Table of Contents

• Title and Copyright Information
• Preface
  • Intended Audience
  • Documentation accessibility
  • Diversity and Inclusion
  • Related resources
  • Access to Oracle Support
• 1 Get started with Oracle Cloud Service Administration
  • About Oracle Argus Cloud Service
  • How Oracle Argus Cloud Service differs from the on-premise version
  • Begin with Oracle Argus Cloud Service subscriptions
  • Components of your Oracle Argus Cloud Service subscription
  • Oracle Argus Cloud Service architecture
  • Get your administrator account credentials
  • What you do as an administrator
  • Sign in for the first time
  • Environments you can access
• 2 Manage sites, groups, and users
  • Manage sites
    • Add user sites
    • User sites fields descriptions
    • Site configuration printout
  • Manage groups
    • Groups included with the Oracle Argus Cloud Service
    • About user groups
    • Add Argus user groups
    • Add local affiliate user groups
    • User groups fields description
    • Users belonging to multiple groups
    • Print a group configuration list
    • Group configuration printout
  • Manage users
    • Create users in Oracle Health Sciences Identity and Access Management Service
    • Add users to Oracle Argus Cloud Service
    • Users fields description
    • Assign OIM roles to Argus users
    • Reset a user password
    • Disable a user in Oracle Health Sciences Identity and Access Management Service
    • Disable a user in Oracle Argus Cloud Service
    • Print a user configuration list
  • Filtering sites, groups and users
    • Applying filters to users and groups
• 3 Manage Argus Advanced Cloud Service
  • Create a new enterprise in Oracle Argus Mart
  • Extract, Transform and Load data (ETL)
    • Run the initial ETL
    • Schedule incremental ETLs
    • Re-initialize the ETL process
  • Replicate your data
  • Grant users with Oracle Argus Analytics access
    • Oracle Analytics Server (OAS) and Oracle Analytics Publisher user types
    • Oracle Analytics Server (OAS) and Oracle Analytics Publisher user roles
    • Oracle Analytics Server (OAS) and Oracle Analytics Publisher users examples
  • About Product Verification Pack (PVP)
    • Obtain a Product Verification Pack
• 4 Manage dictionaries
  • Load Dictionaries
  • Manage dictionaries using the HSGBU Customer Support Portal
    • How to Load Dictionaries
    • Recode Dictionaries
  • Manage dictionaries using the Console self-service options
    • MedDRA dictionaries using the Console self-service options
      • Prerequisites
      • Load a MedDRA or MedDRA J dictionary
      • Overwrite an existing MedDRA or MedDRA J dictionary
      • Recode a MedDRA or MedDRA J dictionary
    • WHODrug dictionaries using the Console self-service options
      • Prerequisites
      • Load a WHODrug dictionary
      • Overwrite an existing WHODrug dictionary
    • J Drug dictionaries using the Console self-service options
      • Prerequisites
      • Load a J Drug dictionary
      • Overwrite an existing J Drug dictionary
  • Frequently asked questions
    • What are the prerequisites to load a dictionary?
    • What are the mandatory files required to be zipped for a successful load?
    • Are there any size restrictions for the dictionary files?
    • Can I upload ZIP files from a remote or shared location?
    • Why are the files zipped?
    • Can I reuse the dictionary files?
    • What is the MDB file?
    • Does each dictionary type need a separate MDB file?
    • From where can I get the MDB files for each dictionary?
    • Do I need to upload the MDB file every load?
    • When do I need to upgrade the MDB file?
    • How do I know if my load is successful?
    • What do I do if the dictionary loading process hangs?
    • How can I load a dictionary in a multi-tenant environment?
    • Can I work on cases or do other activities in Argus when loading a dictionary?
    • Can I upload the same dictionary twice?
    • Where is the dictionary files content stored?
    • In which tablespace is the dictionary schema created? Can it be changed?
    • How do I select the latest loaded dictionary for case coding?
    • Is there a required downtime for MedDRA recode?
    • What are the prerequisites for MedDRA recode?
    • Why is the Update dictionary version for coded terms where existing hierarchy is still current field disabled when View Only is selected?
    • How do I know if the recode is successfully completed?
    • Can older recode logs be downloaded in self-service?
• 5 Use the Argus Cloud Service utilities
  • Data Refresh
  • ESM logs access on sFTP
  • Extensibility and Integrations Framework
  • Gateway Certificate Expiry Alert Notification
  • Monitoring
  • OAM Reports
  • Usage Billing
  • Enterprise Export
• 6 Manage integrations
  • Use the federated identity Single-Sign On (SSO)
    • Enable Federated Identity SSO through SAML 2.0
  • Manage sFTP user access
    • Add an sFTP user
    • Reset an sFTP user password
    • Remove an sFTP user account
  • Set up the VPN tunnel
  • Configure SMTP
• 7 Gateway administration
  • Implement gateway UI access in your Argus Cloud environment
    • Request gateway UI access
    • Grant users with Axway UI access
    • Grant users with Oracle B2B UI access
  • Request creating a trading partner or community from the HSGBU Customer Support Portal
  • Configure Axway B2Bi to transmit reports
    • Before you begin configuring Axway B2Bi
      • Request adding a trading engine node
    • Create a community
    • Add a partner to a community
    • Create application pickups
      • Add an application pickup to a community (all agencies)
      • Add an application pickup to a community for Drugs (FDA)
      • Add an application pickup to a community for Device Reporting (FDA)
      • Add an application pickup to a community for Vaccine (FDA)
    • Specialize collaboration settings
      • Specialize collaboration settings for a partner (FDA)
      • Specialize collaboration settings for a partner (PMDA)
    • Set up application delivery
    • Update the incoming rule for Delivery Settings for each Partner
    • Add a trading pickup to a community
    • Add public URL configuration in trading pickup (Pharma Company URL)
    • Add partner encryption certificate
    • Add partner SSL certificate
    • Add public URL configuration in trading pickup
    • Post-configuration step: Transmit the generated report
    • Typical workflow for transmitting regulatory reports to agencies/partners
• 8 Get support for Oracle Argus Cloud Service
  • What Oracle Support services are available to Argus Cloud Service customers?
  • Work with your CSDM (Cloud Service Delivery Manager)
    • About Cloud Service Delivery Manager (CSDM)
    • CSDM is your single point of contact for Cloud Service support
    • What happens at your regular CSDM Governance call?
    • Your Oracle Argus Cloud Maintenance calendar
    • About change management
  • Use the HSGBU Customer Support Portal to access the Oracle Support Cloud
    • Oracle Argus Cloud Service support overview
    • About support and change request features
    • Register your account
    • Log in to the HSGBU Customer Support Portal
    • About the three types of access to the HSGBU Support Cloud
    • Field entries common to all request types and products
    • Email notifications from the HSGBU Support Cloud
  • You can still use Oracle and third-party consulting services