[O365] Create Submission and Reference
Use the Create Submission and Reference form to start the submission and reference workflow in Calyx RIM.
For successful form submission, the workflow contains the activities and its supporting attributes.
QC and update submission
| 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 |
| 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 |
| Procedure Type | Current Procedure Type for the application associated with the sequence. | N/A |
| Sequence Name | Descriptive name to identify the sequence. | Y |
| Sequence Status | Current status of the sequence. | Y |
| Sequence Status Date | Date the status was set. | Y |
| Filing Type | List of Filing Type is dependent on the selected country and application type for the associated application. | Y |
| Concerned Member States | Displayed for MRP/DCP applications only. | N |
| Owner | Person responsible for the sequence. | N |
| Sequence Category | In the US for Supplements, you must also identify the category. (CBE, CBE30, etc.) | N |
| Electronic Output Location | Location where the electronic output is stored. | N |
| Paper Reference | Reference information/definition for paper submissions. | N |
| Origination | Name of an item the sequence was created in reference to. | N |
| Event | Identifies the Event for which the sequence is related.
Available Events: Multi select. Selected Events: Events currently associated with the sequence. |
N |
| Sequence Concerned Parties | Enter email addresses. | N |
| Sequence Description | Display Sequence Description that was entered in the Add-in form. | N |
| Sequence Add Comments | Enter information that will be stamped with the Date/Time/User ID of the person entering the information. | N |
QC and update reference
| 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 |
| Application Code | Application Code associated with the reference. | N/A |
| Application Name | Application associated with the reference. | N/A |
| Reviewing Country | Reviewing Country on the application associated with the reference. | N/A |
| 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 |
| Reference Name | Name of the reference. The reference name must be unique within its parent entity. | Y |
| 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 | Identifies the 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 Description | Enter descriptive information. | N |
| Reference Add Comment | N/A | N/A |
When the workflow is triggered but a reference for the submission is not created, the workflow contains the following activities and their supporting attributes.
QC and update submission - The activity fields are same as described in the QC and update reference table.
Review and create reference - The following activity fields are displayed:
| 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 |
| Application Code | Application Code associated with the reference. | N/A |
| Application Name | Application associated with the reference. | N/A |
| Reviewing Country | Reviewing Country on the application associated with the reference. | N/A |
| 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 |
| Reference Name | Name of the reference. The reference name must be unique within its parent entity. | Y |
| Type | Type of reference. | Y |
| Content | Additional information to further identify the type of reference as to what is the content in reference to. 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 Description | Enter descriptive information. | N |
| Reference Add Comment | N/A | N/A |
When the workflow is triggered but a submission for the application is not created, the workflow contains the following activities and their supporting attributes.
Review and create submission - The following activity fields are displayed:
| 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 |
| 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 |
| Procedure Type | Current Procedure Type for the application associated with the sequence. | 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 |
| Filing Type | Available filing types depend on the selected country and application type for the associated application | N/A |
| Concerned Member States | For MRP/DCP type applications only. | N/A |
| Owner | Person responsible for 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 sequences. | N/A |
| Origination | Name of an item the sequence was created in reference to. | N/A |
| Events | IEvent related to the sequence.
Available Events: Multi select Selected Events: Events currently associated with the sequence |
N/A |
| Sequence Concerned Parties | Enter email addresses. | N/A |
| Sequence Description | Sequence description entered in the Add-in form. | N/A |
| Sequence Add Comments | Information entered is stamped with the Date/Time/User ID of the person entering the information. | N/A |
Review and create reference - The fields are same as described in the Review and create submission table.