Contents

List of Examples

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

What's New

• New in Release 5.0
• New in Release 4.6.2
• New in Release 4.6

1 About the Stable Interface

• Overview
• Synonyms
• Accessing Oracle Clinical Data
  • Table Queries
  • Global Library and Study Objects
  • Self-Journaling Tables
    • Joining Tables
    • About Timestamps
    • Simple User Updates
    • Deleting Records
  • Determining Object Ownership
• Standard Attributes
  • Audit Attributes
  • STATUS_CODE
    • RETIREMENT_REASON_TYPE_CODE
    • STATUS_COMMENT_TEXT
    • LAST_STATUS_CHANGE_TS
  • DOMAIN
  • _FLAG
  • REPLICATION_IND
• Reference Codelists
• Question and Question Group Attribute Hierarchy

2 Table Definitions

• About the Stable Interface Tables
• ACTUAL_EVENTS(T)
• BATCH_DM_RUNS
• CLINICAL_PLANNED_EVENTS
• CLINICAL_STUDIES
• CLINICAL_SUBJECTS
• DATA_CLARIFICATION_FORMS
• DCF_PAGES
• DCI_BOOK_DCI_CONSTRAINTS
• DCIS
• DCI_BOOKS
• DCI_BOOK_PAGES
• DCI_BOOK_PHYSICAL_PAGES
• DCI_FORM_VERSIONS
• DCI_MODULES
• DCI_MODULE_PAGES
• DCMS
• DCM_QUESTIONS
• DCM_QUES_REPEAT_DEFAULTS
• DCM_SCHEDULES
• DISCREPANCY_ENTRIES(T)
• DISCREPANCY_ENTRY_REVIEW_HIST(T)
• DISCRETE_VALUES
• DISCRETE_VALUE_GROUPS
• FORM_LAYOUT_TEMPLATES
• LABS
• LAB_TEST_QUESTION_UNITS
• LAB_RANGE_SUBSETS
• LAB_UNITS
• LAB_UNIT_CONVERSIONS
• MV_EXECUTION_LOG
• OCL_INVESTIGATORS(T)
• OCL_ORGANIZATION_UNITS
• OCL_PROGRAMS
• OCL_PROJECTS
• OCL_SITES
• OCL_STUDIES
• OCL_STUDY_SITES
• OCL_STUDY_SITE_ROLES(T)
• ORACLE_ACCOUNTS
• PATIENT_POSITIONS(T)
• PATIENT_STATUSES
• PLANNED_STUDY_INTERVALS
• PREFERRED_LAB_UNITS
• PROCEDURES
• PROCEDURE_DETAILS
• PROCEDURE_QUESTION_GROUPS
• QUESTIONS
• QUESTION_CATEGORY_RELATIONS
• QUESTION_GROUPS
• QUESTION_GROUP_QUESTIONS
• RANGES
• RDCI_HISTORY(T)
• RECEIVED_DCIS(T)
• RECEIVED_DCMS(T)
• RECEIVED_PAGES(T)
• RECEIVED_PAGE_HISTORY(T)
• REFERENCE_CODELISTS
• REFERENCE_CODELIST_VALUES
• REGIONS
• RESPONSES(T)
• STUDY_SITE_PATIENT_POSITIONS(T)
• TREATMENT_PATTERNS
• VALIDATION_REPORTED_VALUES(T)

3 Flexible Studies Tables

• DCI_BOOK_RULES
• DCI_BOOK_RULE_TGT_INTERVALS
• DCI_BOOK_RULE_TGT_DCIS
• PP_EXPECTED_INTERVALS(T)
• PP_EXPECTED_INTERVALS$JN
• PP_EXPECTED_CPES(T)
• PP_EXPECTED_CPES$JN
• PP_EXPECTED_DCIS(T)
• PP_EXPECTED_DCIS$JN

4 View Definitions

• About the Stable Interface Views
• ACTUAL_EVENTSV(T)
• CHECK_RANDOMIZATIONS
• DISCREPANCY_MANAGEMENT(T)
• FULL_STUDIES
• PATIENTS
• PROGRAM_SUBSTANCES
• TREAT_ASSIGN_ALL_VIEW

5 Entity Relationship Diagram

A Journal and History Tables

• Self-Journaling tables
• Journal Table Columns
• Tables First Audited in Oracle Clinical 4.5
• History Tables
  • CLINICAL_STUDY_HISTORY
  • DCMS_FFL_XML_HIST
  • FORM_LAYOUT_TEMPLATES_XML_HIST
  • PATIENT_POSITIONS_HISTORY
  • RECEIVED_PAGES_HISTORY