1. Japan User's Guide
  2. Configure Oracle Argus Interchange
  3. Oracle Argus Interchange Mapping Utility

Oracle Argus Interchange Mapping Utility

Oracle Argus Interchange mapping utility enables you to configure the Oracle Argus Interchange Service.

  • Provides a framework that allows you to configure conformance rules (validations against the ICSR reporting profiles: ICH, EMA, eVAERS and PMDA) based on the individual E2B (R3) Profiles.
  • You can configure parameters for each ICSR Element Node for which data is transmitted.
  • The Conformance Rules tab data is copied to the new profile when you copy any existing ICSR profile.
  • The following table list the fields available in the Conformance Rules tab:

    Table 2-1 Fields in the Conformance Rules tab

    # Field Name Type Description

    1

    Field Name/ Field Name (J)

    Textbox

    Enter the Field Name or Label of the Case Form or Console UI corresponding to the element's mapping logic.

    • ICH, EMA, and eVAERS: English
    • PMDA: Japanese
    • PMDA E2B R3: See Mapping xls'Mapping(Sheet) > UI Field Name(J)

    2

    Field Location

    Textbox

    Enter the Case Form or Console UI field location or path corresponding to the element's mapping logic.

    • ICH, EMA, and eVAERS: English
    • PMDA: Japanese
    • PMDA E2B R3: See Mapping xls'Mapping(Sheet) > UI Field Name(J)

    3

    Data Type

    Drop Down

    Select from the following options:

    • <blank> (Default)
    • Text
    • E2B Code
    • Country
    • Date/Time
    • MedDRA Version
    • MedDRA Term/Code
    • PMDA E2B R3: See Mapping xls > Mapping(Sheet) > PMDA Data Type DTD R3

    4

    Data Length

    Textbox

    Enter a numeric value.For PMDA E2B R3: See Mapping xls > Mapping(Sheet) > PMDA Length DTD R3

    5

    Mandatory Along with

    Dropdown

    Select a DTD_ELEMENT name from the list of all the elements available from the same parent of the selected element (except the selected element itself). Default value is <blank>.

    For PMDA E2B R3: See Mapping xls > Mapping(Sheet) > Mandatory Along with

    6

    Allowed Value Check Required

    Checkbox

    Unchecked by default.For PMDA E2B (R3): See Mapping xls > Mapping(Sheet) > Allowed Values

    7

    Allowed Values

    Button

    On Clicking this button, "Allowed value configuration" dialog box appears to configuring the allowed values for the selected elements for that profile.

    This button is enabled only if "Allowed Value Check Required" checkbox is selected.

    For PMDA E2B (R3): See Mapping xls > Mapping(Sheet) > Allowed Values

    8

    Primary Validation Category

    Drop Down

    This option is available only for ICH, EMA, and eVAERS profile.This drop-down list has the values:

    • <blank> (Default)
    • Mandatory
    • Conditional Mandatory
    • Optional
    • Other Fatal Validation
    • Do not enter

    9

    Additional Validations

    Button

    On clicking this button, the "Additional Validation Configuration" dialog box appears that enables you to configure the SQL based validations for the element.This button is available only for ICH, EMA, and eVAERS.

    10.1-10.4

    --

    --

    See separate table below

    11

    Save

    Button

    On clicking the save button the changes are committed to the database and the audit logs.

    Saving the data also includes any changes done in the Allowed Value Configuration and Additional Validation Configuration dialog boxes.

    It also validates if a Primary category exists for the ICSR element.

    • For Non-PMDA profile: Element Level
    • For PMDA profile: Reporting Category Level

    If there exists a row with primary category as blank, an error message is displayed:

    "Please select a Primary Validation category for the element" Title: "ICSR Validation"

    12

    Print

    Button

    On clicking the print button, entire Conformance Rule tab data is printed.

    Table 2-2 PMDA Specific Fields in the Conformance Rules tab

    # Field Name Type Description

    10.1

    Reporting Category

    Label

    This field represents a drop-down list containing Reporting Category LM. This is a mandatory field.

    Determines the report being created (ADR, Infection, Research, or Measures in foreign countries). The list values are determined at run time by the values selected in items 9,10, and 12.

    When Reporting Category is not selected, the license does not create the report.All the Reporting Category (R3) Codes (AA,AB,AC,AD,AE,AF,AG,DA,DB,DC,DD,DE,DF,DG,BC,BD) as configured in the Reporting Category (flex code list) are listed here, along with Nullification.

    10.2

    Reporting Category Description

    Label

    Describes the corresponding Reporting Category.

    10.3

    Primary Validation Category

    Drop Down

    This dropdown is available for PMDA profile only.

    This field has the values:

    • <blank> (Default)
    • Mandatory
    • Conditional Mandatory
    • Mandatory for Completion Report
    • Conditional Mandatory for Completion Report
    • Optional
    • Do not Enter
    • Other Fatal Validation

    For PMDA E2B (R3): See Mapping xls > Mapping(Sheet) > Reporting Category wise Conformance

    10.4

    		 Additional Validations

    Button

    On clicking this button, the "Additional Validation Configuration" dialog box appears that enables you to configure the SQL based validations for the element.

    This button is available against each Reporting Category.

Note:

Most features of the Interchange have been moved to the web-based console.

For more information, see:

Parent topic: Configure Oracle Argus Interchange