Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

• Audience
• Documentation Accessibility
• Finding Information and Patches on My Oracle Support
• Finding Oracle Documentation
• Related Documents
• Conventions

1 Overview

• About the Oracle Life Sciences Data Hub
• Developing Programs and Applications
• Loading Data
• Storing Data
• Operating on Data
• Reporting Data
• Automating Multiple Processes
• Viewing Data
• Transferring Data Out of the Oracle Life Sciences Data Hub
• Validating Object Definitions and Instances
• Reusing Object Definitions
• Migrating Existing Programs, Data Sets, and Tables from Other Systems

2 Designing and Using the Oracle Life Sciences Data Hub

• Designing Your Implementation of the Oracle Life Sciences Data Hub
  • Organizational Structure
  • Security System
  • Classification System
  • Subtypes
  • Object Validation Standards
• Setting Up and Using the Oracle Life Sciences Data Hub
  • Phase 1: Implementation Design
  • Phase 2: Implementation Setup and Maintenance
  • Phase 3: Application and Data Repository Development and Maintenance
  • Phase 4: Information Retrieval

3 Designing an Organizational Structure

• What is the Organizational Structure?
• Domains
• Application Areas
• Work Areas
  • Data Flow
  • Installing Work Areas
  • Cloning Work Areas
  • Using Work Areas
• Examples of Organization Design
  • Example 1: Project Domain with Reporting on Separately Stored Study Data
  • Example 2: Project Domain with Reporting on Pooled Data
  • Example 3: Domain for Companywide Reports
  • Example 4: Domain for Standard Definitions
  • Example 5: Oracle Clinical Definitions
  • Example 6: Domain for Cross-Project Analysis
  • Example 7: Study or Project Template Domain
• Design Considerations
• Design Decision Summary
  • Domains
  • Application Areas
  • Work Areas

4 Designing a Security System

• About Security Design in the Oracle Life Sciences Data Hub
• Object Security Elements
  • Object Subtypes
    • Subtypes and Security
    • Subtypes and Classification
    • Subtype Inheritance
  • Roles
    • Roles Based on Job Description
    • Oracle LSH-Specific Roles
    • Application Roles
  • User Groups
    • Explicit User Group Assignment to Objects
    • User Group Assignment by Inheritance
    • Duplicate Assignments
  • Users
• User Interface Security
  • Application Roles
  • Administrator Roles
• Security for Blinded Data
  • About Data Blinding, Blind Breaks, and Unblinding
  • Blinding-Related Security Privileges
    • Blinding-Related Object Security Operations
    • Blinding-Related Application Roles
  • Interaction of Blinding Statuses and User Privileges on Executing Jobs and Viewing Data
• Example of Security Design
  • Example User Groups
    • Project 123 Domain User Group
    • Study 123ABC Development User Group
    • Study 123ABC Quality Control User Group
    • Study 123ABC Production User Group
    • User Groups for the Other Domains, Application Areas, and Work Areas
  • Example Users
• Design Decision Summary
  • Design an Organizational Structure
  • Design a Set of User Groups
  • (Optional) Design One or More Object Subtypes
  • Design a Set of Roles and their User Group Assignments

5 Designing a Classification System for Searching and Browsing

• About Classification
• Designing a Classification System
• Defining Classification Hierarchies
  • Multilevel Hierarchies
  • Single-Level "Hierarchies"
  • Defining Hierarchy Levels
  • Defining Classification Values
• Assigning Classification Levels to Object Subtypes
  • About Subtypes and Classification
  • Making a Classification Level Mandatory
  • Allowing Classification by Inheritance
  • Setting a Default Classification
• Classifying Outputs
• Classification Example
  • Classification Hierarchies for Use in Browsing and Searching
    • Project > Study > Site > Patient
    • Division > Department > Group
  • Classification Hierarchies for Use in Searching Only
• Design Decision Summary
  • Design a Set of Classification Hierarchies with Levels and Values
  • Assign Hierarchy Levels to Object Subtypes
  • Assign Hierarchy Levels to Domains, Application Areas, and Work Areas

6 Validating Objects and Outputs

• About Validation
• Validation Statuses
  • Development
  • Quality Control
  • Production
  • Retired
• Validation-Related Security
• Validation Supporting Information
  • Supporting Documents
  • Supporting Outputs
• Output Coversheets
• Cascading Validation
• Work Area Usage Intent and Validation Status
• Validation Rules
• Design Decision Summary
  • Supporting Information
  • Security

A Object Types with Operations

• Organizational Object Types
  • Organizational Objects Used in Definition
  • Organizational Objects Used in Administration
• Primary Object Types
• Secondary Object Types
  • Secondary Objects Contained in Organizational Objects
  • Secondary Objects Contained in Instance Objects
  • Secondary Object Types Contained in Administrative Organizational Objects
• Instance Object Types
• Outputs

B Object Ownership

• Domains
• Application Areas
• Work Areas

Glossary