Sequence Attributes

The attribute descriptions will help you to enter appropriate sequence attribute values while creating a sequence. The following table lists all the attributes that are available to you in the Enter Sequence Details page while creating a sequence.


Attribute	Description
Application Code	Agency-identified application number (or identifier); may not be known until submittal time, therefore it may be the same as the internal code.
Application Name	The name of the application.
Assign Workflow	Defines the workflow that will be associated with the sequence automatically when the sequence is created.
Closed	Indicates whether the sequence is completed.
Concerned	For a DCP (Decentralised Procedure) or MRP (Mutual Recognition Procedure) application, the countries that may review the application; cannot be changed.Note: Withdrawn application countries with the With


Attribute	Description
Member States (Available/Sele ed)	draw Date value equals to today’s date or earlier are not available for selection in the Concerned Member States multi-select field on the Create Sequence page. ct
Member States Concerned	This field is available for a EU CTR (EU Clinical Trial Regulation Procedure) only.
Concerned Parties	Users who may be copied on notifications about this entity; use semi-colons (;) to separate e-mail addresses.
Co-Rapporteur	For a CP application, the co-rapporteur associated with the sequence; cannot be changed.
Electronic Output Location	The path name where the published output exists.
Events	Events associated with the sequence.
Filing Type	The sequence filing type.
Included in Grouped Submission	The hyperlinked name of the submission plan that the sequence is associated with.
Lifecycle Order	The order of this sequence in the lifecycle; cannot be changed.
Owner	The person responsible for the sequence.
Origination	Text about the item associated with the sequence.


Attribute	Description
Paper Reference	Any text about paper documents associated with the sequence.
Procedure Type	Identifies the strategy used in a regulatory approval process for a particular set of regulatory requirements.
Rapporteur	For a CP application, the country associated with the sequence; cannot be changed.
Reason for Termination/Withdrawal	The reason that sequence was terminated or withdrawn.
Reason	Reason for creating, modifying or deleting a sequence.

Reason for Comments	Comments related to reason entered by users.
Reference Member State	For an MRP application, the member state to perform the initial assessment of a submission for the purposes of attaining a marketing authorization; cannot be changed.
Reviewing Country	The country that will review the application. When European Union (EU) is selected, multiple country selections are possible.
Sequence Add Comment	Comments you want to share with others in a discussion thread. Will be displayed in the Sequence Comments box, stamped with the date and time you enter the information and your user ID.Note: The Sequence Add Comment field is available on the Create/Modify Sequence Attributes pages only.
Sequence Category	The category for the sequence.


Attribute	Description
Sequence Code	A default value for the sequence to be associated with the application. For the very first sequence in an application, the recommended default is taken from the Application's Starting Sequence Number, however, this number can be changed. For subsequent sequences, all the sequences in the application are considered, though a default of P, followed by four digits is presented and is recommended for eCTD filings. 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 Comments	The discussion thread that includes all comments entered by users; includes the date and time the comments were entered and the user ID of the person who entered them.
Sequence Description	Text that describes the sequence.
Sequence Keywords	Words you can use to search for the sequence.
Sequence Name	The name of the sequence.
Sequence Status	The status of the entity.
Sequence Status Date	The date the entity status is effective.
Sequence Stan	The following standard types are available for selection: NeeS Paper
Attribute	Description
dard Type	eCTD 3.2 eCTD 4.0 If there is no eCTD 4.0 type, eCTD 3.2 is selected by default. If there is at least one eCTD 4.0 Sequence under the Application,eCTD 4.0 is selected by default.
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.