MEDDRA_Response

Oracle Argus Safety expects the central MedDRA dictionary to send the response in this format.

  • Schema File

    Version 1.0

    Top level file: \v1.0\MedDRA_Response.xsd

    Sublevel file: \v1.0\Base.xsd

    Version 1.1

    Top level file: \v1.1\MedDRA_Response.xsd

    Version 2.0

    Top level file: \v2.0\MedDRA_Response.xsd

  • Namespace

    http://www.oracle.com/Argus/MedDRA_Response/v1.0

    http://www.oracle.com/Argus/MedDRA_Response/v1.1

    http://www.oracle.com/Argus/MedDRA_Response/v2.0

  • Node/Attribute Name Description
Node/Attribute Name Description

Action

Must have the value Auto.

This attribute must be present in the request when a full hierarchy is required to be passed back to auto encode the term without using the MedDRA Browser. With an "Auto" message, the system requires that an LLT Term be passed in the request. If the full hierarchy is not found or returned, the system will open the MedDRA Browser and display the LLTs returned for manual encoding by the user using the local MedDRA instance. If multiple paths are returned, the Primary SOC path is used.

Source

An enumerated value that specifies additional information that may be required for coding based on origination as follows:

  • Reaction

    Case Form | Patient Tab | Patient Tab | Other Relevant History | ReactionCase Form | Patient Tab | Parent Tab | Other Relevant History | Reaction

  • Indication

    Case Form | Patient Tab | Patient Tab | Other Relevant History | IndicationCase Form | Patient Tab | Parent Tab | Other Relevant History | Indication

  • Condition should be verbatim

    Case Form | Patient Tab | Patient Tab | Other Relevant History | VerbatimCase Form | Patient Tab | Parent Tab | Other Relevant History | Verbatim

  • Lab

    Console | Code Lists | Lab Test Type

  • Description

    Case Form | Events Tab | Event Tab | Description to be CodedCase Form | Events Tab | Death Information | Cause of Death and Autopsy Results | Description as Reported

  • Diagnosis

    Argus Case Form | Analysis Tab | Analysis Tab| Company Diagnosis Syndrome

Term

(v 1.0)

The TERM node specifies the information about a specific term that is either being looked up or populated with data and supports Reported and Coded nodes.

Term

(v 1.1/2.0)

The TERM node specifies the information about a specific term that is either being looked up or populated with data and supports Reported, Coded, and Lang nodes.

Primary

The Primary attribute is Y if the term is the Primary SOC path for the selected term. In the event that multiple terms are returned for a MedDRA level, this attribute is only be available on the primary term.

PATHS/PATH

(version 1.0)

The PATHS node has a PATH subnode for each MedDRA hierarchy returned. MedDRA hierarchy with English terms only.

PATHS/PATH

(version 1.1)

Contains MedDRA hierarchy with English and Japanese terms (without support for the J term currency detail).

PATHS/PATH

(version 2.0)

Contains MedDRA hierarchy with English and Japanese terms (with support for the J term currency detail) for the LLT term.