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Oracle® Life Sciences Data Hub Implementation Guide
Release 2.2.2
E57453-01
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Contents
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