Calyx RIM Administration

Other Data Maintenance Values

You can create and maintain the following values:
Value Description
Concentration Measure Type Name and code for a relational operator used with a concentration unit to define the concentration of an active ingredient in a pharmaceutical product. For example, if a tablet has 200 milligrams of the active ingredient, the concentration measure type is equal and the concentration unit is milligrams. The list contains the concentration type term names and concentration type codes from the EMA Concentration Types CV. The default value is set to Active. The standard set of extra fields can be configured for this value.
Denominator Unit Name and code that identify a unit of measure, such as milligram, in denominators used to define the strengths of ingredients in medicinal products. The list contains the CV for Denominator Unit. The standard set of extra fields can be configured for this value.
Entity XML/UI Mappings Defines XML mappings for Calyx RIM entity elements.
Warning: Do not deactivate the Entity XML Type Name Package Set Registration. There are Calyx RIM functions and procedures, such as the "Create New Applications - Package Set Registration" Global Project Planning wizard, that rely on this value remaining active.
Home Page Display Properties Used to add or remove shortcuts to wizards and to modify text labels that appear on the Home page. You can enter a maximum of 50 characters for Home Page Title Bars, Menu Bar Display, and I Am Looking To entity labels. You can enter a maximum of 250 characters for Tooltip text.
Indications/Intended Use An indication is a disease or condition for which a drug is approved and for which it is intended to be used. Sub-indication values must exist in the system to be able to associate them with indication/intended use values. The default value is set to Active. The standard set of extra fields can be configured for this value.
Language The two-letter language code ISO 639-1:2002 Alpha-2 is assigned to the language. The default value is set to Active. The standard set of extra fields can be configured for this value.
Legal Basis Assigned name and code for the legal basis of the product. The list contains values for legal basis and codes for the legal basis term/name from the EMA CV. The default value is set to Inactive. The standard set of extra fields can be configured for this value.
Length Unit Of Measure The length can be specified using a numerical value and its unit of measurement.
MAH/Development Sponsor/Organisation Name, address, and other information, including the Organisation Identifier, Location Identifier and Location Status attributes, for marketing holder authorization/development sponsor and organization. The default value is set to Inactive. The standard set of extra fields can be configured for this value.
Note: The following attributes are used to maintain the integration with Organisations management service (OMS) introduced by European Medicines Agency (EMA):
  • MAH/Development Sponsor/Organisation Name
  • Organisation Identifier
  • Address
  • City
  • Post Code
  • Country
  • Location Identifier
  • Location Status
Master File Location (MFL) Name and address information for the master file location company, with EudraVigilance code and comments. The standard set of extra fields can be configured for this value.
Message Sender The unique identifier of an organization that can send information to EudraVigilance. This identifier is assigned when the organization registers with EudraVigilance. The standard set of extra fields can be configured for this value.
Numerator Unit Name and code that identify a unit of measure in numerators used to define the strengths of ingredients in medicinal products. The default value is set to Inactive. The standard set of extra fields can be configured for this value.
Previous EV Code Define previous EV code values to map with new EV codes. The Previous EV Code is assigned to Approved Substance, Pharmaceutical Form, and Route of Administration. The standard set of extra fields can be configured for this value.
Quantity Unit Of Measure Describes the quantity of the pharmaceutical product. It is specified as a value and a unit.
Reason for E-Signature Reasons for changing entities; available when an e-signature is required.
Reason for Termination/Withdrawal Reasons for entity termination or withdrawal. Available for: Application, Product, Event, Sequence, Registration.
SME Status Define values to determine N/A (for non-SMEs), micro, small, and medium companies in correspondence with the quantity of employees, along with their codes. The SME status is required for all updates and inserts of organisations that are Marketing Authorisation Holders. SME Status Name and SME Status Code must be unique in the system. The default value is set to Active. The standard set of extra fields can be configured for this value.
Sub-Indication Used for veterinary products, sub-indication values represent parasites to be associated with an indication. Multiple sub-indications can be associate with an indication, and a sub-indication can be associated with multiple indications.
System Alert Type The System Alert Type allows the user to further define or categorize the System Alert. The System Alert entity provides the ability to create and distribute important messages to Calyx RIM users and groups. System Alerts appear in the Alert Center on the Effective Date set for the Alert. They are displayed for the recipients of the Alert and are removed automatically from the Alert Center on the Expiration Date set for the Alert.
Unit of Measure Prefix Name and code that identify a unit of measure, such as milligram, used to define the strengths of ingredients in medicinal products. The list contains unit of measure prefix values and prefix codes for the unit of measure prefix term/name from the EMA Units of Measure CV. The default value is set to Inactive. The standard set of extra fields can be configured for this value.
Unit of Presentation The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate.
Weight Unit of Measure The weight can be specified using a numerical value and its unit of measurement.

