Preface

This document describes the steps for installing and configuring the components of the Argus Safety Unblinding application.

Audience

This document is technical in nature and presents technical details about the processes it discusses. It assumes that you are a qualified ORACLE Database Administrator. We recommend reading the entire document before execution the Interface programs.

About This Book

This manual contains five chapters:

Chapter 1, "Setting up EOSU Database"

This section provides information for setting up the EOSU database including:

• Creating a Spool/Log Directory

• Setting Up the Argus_EOSU Schema

• Creating an End of Unblinding Study Argus Group

• Suggestions for Improving Performance

Chapter 2, "Using the EOSU Generic Software"

Provides information for configuring and using the EOSU software including:

• Logging in to EOSU and Starting a Profile Configuration

• Configuring a New EOSU Profile

• Copying, Modifying, and Deleting Profiles

• Executing an EOSU Profile

• Using the EOSU Report Viewer

• Exiting from EOSU

Chapter 3, "Dropping/Uninstalling EOSU"

Provide instructions for uninstalling EOSU.

Chapter 4, "Argus Pre- and Post-Upgrade tasks"

This section outlines the tasks you should perform before and after the upgrade.

Chapter 5, "Database Maintenance"

This section provides information about database backup and restore tasks.

Documentation Accessibility

Our goal is to make Oracle products, services, and supporting documentation accessible to all users, including users that are disabled. To that end, our documentation includes features that make information available to users of assistive technology. This documentation is available in HTML format, and contains markup to facilitate access by the disabled community. Accessibility standards will continue to evolve over time, and Oracle is actively engaged with other market-leading technology vendors to address technical obstacles so that our documentation can be accessible to all of our customers. For more information, visit the Oracle Accessibility Program Web site at http://www.oracle.com/accessibility/.

Accessibility of Code Examples in Documentation

Screen readers may not always correctly read the code examples in this document. The conventions for writing code require that closing braces should appear on an otherwise empty line; however, some screen readers may not always read a line of text that consists solely of a bracket or brace.

Accessibility of Links to External Web Sites in Documentation

This documentation may contain links to Web sites of other companies or organizations that Oracle does not own or control. Oracle neither evaluates nor makes any representations regarding the accessibility of these Web sites.

Access to Oracle Support

Oracle customers have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/support/contact.html or visit http://www.oracle.com/accessibility/support.html if you are hearing impaired.

Related Documents

This section lists the manuals for all Oracle Life Sciences products. You can order printed manuals from the Oracle iStore. From the iStore, search for the part number in parentheses.

Oracle Argus Documentation The documentation set includes:

• Oracle Argus Installation Guide (E15951)

• Oracle Argus Interchange User's Guide (E15946)

• Oracle Argus Affiliate User's Guide (E15947)

• Oracle Argus Safety Console User's Guide (E15950)

• Oracle Argus Safety User's Guide (E15952-01)

• Oracle Argus Safety End of Study Unblinding User's Guide (E15956)

• Oracle Argus Dossier User's Guide (E15945)

Oracle Clinical Documentation

The Oracle Clinical documentation set includes:

• Oracle Clinical Installation Guide E15951)

• Oracle Argus Interchange User's Guide (E15946)

• Oracle Argus Affiliate User's Guide (E15947)

• Oracle Argus Safety Console User's Guide (E15950)

• Oracle Argus Safety User's Guide (E15952-01)

Oracle Clinical Documentation

The Oracle Clinical documentation set includes:

• Oracle Clinical Installation Guide E15951)

• Oracle Argus Interchange User's Guide (E15946)

• Oracle Argus Affiliate User's Guide (E15947)

• Oracle Argus Safety Console User's Guide (E15950)

• Oracle Argus Safety User's Guide (E15952-01)

• Oracle Argus Safety End of Study Dossier User's Guide (E15945)

Oracle Clinical Documentation

The Oracle Clinical documentation set (A83790) includes:

• Oracle Clinical Administrator's Guide (A83791)

• Oracle Clinical Getting Started (B12308)

• Interfacing from Oracle Clinical (A83793)

• Oracle Clinical Conducting a Study (A85201)

• Oracle Clinical Creating a Study (A85200)

• Oracle Clinical Installation Guide (A83779)

Oracle Clinical NLS Option Documentation

The Oracle Clinical NLS Option documentation includes:

• Oracle Clinical NLS Option User Guide (A90473)

Oracle Thesaurus Management System (TMS) Documentation

The TMS documentation includes:

• Oracle Thesaurus Management System User Guide (A82842)

• Oracle Thesaurus Management System Installation Guide (A83780)

Oracle Adverse Event Reporting System (AERS) Documentation

The Oracle AERS documentation set (B10328) includes:

• Oracle Adverse Event Reporting System Administrator's Guide (B10330)

• Oracle Adverse Event Reporting System Installation Guide (B10331)

• Oracle Adverse Event Reporting System User's Guide (B10329)

• Oracle Adverse Event Reporting System Quick Guide (B14419)

Oracle Clinical Remote Data Capture (RDC) Documentation

The Oracle RDC documentation includes:

• Oracle Clinical Remote Data Capture Classic Data Entry User's Guide (B13921)

• Oracle Clinical Remote Data Capture PDF Data Entry User's Guide (B139201)

Oracle Clinical SiteMinder Documentation

The Oracle Clinical SiteMinder documentation includes:

• Oracle Clinical SiteMinder User Guide (B15643)

• Oracle Clinical SiteMinder Installation Guide (B15645)

Oracle Clinical TrialMinder Documentation

The Oracle Clinical TrialMinder documentation includes:

• Oracle Clinical TrialMinder User Guide (B15644)

• Oracle Clinical TrialMinder Installation Guide (B15646)

In addition, Oracle Health Science Global Business Usit (HSGBU) publishes PDF-format Technical Reference Manuals (TRMs) containing proprietary information on internal tables and APIs. If you are a licensed customer, contact Oracle Support to obtain a free electronic copy. This is a list of the available TRMs:

• Oracle Clinical Stable Interface TRM (A83796)

• Oracle Thesaurus Management System TRM (A82841)

• Oracle Adverse Event Reporting System Saved Queries TRM (B10353)

• Oracle Adverse Event Reporting System Reports TRM (B10352)

• Oracle Adverse Event Reporting System Edit Checks TRM (B10355)

Conventions

The following text conventions are used in this document:

Convention	Meaning
boldface	Boldface type indicates graphical user interface elements associated with an action, or terms defined in text or the glossary.
italic	Italic type indicates book titles, emphasis, or placeholder variables for which you supply particular values.
monospace	Monospace type indicates commands within a paragraph, URLs, code in examples, text that appears on the screen, or text that you enter.