1. Introduction to Oracle Argus

• Overview of Argus: Understanding the platform, architecture, and primary functionalities.
• Pharmacovigilance Concepts: Basics of pharmacovigilance, the role of drug safety, and the importance of adverse event (AE) reporting.
• Key Features: Introduction to case management, regulatory compliance, reporting, and signal detection.

2. Argus User Interface

• Navigating the Argus Interface: Understanding the dashboard, menus, and common workflow paths.
• Customizing User Profiles: Setting up user preferences, notifications, and roles.
• System Settings and Configurations: Overview of system configuration options and settings.

3. Case Management

• Creating and Managing Cases:
  • How to enter new cases, including adverse events and patient data.
  • Handling data entry for adverse event (AE) cases such as patient demographics, medical history, and clinical data.
• Case Follow-Up: Managing follow-up for adverse event cases, including additional information and outcomes.
• Data Validation: Ensuring data accuracy and completeness during case entry and follow-up.
• Case Prioritization: Setting priority levels for different cases based on severity or regulatory importance.

4. Adverse Event Reporting

• ICSR (Individual Case Safety Report): Understanding how to create and submit Individual Case Safety Reports for regulatory compliance.
• Handling Serious Adverse Events (SAE): Special handling of serious cases, including required follow-up and documentation.
• Safety Data Entry: Inputting data on drugs, medical conditions, laboratory results, and outcomes.
• Managing MedDRA and WHO Drug Dictionaries: Understanding and working with these standard coding systems for adverse events and drugs.

5. Regulatory Compliance and Submissions

• Regulatory Requirements: Overview of global regulatory frameworks for adverse event reporting (e.g., FDA, EMA, ICH).
• Preparing Reports for Regulatory Authorities: Creating reports for submission to regulatory bodies, including ICSR and other required documentation.
• E2B (Electronic Reporting Format): Working with the E2B format for electronic submissions and ensuring regulatory compliance.
• Periodic Safety Update Reports (PSUR): Generating reports for ongoing safety evaluation during a drug’s lifecycle.

6. Signal Detection and Risk Management

• Signal Detection Tools: Using Argus’ signal detection features to identify trends and safety signals in adverse event data.
• Risk Assessment: Tools for assessing the risks associated with drugs based on AE data.
• Risk Management Plans: Developing and managing risk management strategies for ongoing safety surveillance.
• Trending and Analysis: Analyzing data to spot patterns and potential risks in drug safety.

7. Reporting and Analytics

• Standard Reports: Generating common reports such as AE case reports, safety summaries, and regulatory submission reports.
• Custom Reports: How to design custom reports based on specific queries and data fields.
• Data Analytics Tools: Introduction to Argus’ analytical tools for data review and safety monitoring, including graphical views of adverse events, frequency tables, and timelines.
• Key Performance Indicators (KPIs): Setting up and tracking KPIs for pharmacovigilance processes.

8. System Configuration and Administration

• Administering Argus: Role-based access control, user management, and defining permissions.
• System Configuration: Configuring safety case workflows, managing coding dictionaries (e.g., MedDRA), and customizing safety reporting templates.
• System Maintenance: Overview of software updates, backups, and data integrity checks.
• Audit Trails: Managing and reviewing audit trails for compliance tracking.

9. Integration with Other Systems

• Argus Integration: Integrating Argus with other pharmaceutical systems like Clinical Trial Management Systems (CTMS), Electronic Health Records (EHR), and other pharmacovigilance tools.
• Data Exchange: Ensuring seamless data exchange between Argus and other systems using standards like HL7 and EDI.
• Cloud-based Integration: Exploring cloud-based solutions and how Argus can be integrated with cloud systems.

10. Advanced Features and Use Cases

• Advanced Case Search and Filtering: Using complex queries to search for specific adverse event data.
• Managing Complex Cases: Handling cases that involve multiple drugs, complex medical histories, and follow-up.
• Safety Reporting in Multiple Languages: Managing multilingual case handling for global submissions.
• Risk Minimization and Mitigation Strategies: Creating and tracking risk minimization plans (e.g., REMS in the U.S.) in Argus.