Create Submission and Reference Entity
Use the different entities to create submissions and references.
When you submit the form for
Create Submission and Reference business process type, the entities are created in
Ennov InSight
:
- Sequence
- Reference
Sequence entity fields:
| Field Name | Description | IM Req (Y/N) |
|---|---|---|
| Family Code | Product Family code associated with the sequence. | N/A |
| Family Name | Product Family associated with the sequence. | N/A |
| Application Code | Application Code associated with the sequence. | N/A |
| Application Name | Application associated with the sequence. | N/A |
| Included in Grouped Submission | Displayed only for SPT and ELP license modules. The field shows the hyperlink for which the sequence is associated to the submission plan. | N/A |
| Closed | Indicates that the sequence is closed. | N/A |
| Sequence Code | Code that identifies a specific submission associated with the application. For eCTD submissions, these codes begins with "0000". | N/A |
| Sequence Name | Descriptive name to identify the sequence. | N/A |
| Sequence Status | Current status of the sequence. | N/A |
| Sequence Status Date | Date the status was set. | N/A |
| Reason for Termination/Withdrawal | Reason the sequence was terminated or withdrawn. | |
| Filing Type | Available filing types depend on the selected country and application type for the associated application. | N/A |
| Reviewing Country | Reviewing Country on the application associated with the sequence. | N/A |
| Co-Rapporteur | Current Co-Rapporteur on the CP type application. Displayed only for CP type applications. | N/A |
| Concerned Member States | For MRP/DCP type applications only. | N/A |
| Procedure Type | Current Procedure Type for the application associated with the sequence. | N/A |
| Events | Identifies the Event related to the sequence.
Available Events: Multi select. Selected Events: Events currently associated with the sequence. |
N/A |
| Sequence Category | In the US: for Supplements, you must identify the category. (CBE, CBE30, etc.) | N/A |
| Electronic Output Location | Location where the electronic output is stored. | N/A |
| Paper Reference | Reference information/identification for paper submissions. | N/A |
| Origination | Name of an item the sequence was created in reference to. | N/A |
| Lifecycle Order | Displayed only for SPT, RDA, ELP license modules. An integer that indicates the order in which a sequence was added to lifecycle, irrespective of the sequence number. This provides a definitive ordering for all sequences within an application. | |
| Owner | Person responsible for the sequence. | N/A |
| Sequence Concerned Parties | Enter email addresses. | N/A |
| Sequence Keywords | Enter the search criteria. | |
| Sequence Description | Sequence description entered in the Add-in form. | N/A |
| Sequence Comments | When modifying, displays previously added comments. | N/A |
Reference entity fields:
| Field Name | Description | IM Req (Y/N) |
|---|---|---|
| Family Code | Code of the product family associated with the reference. | N/A |
| Family Name | Name of the product family associated with the reference. | N/A |
| Reviewing Country | Reviewing Country on the application associated with the reference. | N/A |
| Application Code | Application Code associated with the reference. | N/A |
| Sequence Name | Descriptive name to identify the sequence. | N/A |
| Reference Name | Name of the reference, must be unique within its parent entity. | Y |
| Entity Association | Entity type associated with the reference. References can be associated to: Product Family, Product (Full Product Name concatenation), Application, Event, Sequence Assembly, License, Task. | N/A |
| Entity Name | Entity Name associated with the reference. References can be associated to: Product Family, Product (Full Product Name concatenation), Application, Event, Sequence Assembly, License, Task. | N/A |
| Type | Type of reference. | Y |
| Content | Additional information to identify the type of reference and what the content references. Examples: Mock-Up, Meeting Minutes, Notes, Time Table, etc. | N |
| Participant | Who the reference was to or from. Examples: Agency/Agency Name, internal departments, affiliates, etc. | N |
| Reference Status | Current status of the reference. | Y |
| Reference Status Date | Date the current status was set. | Y |
| Reference Link Type | Type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Reference Link | Link to the reference. Click Select to locate and choose the reference. | N |
| Origination | Short description, identifies what caused the correspondence contained in the reference. (Examples: questions from authority, request from affiliate, etc.) | N |
| Origination Link Type | Type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Origination Link | Link to the correspondence. Click Select to locate and choose the correspondence. | N |
| Action | Short description, identifies the Action taken to address the reference/correspondence. | N |
| Action Link Type | Type of Link. Examples: Assembly, DMS, URL, File Folder | N |
| Action Link | Link to the item. Click Select to locate and choose the action. | N |
| Reference Concerned Parties | Enter email addresses. | N |
| Reference Keywords | Enter search criteria. | |
| Reference Description | Enter descriptive information. | N |
| Reference Comment | N/A | N/A |