
Table 13: Indication/Intended Use
|
Field/Column/Option Name |
Field Type | Description | Business Rules |
|
— Intended Effect — Comorbidity — Countries |
Multi-select | The Indication/Intended Use node now includes the Intended Effect/ Comorbidity sub-node with the respective fields. |
Multiple sub-nodes can be created for the same Indication but Country values will not be available for selection. Country values are available only when you create a new sub-node for another Indication. If all values for the Country field are selected, it will not be possible to create a new sub-node unless you modify or delete the existing one. |
Assembly
Table 14: Assembly Attributes
| Field/Column/ Option Name | Field Type | Description | Business Rules |
| eCTD Standard Type | Read-only field | The Assembly Attributes page now includes this field. | To identify the eCTD type for incorporating forward capability, this new option is added. |
Wizards
Table 15: Create Application
|
Field/Option Name |
Field Type | Description | Business Rules |
|
Sequence Standard Type |
Dropdown list |
These fields are now available for the Create Application wizard | The field contains eCTD 3.2, eCTD 4.0, Paper, NeeS. If there is eCTD 4.0 set for this sequence changes to any other value, it results in Switch |
| UUID | Text field | when creating a sequence. | from eCTD 4.0 standard type is for sequence with existing assembly is disallowed. error message. |
Table 16: Create Submission
|
Field/ Option Name |
Field Type | Description | Business Rules |
|
Sequence Standard Type |
Dropdown list |
These fields are now available in the Create Submission wizard | — The Sequence Standard Type field contains eCTD 3.2, eCTD 4.0, Paper, NeeS. If there is eCTD 4.0 set for this sequence changes to any other value, it results in |
| UUID | Text field |
when creating a sequence using following options: — Initial Application — Major Update — Amendment |
Switch from eCTD 4.0 standard type is for sequence with existing assembly is disallowed. error message. — The system generates automatically the UUID value (version 4 of UUID types) on sequence creation. The UUID field is visible on the modification and view pages only. Only user with Admin permissions to the sequence can modify the field. The values should be unique (case-insensitive). The entered values should pass the validation to match the format: a hexadecimal number in the form of xxxxxxxx-xxxxxxxx-xxxx-xxxxxxxxxxxx, having 32 digits and 4 hyphens. If format does not match, the The UUID must be in the form of xxxxxxxx-xxxxMxxx-Nxxx-xxxxxxxxxxxx, where x is a hexadecimal number, M is 1-5, and N is 8, 9, a or b. message is displayed. If uniqueness is violated, the The UUID must be unique. message appears. |
Table 17: Global Project Plan
Field/ Field Option Type Name
Sequence Drop-
Standard down Type list
UUID Text field
Description
These fields are now available for the Global Project Plan wizard when creating a sequence using following project types:
— Create New Events
Package Set Registration
— Сlinical Trial
- Create New CTA and/or IND Application(s)
- Create New CTA
Application(s) and
Create New Event for
Existing IND
Application(s)
- Create New Event for
Existing CTA and/or
IND Application(s)
— Create New Events
Product Registration
— Create New Applications
Package Set Registration Business Rules
— The Sequence Standard Type field contains eCTD 3.2, eCTD 4.0, Paper, NeeS. If there is eCTD 4.0 set for this sequence changes to any other value, it results in Switch from eCTD
4.0 standard type is for sequence with existing assembly is disallowed. error message.
— The system generates automatically the UUID value (version 4 of UUID types) on sequence creation. The UUID field is visible on the modification and view pages only. Only user with Admin permissions to the sequence can modify the field. The values should be unique (case-insensitive). The entered values should pass the validation to match the format: a hexadecimal number in the form of xxxxxxxxxxxx-xxxx-xxxx-xxxxxxxxxxxx, having 32 digits and 4 hyphens. If format does not match, the
The UUID must be in the form of xxxxxxxx-xxxx-Mxxx-Nxxxxxxxxxxxxxxx, where x is a hexadecimal number, M is 1-5, and N is 8, 9, a or b. message is displayed. If uniqueness is violated, the The UUID must be unique. message appears.
|
Field/Option Name |
Field Type | Description | Business Rules |
|
Active Ingredients |
Selection widget | This field is updated with improved Substance Search selection widget. | Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page. |
Table 18: IDMP Data Generation
|
Field/Option Name |
Field Type | Description | Business Rules |
| Family Type | Multiselect | Ennov InSight now introduces the new IDMP Data Generation wizard | The ability to capture IDMP data in Ennov InSight in preparation for |
| Family Name | Multiselect | available from Wizards > IDMP Data Generation. | submitting IDMP data to EMA. |
| Product Name | Multiselect | ||
|
Application Name |
Multiselect | ||
| Action Name | Text field | ||
| Status | Multiselect | ||
| Display Columns | Multiselect | ||
| Sort Order | Multiselect |