Common Profile Switches for E2B

The following screen is displayed when you navigate to Common Profile > Argus J > E2B:

E2B Common Profile Switches screen

The following table explains the fields used in the screen:

Field Name Description Field Options

E2B filename extension for Interchange -J

This field represents the E2B filename extension for ESM-J

Default Value: SGM

SGM

Drug assessment source for reported causality (used by E2B/Interchange-J module)

This function for the B.4.k.18.2 is different from EMEA rule, as in EMEA these values are hardcoded in the application while in PMDA they come from the CMN_Profile switch.

Field Length: 120JAudit Log: Yes

Drug assessment source for determined causality (used by E2B/Interchange-J module)

This function for the B.4.k.18.2 is different from EMEA rule, as in EMEA these values are hardcoded in the application while in PMDA they come from the CMN_Profile switch.

Field Length: 120JAudit Log: Yes

Drug assessment method (used by E2B/Interchange-J module)

The field value chosen in the Case Form > Event Assessment tab is populated for B.4.k.18.3 DRUGASSESSMENTMETHOD field for the Product Event combination selection for E2B report mapping. If you have the Drug Assessment Method field hidden for the Case Form, the value for B.4.k.18.3 DRUGASSESSMENTMETHOD is set to the value in this field by default.

Field Length: 70JAudit Log: Yes

File attachments allowed for PMDA E2B R3 Profile

This Common Profile Switch checks the allowed files that can be attached in the E2B (R3) report generated using PMDA profile.

Pdf, jpeg, jpg, bmp, png, gif, tif, tiff, rtf, txt, xls, xlsx, doc, docx, xml, html, and dicom

Dummy Reaction for Research & Measure Report (R3)

New Enterprise level profile switch is added in the Oracle Argus Safety Console to configure the Dummy Reaction.

A dummy event is created in the case. If the event exits in the report use that event. Else if no event exists then use this dummy event of a PMDA R3 report of research and measure category ('E', 'F', 'G', 'L', 'M', 'N', 'O', 'P'). Also the exclusions for the same are done in the Minimum case validation for these reporting categories.

Note: If E.i.1.2 is available and E.i.2.1b is not available in the E2B element then encode the Reaction using E.i.1.2 Tag value (Primary Source Path). Refer to the Mapping Document for details.

This dummy event is visible in the Pending screen and also listed in the Difference Report Viewer.

Note: PMDA E2B R3 import logic is implemented based on the Import framework to support EMA R3 import. Hence all the framework level concepts applies to PMDA E2B R3 import as well. Refer Oracle Argus Interchange User's Guide for details of the framework.

Text: 255(max length)

Default value: Dummy Reaction

Compression algorithm for file attachments in PMDA E2B R3

This Common Profile Switch specifies the compression algorithm for the attachments in E2B (R3) report generated using PMDA profile.

DF (default selected)

GZIP

Seriousness criteria in Event Reportability Matrix

The Event Reportability algorithm used by the PMDA E2B and Paper Reports considers seriousness criteria value as Case Level or Event Level seriousness based on the value set for this common profile switch.

Default Value: Event Level Seriousness

Case Level Seriousness

Event Level Seriousness