Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

• Intended Audience
• Documentation Accessibility
• Related Documents
• About This Book
• Changes to the DCAPI for This Release
• Conventions

Checking My Oracle Support (MetaLink)

• Creating an Account
• Navigating to the Oracle Clinical 4.6 Knowledge Page
• Finding the Latest Oracle Clinical 4.6 Patches
• Finding a Patch or Document When You Know Its Number
• Oracle CPU Security Updates

1 Customer-Defined Identifier Handling

• Overview
  • ValidateName
  • ValidateDocument
  • DeriveDocumentNumber
  • DefaultBookPageNumber
  • TrimPageNumber
  • ChangePageStatus
  • AddPhysPageNumber

2 Interface Configuration

• Overview
  • Study Planning
  • Drug Supply
  • Investigator Management
  • Thesaurus
• Interface Procedures to Be Maintained by the Customer
  • Prevent Study Deletion
  • Delete Interface Records
  • Delete Local Records
  • Prevent Region Deletion
  • Update Region Code
  • Treatment Pattern Deletion Check
  • Treatment Assignment Deletion Check
  • Get the Value of a Study Site Code
  • Validate a Study Site Code
  • Check That a Study Site Code Can Be Changed
• Detailed Table Layouts
  • Drug Supply System
    • OCL_DOSAGE_FORMS
    • OCL_PRODUCT_MASTERS
  • Investigator Management System
    • OCL_INVESTIGATORS
    • OCL_SITES
    • OCL_STUDY_SITES
    • OCL_STUDY_SITE_ROLES
  • Study Planning
    • OCL_ORGANIZATION_UNITS
    • OCL_PROGRAMS
    • OCL_PROJECTS
    • OCL_PROGRAM_PRODUCT_MASTERS
    • OCL_STUDIES
    • OCL_STUDY_REGIONS

3 Integration with External Systems

• Usage Overview
  • Entering Data for the Workflow Option
  • Working from the Discrepancy Management System
  • Working with DCFs
• Customizing Oracle Clinical
  • Enabling External Systems
  • Menu Customization
    • CustomPgmUnit1
    • CustomPgmUnit2
    • CustomPgmUnit3
    • CustomPgmUnit4
    • CustomPgmUnit5
  • Some Possible Ways to Work with the API
  • Workflow API Functions
    • get_next_CRF_work_item
    • get_next_document
    • get_next_image
    • get_previous_image
    • get_next_dcf_image
    • get_previous_dcf_image
    • mark_workflow
    • close_workflow
    • getimage
    • getImageDCF
    • wnfi
    • webpasskeys
    • is_web2

4 Data Capture API Overview

• Using the API
  • File Locations
  • Setting Up Linkage in Microsoft Visual C++
    • Header File
    • Library File
  • Sample C Programs
    • Downloading the Sample Programs Document from MetaLink
  • Auditing Considerations
  • Auditing and Backward Compatibility
    • Key or Comments Changes to RDCIs/RDCMs, and Soft-deletions of Documents
    • Investigator Comment Changes
    • Deletion of Repeats
• About the Data Capture API Documentation
• Special Notes About the API
  • Accessible Documents
  • Date Formats
  • Error Handling
  • Indicating NULL for Number Fields
  • Overall Memory Allocation and Management
  • Memory Allocation Rules for Data Entry
• Procedure Classification
  • Using Execution Context
    • ON-LINE/DCM
    • ON-LINE
    • OFF-LINE
    • SINGLE
  • Relationship Between Procedure Definition and Procedure Execution
• Security Access for the API
• Database Roles for the API
• Calling API Functions
  • Functional State Mapping Information
  • Functional State Transition Diagram
• Data Management Rules

5 DCAPI Structure Type Definitions

• ActualEventsRecord
• AuditInfo
• DataComment
• DiscInfo
• ErrorInfo
• ExternalContextInfo
• GroupId
• MvInfo
• PatientRecord
• QuestionId
• RdciKeysRecord
• RdciRecord
• RdcmArr
• RdcmKeysRecord
• RdcmRecord
• ResponseData
• RepeatId
• ResponseId
• StudyRecord
• ValueText

6 Data Capture API Functions

• Functions Grouped by Task
• ConnectOCL
• CreateRdci
• DeleteRdci
• DeleteRepeat
• DisconnectOCL
• EnrollPatient
• ExecuteMultivariate
• FetchRdci
• FlushRdciRdcm
• FlushResponses
• GetError
• GetErrorStackSize
• GetManualDiscrepancy
• GetNumRows
• GetQuestGroupId
• GetQuestionId
• GetRdci
• GetRdcm
• GetRdcmArr
• GetResponse
• GetUnivDiscrepancy
• InitializeRdcmResponses
• InsertRepeat
• ProcessRdci
• ProcessRdcm
• SetActualEvent
• SetDataComment
• SetExternalContext
• SetManualDiscrepancy
• SetMiscDiscrepancy
• SetPageStatus
• SetRdci
• SetRdcm
• SetResponseData
• SetStudyContext
• SetUnivDiscrepancy
• WriteRdciRdcm
• WriteResponses

A Error Messages

Index