Concentration Measure Type Attributes

To define a concentration measure type value, enter values for the following attributes:

Attribute Description
Concentration Measure Type Name Concentration Measure Type term name. Examples: Equal, Range, Less Than.
Concentration Code Concentration Measure Type Code associated with the Concentration Measure Type Name.
RMS Term Name List of Active Concentration Measure Type RMS Values must be 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.

Denominator Unit Attributes

To define a denominator unit value, enter values for the following attributes:

Attribute Description
Denominator Unit Name Denominator Unit Name assigned by EMA.
Denominator Code Denominator Unit Code assigned by EMA.
RMS Term Name List of Active Denominator/Numerator Unit RMS Values must be 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.

Entity XML UI Mappings Attributes

To define an entity XML UI mappings value, enter values for the following attributes:

Attribute Description
Entity XML Type Name Name of the Product Family Type in InSight.
Associated Entity The entity for which the type is being defined.
Entity XML Type XML Mapping The list of entity types defined in XML.
Default Flag Flag to indicate if the value is the default.Yes and No values are available for selection.
Description Free format text box for entering descriptive information.
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.

Homepage Display Properties Attributes

To define a homepage display properties value, enter values for the following attributes:

Attribute Description
Entity Type Displays a list of entity types in Calyx RIM. The user will have the ability to modify the display properties for the entity type selected.
Name Displays a list of entities for the Entity Type selected.
Display The display value for the entity name selected.
Comments Displays a blank text box to enter comments.
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.

Indications/Intended Use Attributes

To define an indications/intended use value, enter values for the following attributes:

Attribute Description
Indications/Intended Use Name of the Indication or Indication Group - When populated with MedDRA terms, this will be the Preferred Term (PT) from the MedDRA dictionary.
Sub-Indications Sub-indications that belong to a specific indication group. Examples would be parasites such as Fasciola Hepatica, Fasciola Gigantica etc that belong to the Fasciola Hepatica Indication group.
MedDRA Level MedDRA Level: Higher Level Group Term (HLGT), Higher Level Term (HLT), Lower Level Class (LLT), Preferred Term (PT), System Organ Class (SOC).
MeDRA Code This field should have correct value depending on MeDRA Level value selected.
Note: one of three following fields Indications/Intended Use, MedDRA Level, MedDRA Code should be unique in the system.
MedDRA Term Version When populated with MedDRA terms this is the version where the term can be found.
MedDRA Term Last Updated Last time the Medra Term was updated auto populated by system.
Description Free format text box for entering descriptive information.
Comments Free format text box where users can enter information.
Keywords Free format text box where users can enter text for searching purposes.
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.

Language Attributes

To define a language value, enter values for the following attributes:

Attribute Description
Language Name Name of the Language.
Language Code 2-letter language code assigned to language ISO.
ISO ALPHA-3 CODE 3-letter language code assigned to language.
RMS Term Name List of Active Language RMS Values must be 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.

Legal Basis Attributes

To define a legal basis value, enter values for the following attributes:

Attribute Description
Legal Basis Name Legal Basis term.
Legal Basis Code Code assigned to the Legal Basis value.
RMS Term Name List of Active Language RMS Values must be 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.

Length Unit Of Measure Attributes

To define a length unit of measure value, enter values for the following attributes:

Attribute Description
Code Value The actual value for the code.
Code Name The full name and/or description for the 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.

MAH/Development Sponsor/Organisation Attributes

To define a MAH/Development Sponsor/Organisation value, enter values for the following attributes:

Attribute Description
MAH/Development Sponsor/Organisation Name Name of the Marketing Authorization Holder or Sponsor.
Organisation Identifier Organisation Identifier so that RIM code could be mapped to the IDMP code.
Address MAH/Sponsor address line.
City MAH/Sponsor city.
Region MAH/Sponsor state.
Post Code MAH/Sponsor post code.
Country MAH/Sponsor country name.
Telephone Number MAH/Sponsor telephone number.
Telephone Extension MAH/Sponsor telephone extension.
Telephone Country Code MAH/Sponsor telephone country code.
Fax Number MAH/Sponsor fax number.
Fax Extension MAH/Sponsor fax extension.
Fax Country Code MAH/Sponsor fax country code.
E-Mail Address MAH/Sponsor E-Mail address
Is Company Responsible for XEVMPD Is used in the XEVMPD Wizard to help in selecting only records that the company is responsible for sending.
Organisation Sender ID Organization Sender ID
Location Identifier Location Identifier.
Location Status Location Status. Predefined values: [Select], Active, Inactive.
SME Status SME Status.
SME Number SME number of the organisation where applicable.
Comments Comments
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.

