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.Parent topic: Configure Regulatory Authorities