Event Maintenance: Event Values

Calyx RIM lets you use Data Administration to add and modify Event values and attributes, and to set statuses on those attributes.

You can create and maintain the following Event values:

Value	Description
Action Type	Approval required before request is considered active, for example, implement without notification, notification after implementation, etc.
EU Grouping or Worksharing	Identifies whether an event is part of a sharing or work group activity.
Event Status	For example, planned, in effect, in discussion, approved, refused, etc. Create event statuses before you create timeline/event plans.
Event Type	Regulatory action for example, original filing, variation type I, variation type II, supplement, etc. Create event types before you create secondary event types. Secondary event types can be associated only with existing event types.
PSUR Report Code	Abbreviation associated with the PSUR being reported on, for example: A = Authorized, AQ = Authorized with Qualifications, LA = Lack of Approval, V = Voluntary Marketing Application Withdrawn by Company, AR = Authorization Renewal
Secondary Event Type	Type of event based on the primary event type, for example, Change to Content of Manufacturing Authorization, Change in Name of Medicinal Product, Change in Name and/or Address of MAH for a primary event of Variation Type I.
Timeline/Event Plan Type	The type of timeline/event plan used to create or update an 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/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 timeline/event plan type can have any sequence of active statuses.
Timeline/Event Plan	An ordered set of milestones that represent the progression of event statuses you expect to occur for an event.

Action Type Attributes

To define an action type value, enter values for the following attributes:

Attribute	Description
Name	The name of the action type. Examples: Notification before Implementation, Implement w/o Notification, Notification after Implementation.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

EU Grouping or Worksharing Attributes

To define a EU grouping or worksharing activity value, enter values for the following attributes:

Attribute	Description
EU Grouping or Worksharing	Values available for selectin to indicate Grouping or Worksharing activities on the Event entity.
Default Flag	Flag to indicate if the value is the default.Yes and No values are available for selection.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Event Status Attributes

To define an event status value, enter values for the following attributes:

Attribute	Description
Name	The name given for the Event Status. Examples: Approved, In Discussion, If Effect, In Review, Planned, Not Approved, Refused, Submitted, Despatched, Data Available, Day 0, Withdrawn.
Default Flag	Flag to indicate if the value is the default.Yes and No values are available for selection.
Internal System Status	The internal status associated to the PDS status. Examples: Submitted, Approved, Not Approved, Day 0, Data Available, Despatched and Withdrawn.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Event Type Attributes

To define an event type value, enter values for the following attributes:

Attribute	Description
Name	The name of the event type. Examples: Original, Supplement, Amendment, Variation I, Variation II, Withdrawal, Annual Report, Resubmission, Pre-submission, Establishment Description Supplement, Efficacy Supplement, Labeling Supplement, CMC Supplement.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

PSUR Report Code Attributes

To define a PSUR report code value, enter values for the following attributes:

Attribute	Description
PSUR Report Code	Code/Abbreviation associated with the PSUR being reported on. Examples: A=Authorized, AQ=Authorized with Qualifications, LA = Lack of Approval, V= Voluntary marketing application withdrawn by company, AR=Authorization Renewal.
PSUR Report Code Name	Full Description of the Report Code.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Secondary Event Type Attributes

To define a secondary event type value, enter values for the following attributes:

Attribute	Description
Name	Secondary Level Events that are based on the Primary Event Type.
Primary Event	Primary Event Types.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Timeline/Event Plan Type Attributes

To define a timeline/event plan type value, enter values for the following attributes:

Attribute	Description
Timeline/Event Plan Type	The type (event type, procedure type or none) that the Timeline/Event Plan is created from. Hyperlinked from the view screen.
Default Flag	Flag to indicate if the value is the default.Yes and No values are available for selection.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Timeline/Event Plan Attributes

To define a timeline/event plan value, enter values for the following attributes:

Attribute	Description
Timeline/Event Plan Type	The type (event type or procedure type) that the Event Plan is created from.
Timeline/Event Plan Name	Name for the Event Plan.
Procedure Type	Procedure Types for which the milestones apply. All active external Procedure Types are available for selection.
Enforce Status Progression	Yes/No drop-down menu that determines if the status for the Event Plan should have progression enforced.
Event Statuses	The milestones/statuses that are applicable.
Optional Event Statuses	These are the optional statuses that the event might progress to that are not planned/expected for the event. Examples: Not Approved, Rejected etc.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.