Calyx RIM Administration

Application Maintenance: Application Values

Create and maintain the application values and attributes described in the tables below.

Value Description
Age Span Population Ages of those being tested in a trial, such as in utero, infant, adolescent, etc.
Application Category Groupings for similar application types used in Global Project Planning (GPP). For example: by default, Calyx RIM associates the Clinical Trial category to the application types IND (US) and CTA (EU).  When you use the Clinical Trial category with the GPP wizard, an IND for the US and a CTA for the EU are created.
Application Status For example: as planned, approved, withdrawn.
Application Type For example: name and the countries associated with the type.
Chief Investigator People who are responsible for the design, conduct, analysis, and reporting of clinical trial information.
Country Add new country values to the system, modify country values, associate a country with a region, set the default application type or procedure type for a country, and set the active or inactive status for a country. MRP/CP countries (other than reviewing country/rapporteur/co-rapporteur) can have twenty extra text fields, five extra date fields, and five extra number fields configured.
CTA Product Role The roles a product plays in a trial, such as IMP, comparator, and placebo.
Legal Status For example: pharmacy only medicine, prescription only, over the counter.
MedDRA Term MedDRA version, level, and classification code for a trial.
Medical Condition Investigated Condition being investigated by the trial.
Procedure Type Internally mapped to one of the following: CP, DCP, MRP, or National. The list contains the XEVMPD term ID from the Authorisation Procedures CV for the procedure type. The default value is set to Active. The standard set of extra fields can be configured for this value.
Note: Changing the MRP (Mutual Recognition) or CP (Centralized Procedure) procedure type values is not recommended. Specific business logic is associated with these procedure types and may result in unexpected results if you change the values.
Note: If this is a Calyx RIM D2 integrated system, one the following values must be present in order for D2 to recognize the procedure type correctly:
  • Centralized or CP
  • Decentralized or DCP
  • Mutual Recognition Procedure or MRP
  • National
Reason for Premature Ending For example: safety, lack of efficacy, trial never commenced, etc.
Region Regions with which the countries are associated, for example: EU, SA, AS, etc. Can have twenty extra text fields, five extra date fields, and five extra number fields configured. You must select a region type for a region you are creating. To add a region, you enter values for the attributes displayed in the Region Attributes table below.
Region Type Type of a region. The name of a region type must be unique within the system. Example: Regulatory Region. You can enter up to 200 characters for the Region Type value. The default value is set to Active.
The Regulatory Region and IDMP types exist in the system by default. Both values are not available for modifications and cannot be deactivated. You can:
  • Update the list of countries that are associated to the region of a regulatory region type, or create a new region of a regulatory region type using the Region Values section.
  • Update the list of countries that are associated to the region of an IDMP type, or Create a new region of an IDMP type using the Region Values section.
Sponsor Type Trial sponsor, for example: commercial or noncommercial.
Trial Design For example: randomized, open, single blind, double blind, parallel group, cross over.
Trial Phase For example: phase I, phase II, phase III, etc.
Trial Scope For example: diagnosis, prophylaxis, therapy, safety, efficacy, pharmacokinetic, or pharmacodynamic.
Trial Subject Groups For example: healthy, patients, women-child bearing potential, woman-child bearing potential on contraceptives, pregnant, nursing, emergency situation, incapable of giving consent, etc.

Age Span Population Attributes

To define an age span population value, enter values for the following attributes:

Attribute Description
Age Span Population Value Values are: In Utero, Preterm newborn, newborn, infant and toddler, children, adolescent, adult, elderly.
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 Category Attributes

To define an application category value, enter values for the following attributes:

Attribute Description
Application Category Name Name of the application category. Examples: Clinical Trials, Marketing Application.
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 Status Attributes

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

Attribute Description
Name The name given for the Application status.
Default Flag Flag to indicate if the product status is the default.Yes and No values are available for selection.
System Process Default Flag Enables you to select which status will show for an Application after the Event is closed.
Internal System Status The internal status associated to the product status. Planned, Submitted, Approved, Not Approved values and Withdrawn 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.

