1/17

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 Clinical Documentation
• Conventions

Part I Customizing Oracle Clinical

1 Custom Workflows, Menus, and Image Handling

• Usage Overview
  • Entering Data for the Workflow Option
  • Working from the Discrepancy Management System
  • Working with DCFs
• 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

2 Custom Identifier Handling

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

Part II Interfacing with the Design Subsystem

3 Interface Tables and Views

• 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
• Table Details
  • 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

4 Web Services

• Setting Up Web Services
  • Prerequisites
  • Installing the Oracle Clinical Web Services
    • Installing the Oracle Web Service Manager (OWSM)
    • Installing the Oracle Clinical Web Services in the WebLogic Server
  • Configuring Certificates
    • Server Side Configuration
    • Client Side Configuration
• Available Web Services
  • Investigator Service
    • Create Investigator
    • Update Investigator
    • Request Investigator
    • Delete Investigator
  • Site Service
    • Create Site
    • Update Site
    • Request Site
    • Delete Site
  • Study Site Service
    • Create Study Site
    • Update Study Site
    • Assign Investigator
    • Request Current Investigator Assignment
    • Request Investigator Assignment
    • Delete Investigator Assignment
    • Request Study Site
    • Delete Study Site
  • Partial Source Data Verification Web Service
    • Testing the PSDV Web Service

Part III Interfacing with the Data Entry Subsystem

5 Data Capture API Overview

• Using the API
  • File Locations
  • Setting Up Linkage in Microsoft Visual C++
    • Header File
    • Static Library File
  • Sample C Programs
  • 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

6 DCAPI Structure Type Definitions

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

7 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