Preface

This document describes the steps for using the components of the Oracle Argus Safety Japan application.

Intended Audience

This document is intended for users of the Oracle Argus Safety Japan system.

Documentation Accessibility

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Access to Oracle Support

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About This Book

This guide contains the following chapters:

Chapter 4, "Reports"

Chapter 2, "Case Actions"

Chapter 1, "Case Form"

Chapter 5, "Utilities"

Chapter 3, "Worklist"

The Oracle Health Sciences Safety Suite

This product is part of the Oracle Health Sciences Safety Suite, an integrated solution for end-to-end vigilance from adverse event management to signal management, through the entire lifecycle of a medicinal product from clinical trials to post-marketing surveillance.

The Oracle Health Sciences Safety Suite consists of the following components:

• Oracle Argus Standard Edition: Manage and report adverse events through a workflow including case intake, data entry, coding, quality review, medical review, expedited reporting, and periodic reporting. Modules include Oracle Argus Safety, Oracle Argus Interchange, Oracle Argus Affiliate, Oracle Argus Dossier, Oracle Argus Unblinding, and the Oracle Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus.

• Oracle Argus Enterprise Edition: In addition to managing the adverse event workflow and reporting, employ a powerful and flexible business analytics and intelligence platform for both scientific analysis and operational metrics. Modules include Oracle Argus Analytics, Oracle Argus Insight, Oracle Argus Mart, Oracle Argus Safety, Oracle Argus Interchange, Oracle Argus Affiliate, Oracle Argus Dossier, Oracle Argus Unblinding, and the Oracle Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus.

• Oracle Argus Safety Japan: Manage and report adverse events in Japan, and connect the global and local workflows using a single database.

• Oracle Health Sciences Empirica Topics: Manage and document safety signals through a workflow including validation, prioritization, assessment, confirmation/refutation, and resulting actions.

• Oracle Health Sciences Empirica Study: Detect and analyze safety signals in clinical trial data including adverse events, clinically significant labs, electrocardiograms, vital signs, and shifts from baseline.

• Oracle Health Sciences Empirica Signal: Detect and analyze safety signals in post-marketing spontaneous adverse reaction data including public health authority databases and/or private inhouse databases such as Oracle Argus.

• Oracle Health Sciences Empirica Healthcare Analysis: Evaluate safety signals in healthcare data including electronic medical records and administrative claims, and support pharmacoepidemiology, comparative effectiveness analysis, and health economics and outcomes research.

For more information on Argus Safety, visit the Oracle Health Sciences Safety suite page at:

http://www.oracle.com/goto/pharmacovigilance.html

Conventions

The following text conventions are used in this document:

Convention	Meaning
boldface	Boldface type indicates graphical user interface elements associated with an action such as Buttons, Dialog boxes, Check boxes, Combo boxes, Drop-down lists, Labels, Option (Radio) buttons, Tabs, Text boxes, etc.
"between quotation marks"	Information that may appear as-is on screen, or information provided by the user.
Note	Information that should be noted before proceeding with the instructions.
Important	Important information that must be noted to ensure accurate, reliable, or safe behavior of the system.
Tip	Information that enables easier completion of the current task or helps in completing other tasks.
Bold Underline	Link indicating that additional "pop-down" information is available.
ALL CAPITALS	Keyboard keys
Initial Capitals	Names of user interface elements, modules, applications, proper nouns, etc.