Oracle Argus Safety Essentials

$299.00

Oracle Argus Safety – software access is optional.

Description

Oracle Argus Safety Essentials is a online eLearning course that covers the basic and advanced concepts of managing drug safety data using the Oracle Argus Safety application. The course starts with an overview of Oracle Argus Safety 8.1.1 and then covers a more detailed look at the various database features, case entry, workflow and reporting. It is intended for students and clinical research professional who are willing to make a career in Pharmacovigilance using the Oracle Argus platform.

The course includes hands-on practical training on Oracle Argus Safety software used as a de-facto standard for managing drug safety data

The program is made up of 1 modules, 8 topics and 9 Quizzes. It first covers the pre-requite topics on Pharmacovigilance and the takes you through the process of navigating the Oracle Argus Safety application. It then covers all the pharmacovigilance tasks performed in Oracle Argus Safety including Case entry, Case Triage, Medical coding, Medical review, Narrative writing, Quality control and Reporting.

On completing your enrolment for the Oracle Argus Safety Essentials program you will instantly get access to our online learning portal.

Looking for a course that includes 24×7 access to Oracle Argus Safety software? Check out this course

Find more information about the Oracle Argus Safety application – What is Oracle Argus Safety

Key Features

 

  • Training on actual Cases used in the industry
  • Course Instructor support via Email
  • Full access to e-Learning Portal containing Recorded Lectures.

Curriculum

Module 0 – Principles of Pharmacovigilance
  • General Overview of Pharmacovigilance
  • History and aim of Pharmacovigilance
  • Drug dependence
  • Vaccine Vigilance
  • Principles of Signal Detection in Pharmacovigilance
  • Communication in Pharmacovigilance
  • Post-Marketing Surveillance
Chapter 1 – Overview and Navigation
  • Process of Logging in
  • User Interface and Navigation
  • Functionality of User Interface Elements
Chapter 2 – Overview of Argus Menus
  • Business Process Workflow
  • Active Cases and Case actions
  • Worklist
  • Reports
  • Dashboard and Utilities
Chapter 3 – Case Form Features
  • Tabs and Fields of Case Form
  • Management of cases using Case Form fields
Chapter 4 – Drug and Event Coding
  • Coding Terms and MedDRA Browser
  • Drug and Event Coding using MedDRA and WHODD
Chapter 5 – Case Entry and Processing
  • Case Management Workflow
  • Case Processing – Spontaneous case
  • Case Processing – Sponsored Trial case
Chapter 6 – Advanced Conditions
  • Overview of Advanced Conditions
  • Building Complex Queries
Chapter 7 – Reporting and Submissions
  • Reporting Capabilities of Argus Safety
  • Periodic Safety Update Reports (PSUR)
  • Clinical Trial Periodic Reports (CTPR)
  • IND and NDA Reports
  • Case Data Analysis, Case Listing, CIOMS II Line Listing
Course Completion
  • Final Assessment
  • Course Certification

Certification

 

At the end of the course, students will be awarded a certificate of completion.

Duration

 

The duration of this program is 2 months.

You will have access to the course for the duration of the program.

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