Major Update Submission Attributes

You can use the attributes to modify submission attributes.
Attribute Description
Application Code The agency-identified application number (or identifier), which may not be known until the time of submission, so it may be the same as the internal code.
Application Name The name of the application that is associated with the submission event. The value is a concatenation of [Application Code + Application Name].
Countries When the Reviewing Country is a member of the European Union (EU), the Concerned Member States attribute appears and enables you to select multiple countries for the submission. This section does not appear if the Reviewing Country is not a member of the EU or for applications of national procedure type.
Create Sequence Determines whether the wizard will create a sequence for the application.
Description Text that describes the submission.
Event Code The code your organization uses to identify the event.Note: The event code and event name as a combination for an event must be unique within an application.
Event Name The name of the event.Note: The event code and event name as a combination for an event must be unique within an application.
Timeline/Event Plan A timeline/event plan determines the ordered progression of event statuses that will apply for events created from the plan.
Timeline/Event Plan Type The type of timeline/event plan used to create or update the event. The timeline/event plan type can be procedure type, event type, or none. An event created or updated by using the procedure type of timeline/event plan has a sequence of statuses that are relevant to the procedure type selected for the event. An event created or updated by using the event type of timeline/event plan has a sequence of statuses that are relevant to the event type selected for the event. An event created or updated by specifying none for the timeline/event plan type can have any sequence of active statuses. The sequence of statuses for a timeline/event plan type is defined in Data Administration.
Event Type The type of event.
Family Name/Code The product family with which to associate application you are updating.
Filing Type The filing type for the application.
Keywords Words used to search for when creating a submission.
Reason Reason for creating, modifying or deleting a submission.
Reason for Comments Comments related to reason entered by users
Reviewing Country The country performing the submission review. Only the countries associated with the application will be listed. When the Reviewing Country is a member of the European Union (EU), the Concerned Member States attribute appears and enables you to select multiple countries for the submission except for EU national procedure type applications. The wizard automatically sets the Reviewing Country for national applications.
Sequence Code The identifier for the sequence associated with the application, which is required only if a sequence will be created. The sequence code defaults to the next available four-digit sequence number, prepended with the letter P to indicate that this is the planned sequence number. This enables working on multiple planned sequences concurrently. When you mark the sequence as submitted, Ennov InSight Manager reconfirms the next available sequence number and removes the P. If you enter a value that deviates from the default format, the wizard displays a message requiring you to confirm that you want to deviate from the default numbering format.For the very first sequence in an application, the start sequence code from the application is always used. For subsequent sequences, all the sequences in the application are considered. When the highest existing sequence number has been determined, the default sequence number for the new sequence is the highest plus one. For example, if there are four sequences with the codes P0000, 0001, 0005, and R0006-512, the next sequence number by default is P0006.
Sequence Standard Type The following standard types are available for selection:
  • NeeS
  • Paper
  • eCTD 3.2
  • eCTD 4.0
UUID UUID (version 4 of UUID types) is a universal unique identifier that is automatically generated by the system on sequence creation. This field is visible and available for modification and view pages only.
  • The value can be modified only by users with Administrator permissions to the sequence.
  • Through the eCTD wizard, users with appropriate permissions are able to modify the UUID to support sequences that may require a different UUID. In most cases, the UUID value should not change. The UUID field is not available in case of sequences bulk update.
Note: 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-xxxx-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-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.
User ID The user name to validate user identity.
Password The user password to validate user identity.