Event Attributes
Events represent key business objectives or regulatory actions for an Application. The attributes describe the type of Event and the Event details.
| Attribute | Description |
| Action Type | The type of approval required to consider the Event active. |
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Application Code |
The agency-identified Application number (or identifier), which may not be known until submittal time. It may be the same as the internal code. |
| Application Internal Code | The internal code for the Application. This is by default hidden for CTA and IND Applications. |
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Application Name |
The name of the Application that is associated with the Event. |
| Closed | Indicates whether the Event is closed. |
| Copy Default Lead Times from the following Country | When adding an Event-Country, select this option to specify the country whose default lead times you want to apply to the country you are adding. |
| Countries | Countries of the Event.Note: Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Countries multi-select field on the Create Event page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types. |
| CT Shared Data | Clinical Trial shared data associated with an event based on the type of application. This field is available on the Create Event page if the application type is CTA, CTR or IND. |
| Description | Text that describes the Event. |
| EU Grouping/Worksharing |
Used to identify if the Event is part of a Grouping or Worksharing activity for a European variation. Worksharing is used when there is one change to multiple Applications in multiple Procedures. Grouping is used when there are many of the same changes for one Application. |
| Attribute | Description |
| EU Grouping/Worksharing Number | Used to identify the high-level submission number, either a ‘Worksharing’ number or the high-level submission number to be used when grouping Type 1A variations for multiple Marketing Authorizations. |
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Event Add Comment |
Comments you want to share with others in a discussion thread. Will be displayed in the Event Comments box, stamped with the date and time you enter the information and your user ID.Note: The Event Add Comment field is available on the Create/Modify Event Attributes pages only. |
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Event Closed As |
The status to capture how the entities associated with the Event were closed. |
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Event Closed Date |
The date the Event is closed. |
| 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 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. |
| Event Concerned Parties | Concerned Parties are anyone who may be copied on notifications about this entity; use semi-colons (;) to separate e-mail addresses. |
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Event-Country Status |
The current status for the country associated with the Event.When the Event-Country schedule enforces a status progression, only the next status in the progression and optional statuses are available for selection. |
| 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. |
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Timeline/Event Plan Type |
The type of Timeline/Event Plan. The Timeline/Event Plan Type can be Procedure Type, Event Type, or None. When the Timeline/Event Plan Type is Procedure Type, the Timeline/Event Plans available for selection are those associated with the Application Procedure Type. When the Timeline/Event Plan type is Event Type the Timeline/Event Plans available for selection are those associated with the selected Event Type. When the Timeline/Event Plan Type is None, no Timeline/Event Plans will be available for selection. • The Timeline/Event Plan Type is only displayed when an Event is created. |
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Timeline/Event Plan Used |
The Timeline/Event Plan used to create the Event. |
| Attribute | Description |
| Event Type | The type of the Event. |
| Keywords | Words you can use to search for the Event. |
| Procedure Closure Date | The date of the first approval when the RMS approves an Application. |
| Products | The Products associated with the Event. |
| Project Name | The name of the Global Project Planning (GPP) project with which this Event is associated. |
| PSUR Flag | Indicates whether or not there is information associated with the Event to drive the PSUR worldwide report. |
| PSUR Reason/Comment | Identifies the reason for the PSUR filing.Note: If you enter more than 4,000 characters in this field, none of the text is saved when you save changes to the event attributes. |
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PSUR Report Code |
The Code identified in the World Wide PSUR Report. When PSUR flag is set to 'Y', this field is used for the PSUR Report Code. |
| Reason | Reason for creating, modifying or deleting an event. |
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Reason for Comments |
Comments related to reason entered by users. |
| Reason for Termination/Withdrawal | The reason that event was terminated or withdrawn. Appears and is required only when the Event Closed As is set to WITHDRAWN. |
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Reportable in PSUR |
Indicates whether an Event needs to be included in the PSUR. |
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Secondary Event Type |
Used to further define the Event Type. |
| Status Date | The effective date for the current event-country status. |
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Timeline/Event Plan |
A Timeline/Event Plan provides the ability to create an Event-Country Schedule with statuses in the order they are expected to be achieved for a country(s).
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| Attribute | Description |
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| User ID | The user name to validate user identity. |
| Password | The user password to validate user identity. |
| Variation Number | The regulatory agency-assigned number that identifies the Event as a variation of a submission. |