Master File Location (MFL) Attributes

To define a master file location value, enter values for the following attributes:

Attribute Description
MFL Company Name of the company that holds the Pharmacovigilance System Master File (PSMF). MFL is currently optional by EMA, but if the MFL used, schema will require associated fields.
Department Name of the department that holds the PSMF.
Building Building part of the address.
Street Street part of the address.
City City part of the address must be specified.
State State part of the address
Post Code Post Code (ZIP) part of the address must be specified.
Country All active Country codes from the Country Values pick list are available for selection.
Note: one of following listed fields: MFL Company,Street,City,Post Code,Country,Department,Building should be unique in the system.
Date Submitted to EMA Date Submitted to EMA. It will be populated automatically when Acknowledgement Wizard is passed.
EV Code Official EV Code assigned by the EMA.
XEVMPD Comments Comments field. Comments are required for nullification.
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 Updated 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.

Message Sender Attributes

To define a message sender value, enter values for the following attributes:

Attribute Description
Message Sender Name Name of the Sender associated with the XML file created. Should be unique in the system.
Message Sender ID Unique identifier of the sender organisation as assigned during the EudraVigilance registration process. This ID is used in the XML. This ID is used in the XML and is constrained for use on Marketing Auth (License) instead of the Organisation Sender ID, although they are likely the same. Should be unique in the system.
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.

Numerator Unit Attributes

To define a numerator unit value, enter values for the following attributes:

Attribute Description
Numerator Unit Name Name of the Sender associated with the XML file created. Should be unique in the system.Long Version of the Unit Measure name of the AI, Excipients, Adjuvants. Examples of short names to long names:%w/v=%wt/volume, etc Value taken from the OOTB pick list Substance Numerator Unit Values published by EMA. Should be unique in the system.
Numerator Code Short Version of the Unit Measure name of the AI, Excipients, Adjuvants. Examples: % w/v, etc. Value taken from the OOTB pick list Substance Numerator Unit Values published by EMA. Should be unique in the system.
RMS Term Name List of Active Denominator/Numerator Unit RMS Values 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.

Previous EV Code Attributes

To define a previous EV Code value, enter values for the following attributes:

Attribute Description
Previous EV Code Value of previous EV Code.
Code Type Code Type. Examples: Select, Approved Substance, Pharmaceutical Form, Route of Administration.
Comments Comments to the value.
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.

Quantity Unit Of Measure Attributes

To define a quantity unit of measure value, enter values for the following attributes:

Attribute Description
Code Value The actual value for the code.
Code Name The full name and/or description for the 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.

Reason for E-Signature Attributes

To define a reason for E-Signature value, enter values for the following attributes:

Attribute Description
Reason for E-Signature Reason for making a modification on an entity. Examples: Status Update, Error correction, Date Correction.
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.

Reasons for Termination/Withdrawal Attributes

To define a reason for termination/withdrawal value, enter values for the following attributes:

Attribute Description
Reasons for Termination/Withdrawal Reason for termination or withdrawal an entity. Applicable for: Application, Product, Event, Sequence, Registration (both 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.

SME Status Attributes

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

Attribute Description
SME Status Name SME Status Name.
SME Status Code SME Status 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.

Sub-Indication Attributes

To define a sub-indication value, enter values for the following attributes:

Attribute Description
Sub-Indication Sub-Indication.
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.

System Alert Type Attributes

To define a system alert type value, enter values for the following attributes:

Attribute Description
Alert Type The Alert Type allows the user to further define or categorize the System Alert entity.
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.

Unit of Measure Prefix Attributes

To define a unit of measure prefix value, enter values for the following attributes:

Attribute Description
Unit of Measure Prefix Name The System Alert Type allows the user to further define or categorize the System Alert entity.
Prefix Code Code assigned to the Unit of Measure prefix. Should be unique in the system.
RMS Term Name List of Active Unit of Measure Prefix RMS 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.

Unit Of Presentation Attributes

To define a unit of presentation value, enter values for the following attributes:

Attribute Description
Code Value The actual value for the code.
Code Name The full name and/or description for the 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.

Weight Unit Of Measure Attributes

To define a weight unit of measure value, enter values for the following attributes:

Attribute Description
Code Value The actual value for the code.
Code Name The full name and/or description for the 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.