Pharmacovigilance Argus Safety Course Content

Pharmacovigilance-Argus safety database:

• Clinical Development process
• Different phases of Clinical Trials
• CRO and Clinical Research Team
• Case Report Forms
• Data Coding
• IB, Protocol and Informed consent form
• History and overview of Pharmacovigilance Regulatory Authorities
• Pharmacovigilance in India
• Spontaneous reporting
• Active pharmacovigilance
• Adverse Events and its types
• Drug Safety in clinical trials and post marketed drugs Different sources of Adverse Events reporting Different types of AE Reporting Forms
• Expedited reporting and its timelines
• Aggregate reporting
• Different departments working on Pharmacovigilance Four factors for the reportable case
• Causality assessment of the adverse event
• MedDRA and WHODD coding
• SAE narrative writing
• PSUR and its submission timelines
• Practical Hands-on Training on Oracle Argus Safety Database Argus Console PV Overview
• PV Business process
• Introduction to Oracle Argus Safety Database
• Family, Product and License creation Clinical Study configuration
• Sites, users and Groups creation Workflow Configuration
• Case priority Configuration Case Numbering
• Field Validation
• Code list Configuration

Argus Safety

• Different icons used during the case processing and their purpose.
• Different tabs used in case processing
• Case Bookin and Data entry
• Case Processing
• Case Routing Based on workflow
• Case Quality check, Medical review
• Duplicate case check or verification
• Report Generation for Regulatory Submission
• Expedited Reports and Aggregate Reports
• Case Bookin in LAM and Routing to Central Safety database
• MedDRA coding and WHO DD coding Narrative Writing