EDI Tab Fields

The following table lists and describes the fields on the EDI tab.

Field Purpose

SGML/XML

Enables you to select whether to send the report in SGML or XML format.

Mark as Auto Submit

Enables you to mark the report for auto submission.

Imported Cases are assigned to

Enables you to select the country where imported cases need to be assigned.

Note:

This list contains the configured Oracle Argus Safety sites. The default value is the site of the importing user.

Initial Workflow State

Enables you to configure the initial workflow state for the case.

Note:

This list contains Oracle Argus Safety workflow states. The default value is blank. If you select blank as the workflow state, the system treats the case as a new case being booked-in.

Agency Identifier

Enables you to enter the routing ID configured in Cyclone for the sender community.

Identification Code

Enables you to enter the agency Duns code, a unique code that identifies a trading partner.

Code Qualifier

Enables you to enter the code qualifier. The system uses the code qualifier to interpret the identification code.

XML Source Classification

Defines the E2B source file classification during the E2B import. The system populates this drop-down from the Attachment Classification code list.

Selection Source Classification

Defines the classification of the PDF for initial intake or the difference report during E2B import. The system populates this drop-down from the Attachment Classification code list.

MIR Report Format

Enables you to select MIR report format. This drop-down is applicable only for MIR reports.

For more information, see the Oracle Argus Safety Administrator's Guide.

Message Profile

Enables you to select a message profile.

Message Profile 2

Enables you to select a message profile for Japan elements required for the E2B(R2) profile. This profile is enabled for Oracle Argus Safety Japan users and only when Message Profile is selected as PMDA - I profile.

ACK Profile

Enables you to select the acknowledgement profile.

Primary Receive Agency

Indicates that this is the primary agency receiving E2B reports.

Auto Accept ICSR's

Enables or disables the auto-accept E2Bs for the agency.

Transmit E2B Attachments

Enables or disables transmission of E2B attachments for the agency.

Use Japanese Aware Date for Reporting

Check this check box to use Japanese Aware Date for reporting.

Identification Code

Enables you to enter the company Duns code, a unique code that identifies a trading partner.

Company Identifier

Enables you to enter the company identifier.

Code Qualifier

Enables you to enter the code qualifier. The code qualifier is used to interpret the identification code.

File Name

Enables you to enter the file name

SGML Declaration File

Enables you to enter the SGML Declaration File.

Maximum # of reports to include in the msg

Enables you to enter the maximum number of reports that will be transmitted in one message.

Method

Enables you to select a method. This field contains E2B-EDI Gateway, E2B Physical Media, and E2B-XML Transmission values.

EDI Header Required

Enables you to generate the required EDI Header.

XML Version

Enables you to enter the XML Version.

URL of Message DTD

Enables you to enter the path where the message DTD resides on the Internet or to enter the full path, if it is located on the disk.

Encoding

Enables you to select the character set encoding used in XML

Use Japanese Aware Date for Reporting

Enables you to ensure that reporting is based on the Japanese Aware Date. If this check box is not checked, reporting is based on the English Aware Date.

Allow multiple reports for Marketed Drugs

Check this check box to allow the system to schedule multiple reports for marketed drugs.

Allow multiple reports for Investigational Drugs (Clinical Trial)

Check this check box to allow the system to schedule multiple reports for investigational drugs of the reporting category DA, DB, DC, DD.

Allow multiple reports for Investigational Drugs (Research and Measure)

Check this check box to allow the system to schedule multiple reports for investigational drugs of the reporting category DE, DF, DG.

URL of ACK DTD

Enables you to enter the path where the ACK DTD resides on the Internet or enter the full path, if it is located on the disk.

Note:

In the File Name field, be sure to enter the appropriate naming convention followed by #### before the transmission extension.