Calyx RIM Administration

Submission Maintenance: Submission Values

The following submission values can be created and maintained under Submission Maintenance:
Value Description
Applicant Contact Type The applicant contact types that match the codes that the regulatory agency provides.
Applicant Contact All active applicant contact values.
Applicant ID The applicant ID.
Application Form Type The application form types that match the codes that the regulatory agency provides.
Drug Registration File Documents Section The values that EAEU defines to describe a drug registration file documents section.
Drug Registration File Documents The values that EAEU defines to describe a drug registration file documents.
Font Definition The fonts that you can use in tab sheets created in Calyx RIM Publisher. Refer to the Font Definition Attributes table below.
Leaf Status The status that can be assigned to a leaf. When assigned, helps to identify the leafs in an assembly that need to be published or have already been published. Three "out-of-the-box" statuses are provided:
  • Planned
  • Ready for Publish
  • Published
Default value is Planned. Refer to the Leaf Status Attributes table below.
PDF Properties The PDF properties that you can use in Leaf Elements and Publishing Settings Library. Refer to the PDF Properties Attributes table below.
Promotional Material Audience Type The promotional material audience types that match the code that the regulatory agency provides.
Promotional Material Doc Type The promotional material doc types that match the codes that the regulatory agency provides.
Promotional Material Type The promotional material types that match the codes that the regulatory agency provides.
Regulatory Activity Lead Health Canada groups that can take the lead in reviewing the regulatory activity that a regulatory transaction supports.
Sequence Description The values that Health Canada defines to describe a sequence (regulatory transaction).
Submission Product Type The values that describe a submission product type as defined by the China region.
Sub Filing Type The sub filing types that match the codes that the regulatory agency provides.
Supplement Effective Date Type The supplement effective date types that match the codes that the regulatory agency provides.
Telephone Number Type The telephone number types that match the codes that the regulatory agency provides.

Applicant Contact Type Attributes

To define an applicant contact type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by the Regulatory Agency.
Applicant Contact Type Applicant Contact Type name matching the code provided by the agency.
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.

Applicant Contact Attributes

To define an applicant contact, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Applicant Contact Name Name of the Applicant Contact.
Applicant Contact Type All active values from the Applicant Contact Type Values.
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.

Applicant ID Attributes

To define an applicant ID, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Applicant ID Format The format for the Applicant ID. Allowed values: DUNS.
Applicant Name Applicant Name matching the Applicant ID.
Applicant ID Applicant ID must be unique within the region.
Default for Region Yes and No values are available for selection to indicate if the region is the default or not.
Note: Only one region can have the default flag set to Yes within the system. When you change the region to the default, the previously defaulted entity is automatically updated to have the default flag set to No.
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.

Application Form Type Attributes

To define an application form type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by the Regulatory Agency.
Application Form Type Application Form Type name matching the code provided by the agency.
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.

Drug Registration File Documents Section Values

To define a drug registration file documents section, enter values for the following attributes:

Attribute Description
Section Code Section code provided by agency.
Name Name provided by agency.
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.

Drug Registration File Document Values

To define a drug registration file document, enter values for the following attributes:

Attribute Description
Section Section code provided by agency. All active values of Section Code from the Drug Registration File Documents Section Values are available for selection.
Document Code Document code provided by agency.
Name Name provided by agency.
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.

Font Definition Attributes

To define a font, enter values for the following attributes:

Attribute Description
Font Display Name The font name that appears on the Tab Sheet Attributes page.
Font Name Must match the font name on the Calyx RIM Rendering server.
Font Code Used when an assembly with tab settings is exported from or imported into Calyx RIM.
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.

Leaf Status Attributes

To define a leaf status, enter values for the following attributes:

Attribute Description
Leaf Status Name The leaf status name that appears in Leaf Elements. The name must be unique within the system.
Default Flag Yes and No values are available for selection to indicate if the leaf status is the default or not.
Note: Only one leaf status can have the default flag set to Yes within the system. When you change leaf status to the default, the previously defaulted entity is automatically updated to have the default flag set to No.
Internal System Status The internal system status to associate to the leaf status. The values available for selection are PLANNED, NOT APPROVED, and PUBLISHED. Or, you can leave the field blank.
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.

PDF Properties Attributes

To define a PDF property, enter values for the following attributes:

Attribute Description
PDF Property Name The PDF property name that appears in Leaf Elements and Publishing Settings Library.
Source Property Yes and No values are available for selection to indicate if the property is a source or not.
Target Property Yes and No values are available for selection to indicate if the property is a target or not.
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.

Promotional Material Audience Type Attributes

To define a promotional material audience type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by agency.
Promotional Material Audience Type Promotional Material Audience Type name matching the code provided by the agency.
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.

Promotional Material Doc Type Attributes

To define a promotional material doc type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by agency.
Promotional Material Doc Type Promotional Material Doc Type name matching the code provided by the agency.
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.

Promotional Material Type Attributes

To define a promotional material type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by agency.
Promotional Material Type Promotional Material Type matching the code provided by the agency.
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.

Regulatory Activity Lead Attributes

To define a regulatory activity lead, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
eCTD Code The regulatory code from the controlled vocabulary provided by the agency.
Regulatory Activity Lead The regulatory activity lead which corresponds to the eCTD code.
Applicable DTD/Schema All active DTD/Schemas from the Assembly DTD/Schema Types limited by the selected Region.
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.

Submission Product Type Attributes

To define a submission product type, enter values for the following attributes:

Attribute Description
Region Region value for Submission Product Type. All active values of Regulatory Region type from the Region Values are available for selection.
eCTD Code eCTD Code provided by agency.
Product Type Description of Product Type. Allowed values:Chemical Product or Biological Product .
Applicable DTD/Schema List of DTD names filtered out by selected region.
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.

Sequence Description Attributes

To define a sequence description, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
eCTD Code The regulatory code from the controlled vocabulary provided by the agency. Combination of DTD/Schema and eCTD Code must be unique.
Sequence Description The submission description which corresponds to the regulatory code.
Sequence Description Additional Data Type The type of additional data (variables) that can be used in the description. Values available for selection are: Text, Date Range, Date, Number and Date.
Applicable DTD/Schema All active DTD/Schemas from the Assembly DTD/Schema Types limited by the selected Region.
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.

Sub Filing Type Attributes

To define a sub filing type, enter values for the following attributes:

Attribute Description
Sub Filing Type Sub Filing Type matching the code provided by the agency. Sub Filing Type must be unique.
Countries Countries that are applicable to this sub type.
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.

Supplement Effective Date Type Attributes

To define a supplement effective date type, enter values for the following attributes:

Attribute Description
Supplement Effective Date Type Name Supplement Date Effective Type name matching the code provided by the agency.
Countries A list of all countries that this effective date type applies to.
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.

Telephone Number Type Attributes

To define a telephone number type, enter values for the following attributes:

Attribute Description
Region All active values of Regulatory Region type from the Region Values are available for selection.
Regulatory Code Regulatory Code provided by the Regulatory Agency.
Telephone Number Type Telephone Number Type name matching the code provided by the agency.
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.