Application Maintenance

Application values appear in drop-down lists on the Application Attributes page and are designated at the time an application is created.

Values depend on the country to which the application is being applied. Data administration enables you to add and modify drop-down list values, and set the status of a value to active or inactive. In addition, you can specify an eCTD code, which is used to translate the application type for each country to the eCTD attribute value used for publishing.

When you select a value under Application Maintenance, a page opens with a table of all values that have been defined. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.

The proper data administration access privileges are required to view and modify application maintenance values.

All XEVMPD Data Administration tables provide the ability to configure extra fields. The standard set consists of twenty extra text fields, five extra date fields, and five extra number fields.

All IDMP Data Administration tables provide the ability to add information required to maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data.

Application Maintenance: Application Values

You can create and maintain the following application values:

Age Span Population Attributes

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

Application Category Attributes

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

Application Status Attributes

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

Application Type Attributes

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

Chief Investigator Attributes

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

Country Attributes

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

CTA Product Role Attributes

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

Legal Status Attributes

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

MedDRA Term Attributes

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

Medical Condition Investigated Attributes

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

Medical Product Action/Submission Status Attributes

To define a medical product action/submission status value, enter values for the following attributes:

Medicinal Product Name Part Type Attributes

To define a medicinal product name part type value, enter values for the following attributes:

Medicinal Product Type Values Attributes

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

Procedure Type Attributes

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

Reason for Premature Ending Attributes

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

Region Attributes

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

Region Type Attributes

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

Regulatory Entitlement Status Attributes

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

Regulatory Entitlement Type Attributes

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

Sponsor Type Attributes

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

Trial Design Attributes

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

Trial Phase Attributes

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

Trial Scope Attributes

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

Trial Subject Group Attributes

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

Orphan Status Attributes

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

Chief Investigator Attributes

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

Product Information Document Type Attributes

To define a product information document type value, enter values for the following attributes:

Application Type Conditions

When adding or modifying application types, specific conditions apply.

— Required properties must be completed with valid data.

— Both the application type (abbreviation) and name (application type full name) must be unique within the system.

— Each application type must be associated with one and only one application category. The application category is used to determine application types when creating new application projects in the Global Project Planning (GPP) wizard.

— An application type can be associated with zero, one, or more countries.

— A country can be associated with only one application type per application category. For example, a country cannot be associated with both the MAA and NDA application types for the application category Marketing Authorization.

— An existing application type can be set to active or inactive.

— An application type cannot be set to inactive if that application type is currently the default application type for a country.

— A country cannot be disassociated from an application type if that application type is the default application type for that country.

Country Value Maintenance

A country is associated with an application and is designated at the time an application is created or modified. The table on the Country List page displays ALL countries in the system, and enables you to create or modify the country values that are used in the system.

The proper data administration access privileges are required to view or modify country values.

Using data administration, you can:

— Add new country values to the system

— Modify country values

— Add health authority values to a country

— Associate country with a region

— Add language to the country

— Set the default application type or procedure type for a country

— Set the status of a country to active or inactive

The application created for a country by the Copy Application function will include the default application type and the default procedure type that have been defined for that country.

To set a default application type or default procedure type for a country, the country must first be associated with an application type or procedure type in data administration.

Each country must be associated with a region. The default region for a country is the Rest of World (ROW) region of Regulatory Region type.

To associate country with a region, remove or change the existing associations, the following options can be used:

— County Values (Region tab on the Country Attributes page)

— Region Values (Region Attributes page)

eCTD code and eCTD authority are necessary to add eCTD attributes in the Module 1 administrative metadata automatically. The eCTD attributes are included based on the ICH specification, and are necessary because the country code and agency names may differ between the eCTD and other specifications. This enables the Create eCTD Wizard to identify the correct values from the controlled value lists when there are discrepancies between specifications.

Country Value Conditions

When adding or modifying country values, specific conditions apply.

— Required properties must be populated with valid data.

— Country code and country name must each be unique within the system.

— When creating a country, the default associated region is Rest of World of Regulatory Region type.

— A country can only be associated with one region within a Region Type.

— Modifying a country value will not affect the current region association to the country. — A country value is active upon creation.

— An existing country value can be set to active or inactive.

— Up to one default application type can be set for a country. — Up to one default procedure type can be set for a country.

— Before a procedure type can be set as the default procedure type for a country, the country must be associated with the procedure type in data administration.

— Before an application type can be set as the default application type for a country, the country must be associated with the application type in data administration.

— A procedure type must be active in order to be set as the default procedure type for a country.

— An application type must be active in order to be set as the default application type for a country.

Country Value Attributes

Clicking the Country Values link in Data Administration displays the Country page, which lists all countries currently in the system. You can use the attributes to describe country values associated with an application.

Health Authority Attributes

You can use the attributes to add Health Authority values to a Country in Data Administration.

Country Region Maintenance

You can associate country with a region, disassociate a region to which your country is associated, or modify the country region association from the Country Attributes page.

Note: The Region that belongs to the default region type (Regulatory Region, or IDMP) cannot be disassociated from a country.

To associate, disassociate, or modify a country region association:

1. Choose Go To > Data Administration.
2. Under Application Maintenance, click a link for Country Values.
3. Click a Country Code link to navigate to a needed Country.
4. On the Country attributes page, go to the Region tab:
   • To modify a country region association, go to step 5.
   • To associate a region, go to step 6.
   • To disassociate a region, go step 7.
5. Click the link for the value. Change the Region Type and Region values. Click Save.

   The Region Type field is not available for modifications if the region is of the Regulatory Region or IDMP type.

6. Click Associate/Disassociate Region . Select the Region Type and Region values. Click Save.
7. Select the checkbox for the region you want to disassociate and click Associate/Disassociate Region . On the warning message that appears, click OK.

Note: The region values available for selection are those associated to a selected region type.

Region Attributes

You can use the attributes to associate a Region to your Country on the view Country details page. Required information is indicated by an asterisk (*).

Country Region Maintenance

Associate a language that is used for a Country.

To associate a language to a country:

1. Go To > Data Administration.
2. Under Application Maintenance, click Country Values.
3. Click a Country Code link to navigate to a needed Country.
4. On the Country attributes page, click the Languages tab.
5. Click the Associate/Disassociate Language icon.
6. Select the language.
7. Click Save.

Language Attributes

You can use the attributes to associate a language to a country on the Country attributes page.