14 About dsNavigator

This chapter describes the dsNavigator application and how it interfaces with the centralized MedDRA database for MedDRA coding in the Argus Safety system.

dsNavigator

The centralized coding process is conducted between the following:

• Argus Safety User

• Argus System

• Coding Integration Layer

• dsNavigator Application

• dsNavigator User

dsNavigator Coding Process

The complete coding process can be divided into several steps.

Case Processing - Event Coding Process Flow

This is the first step of the coding process and is initiated as soon as the need for coding an event is determined.

The following event related fields in the case form are eligible for the central coding process:

• Parent Tab - Other Relevant History | Description (Multiple)

• Products Tab - Primary Indications (Multiple)

• Analysis Tab - Company Diagnosis / Syndrome

• Event Tab

  • Description to Reported

  • Description to be Coded

  • Cause of Death (Multiple)

  • Autopsy Results (Multiple)

• Patient Tab

• Other Relevant History - Description (Multiple)

• Lab Test Data (Multiple)

List Maintenance Coding Process Flow

The illustration shows the business process supported by the dsNavigator.

Central Coding Process Management

This process is defined for Argus Safety only. It includes the following:

• Managing Verbatim Modification

• Coding Status Reporting

• Audit Trail

Manage Verbatim Modification

Verbatim as reported in the Argus might change because of the request by the DsNavigator User, Quality Control review, follow up reports or for any other significant business reason. Once the verbatim is modified, the application does the following:

1. Initiates the same process as if a new event or product has been entered

2. Changes the status of the event / product in Argus to "Pending Coding."

The status of the coding has no impact on the process if the previous coding status is in pending and verbatim has been changed

Coding Status Reporting

Argus institutes additional reports to determine the status of the coding with regard to the items sent to the central coding interface, turnaround time and aging of the pending items.

Audit Trail

Argus provides for the logging of the central coding transactions to maintain history of data transfers and to audit changes made to coding records outside of the safety database system.

Configuring through dsNavigator

The following features are available after configuring them through dsNavigator. Click the links to access configuration information

• Central Coding Options

• Coding Review and Coding Status Role

Configuring Central Coding Options

The Administrator can configure central coding options through dsNavigator. The configuration is a one-time process and enables the following:

• Central Coding in the Case Form

• Clicking Encode to send event terms to the central coding interface

Configuring central coding also enables users to make dictionary selections.

Configuring Sections of the Case Form

The Administrator can configure the following sections of the Case Form for Central coding.

Products Tab - Primary Indication

Events Tab - Description to be Coded

Events Tab - Death Details Section

Patient and Parent Tab - Other Relevant History

Analysis Tab - Company Diagnosis

Configuring Encode

The Administrator can configure Encode to enable users to manually send event terms to the central coding interface when they click the button.

Configuring Coding Review and Coding Status Role

The Modify Group screen enables you to configure User Groups to enable access to the coding review screen and coding status screens.

Select the Enabled or Disabled radio button to allow or deny access to users.