Application Type Attributes

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

Attribute Description
Application Type Abbreviation for the Application Type. Example: NDA.
Name Full Application Type Name. Example: New Drug Application.
Display Name Display Name.
Entity XML Type Name Entity XML Type Name. All the xml mappings defined for the application entity are available for selection.
Application Category Application Category that the Application Type is mapped to. All active Application Categories defined in the system are available for selection.
Countries Countries.
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.

Chief Investigator Attributes

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

Attribute Description
Chief Investigator Values Person responsible for the design, conduct, analysis and reporting of the clinical trial 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.

Country Attributes

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

Attribute Description
Country Code 2-digit country code as defined by ISO. Example: UK, DE, US, etc.
Country Name Full Country Name. Example: United Kingdom, Germany, United States, etc.
eCTD Code eCTD Code.
RMS Term Name List of Active Country RMS Values must be available for selection. Data will be available in the concatenation, separated by space: Term Name + Term Identifier.
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.

CTA Product Role Attributes

To define a CTA product role value, enter values for the following attributes:

Attribute Description
CTA Product Role Values *CTA Only - values are: IMP, comparator, and placebo.
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 Status Attributes

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

Attribute Description
Legal Status Value Abbreviation for the Legal Status Name. Example: POM, Rx, OTC.
Name The full name of the Legal Status. Examples: Pharmacy Only Medicine, Prescription Only, Over the Counter.
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.

MedDRA Term Attributes

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

Attribute Description
MedDRA Term Values MedDRA version, level, term and classification 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.

Medical Condition Investigated Attributes

To define a medical condition investigated value, enter values for the following attributes:

Attribute Description
Medical Condition Investigated Values Medical Condition being investigated.
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.

Procedure Type Attributes

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

Attribute Description
Procedure Type Abbreviation Abbreviation for the Procedure Type. Example: MRP.
Procedure Type Name Full Procedure Type Name. Example: Mutual Recognition Procedure.
Display Name Display Name.
Internal Procedure Code Procedure types that identify what business rules will be applied when selecting the User Facing Procedure Types on an Application. Because they are used internally, they are not configurable by a user.
eCTD Code eCTD Code.
Procedure Type Code Current codes according to the EMA Authorisatin Procedure CV.
Note: Procedure Type Abbreviation and Procedure Type Name should be unique to accept within following ligament Procedure Type Abbreviation,Procedure Type Name,Display Name, Internal Procedure Code.
External System Procedure Type Code External system procedure type code.
Countries Identifies the countries for which the Procedure Type is valid.
RMS Term Name List of Active Procedure 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.

Reason for Premature Ending Attributes

To define a reason for premature ending value, enter values for the following attributes:

Attribute Description
Reason for Premature Ending Values Values are: Safety, Lack of efficacy, trial never commenced; other.
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.

Region Attributes

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

Attribute Description
Region Type The Type of Region, from Region Type values.
Region Abbreviation An abbreviation of 1-5 characters for a region you are creating. Example: EU.The value you are entering must be unique within the system.
Region Name A full name of a region. Example: European Union . The name you are entering must be unique within a Region Type.
Countries Countries associated to a region. A country can only belong to one region within the Region 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.

Region Type Attributes

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

Attribute Description
Region Type Name The name of the Region Type to be used. The value you are entering must be unique within 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.

Sponsor Type Attributes

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

Attribute Description
Sponsor Type Sponsor Type. Values are: Commercial and Non-Commercial.
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.

Trial Design Attributes

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

Attribute Description
Trial Design Values Trial Design. Values are: Randomized, Open, Single Blind, Double Blind, Parallel Group, Cross Over
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.

Trial Phase Attributes

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

Attribute Description
Trial Phase Values Phases in a clincial trial. Values are: Phase I, Phase II, Phase III, Phase IV.
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.

Trial Scope Attributes

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

Attribute Description
Trial Scope Values Values are: Diagnosis, Prophylaxis, Therapy, Safety, Efficacy, Pharmacokinetic, Pharmacodynamic, Bioequivalence, Dose Response, Pharmacogeneic, Pharmacogenomic, Pharmacoeconomic.
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.

Trial Subject Group Attributes

To define a trial subject group value, enter values for the following attributes:

Attribute Description
Trial Subject Group Values Values are: Healthy, Patients, women-child bearing potential, woman-child bearing potential on contraceptives, pregnant, nursing, emergency situation, incapable of giving consent.
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.