Contents

List of Figures

List of Tables

Title and Copyright Information

Preface

• Audience
• Documentation Accessibility
• Related Documents
• Conventions

Part I Understanding the Delivered Integration

1 Understanding the Adverse Event: InForm and Argus Safety Integration

• 1.1 Overview
• 1.2 Key Benefits of the Integration
• 1.3 Participating Applications Overview
  • 1.3.1 Oracle Argus Safety
  • 1.3.2 Oracle Health Sciences InForm
  • 1.3.3 Oracle Health Sciences InForm Adapter (Optional)
  • 1.3.4 Oracle Health Sciences InForm Publisher
• 1.4 Business Process Flow
  • 1.4.1 Logical Data Model Diagram
• 1.5 Solution Assumptions and Constraints

2 Understanding the Sending of Safety Event Information from InForm to Oracle Argus Safety

• 2.1 Overview
• 2.2 Functional Process Flow
  • 2.2.1 Sending Initial Safety Event data from Oracle Health Sciences InForm to Oracle Argus Safety
    • 2.2.1.1 Marking Form to be Sent to Safety
    • 2.2.1.2 Sending the Safety Event
  • 2.2.2 Sending Follow-up Data from Oracle Health Sciences InForm to Oracle Argus Safety
  • 2.2.3 Sending Nullification of a Case from Oracle Health Sciences InForm to Oracle Argus Safety
  • 2.2.4 Viewing the Oracle Health Sciences InForm Safety Event from Within Oracle Argus Safety
  • 2.2.5 Overview of the Integration Solution
• 2.3 Participating Oracle Argus Safety Interfaces
• 2.4 Participating Oracle Health Sciences InForm Interfaces
  • 2.4.1 Oracle Health Sciences InForm Adapter
  • 2.4.2 Oracle Health Sciences InForm Publisher
• 2.5 Industry AIA Components
• 2.6 Integration Services

Part II Implementing the Delivered Integration

3 Implementing the Adverse Event: InForm and Argus Safety Integration

• 3.1 Prerequisites for Implementing the Integration for a Trial
• 3.2 Data Requirements
• 3.3 Study Design for Oracle Health Sciences InForm and Oracle Argus Safety Integration
  • 3.3.1 Overview of Designing for Integration
  • 3.3.2 Designing Items on Forms
    • 3.3.2.1 Items that Trigger Rules
    • 3.3.2.2 Items for Information Returned from the Oracle Argus Safety Application
    • 3.3.2.3 Items Not Entered in the InForm User Interface
    • 3.3.2.4 Hidden Items
    • 3.3.2.5 Fixed Items in a Repeating Data Itemset
    • 3.3.2.6 AE Start Date Item
    • 3.3.2.7 Death Date and Patient Autopsy Completed Code Items
    • 3.3.2.8 Sequence Number Item
  • 3.3.3 Designing Rules
    • 3.3.3.1 _SavetoDB Function
    • 3.3.3.2 Importing the _SavetoDB Function
    • 3.3.3.3 Sample Rule Scenarios
    • 3.3.3.4 Optional Rules
  • 3.3.4 Designing Logical Schemas/Data Mappings
    • 3.3.4.1 About the SafetyLogicalSchema Logical Schema/Data Mapping
    • 3.3.4.2 Mappings for Flat Data Sets
    • 3.3.4.3 Mappings for Repeating Data Sets
    • 3.3.4.4 Mappings for Items that Occur in More than One Form or Visit
    • 3.3.4.5 Mappings for Coded Items
    • 3.3.4.6 Mapping Items Coded in the Oracle Health Sciences InForm Application
    • 3.3.4.7 Mapping Items to Be Coded in the Oracle Argus Safety Application
    • 3.3.4.8 Mapping the MedDRA Version for Coded Items
    • 3.3.4.9 Mappings for Items with Units
    • 3.3.4.10 Mapping an Item That Includes Units
    • 3.3.4.11 Mapping an Item with a Separate Units Item
    • 3.3.4.12 Mappings for Multiple AE Forms
    • 3.3.4.13 Mappings for Custom Data Series
  • 3.3.5 Sample Studies and Logical Schema/Data Mapping
    • 3.3.5.1 Installing the Sample Studies and Logical Schema/Data Mapping Library
  • 3.3.6 Data Set Definitions-System Data Sets
    • 3.3.6.1 Safety_Config Data Set
    • 3.3.6.2 Safety_Significant Data Set
  • 3.3.7 Data Set and Data Series Definitions-Message Body Data Sets
    • 3.3.7.1 Safety_Case Data Set
    • 3.3.7.2 Subject Data Set
    • 3.3.7.3 Subject_AdverseEvent Data Set
    • 3.3.7.4 Subject_Autopsy Data Set
    • 3.3.7.5 Subject_CauseOfDeath Data Set
    • 3.3.7.6 Subject_ConMed Data Set
    • 3.3.7.7 Mapping Dosage Frequency Items in the Subject_ConMed Data Set
    • 3.3.7.8 Subject_Death Data Set
    • 3.3.7.9 Subject_LabTest Data Set
    • 3.3.7.10 Subject_MedicalHistory Data Set
    • 3.3.7.11 Subject_PastDrugHistory Data Set
    • 3.3.7.12 Subject_SuspectDrug Data Set
    • 3.3.7.13 Mapping Dosage Frequency Items in the Subject_SuspectDrug Data Set
    • 3.3.7.14 Subject_SuspectDrug_ReactionRecurrence Data Set
    • 3.3.7.15 Subject_SuspectDrug_ReactionRelatedness Data Set
    • 3.3.7.16 MedicalDevice Data Set
    • 3.3.7.17 MedicalDevice_Evaluation Data Set
    • 3.3.7.18 MedicalDevice_EventProblem Data Set
    • 3.3.7.19 MedicalDevice_RemedialAction Data Set
    • 3.3.7.20 MedicalDevice_Reprocessor Data Set
    • 3.3.7.21 Reporter Data Set
• 3.4 Setting up Participating Applications
  • 3.4.1 Setting up Oracle Health Sciences InForm
    • 3.4.1.1 Configuring Oracle Health Sciences InForm Publisher
    • 3.4.1.2 Registering the Trial with Oracle Health Sciences InForm Adapter
  • 3.4.2 Setting up Oracle Argus Safety
• 3.5 Configuration Properties for the Adverse Event: InForm and Argus Safety Integration
• 3.6 Updating Server Information for Oracle Health Sciences InForm and Oracle Argus Safety
  • 3.6.1 Modifying Information About InForm Trial
  • 3.6.2 Modifying Information About InForm
    • 3.6.2.1 Modifying the InForm Adapter Authentication Credential
  • 3.6.3 Configuring a Different Oracle Argus Safety Interchange Server
  • 3.6.4 Configuring a Different Folder for Oracle Argus Safety Interchange Server
• 3.7 Identifying Cross-references
• 3.8 Working with Domain Value Maps
• 3.9 Using the Message Resubmission Utility
• 3.10 Updating DVMs Used for Configurations
  • 3.10.1 HS_TRIAL_SAFETY_CONFIG DVM
  • 3.10.2 HS_PRODUCT_SAFETY_CONFIG DVM
• 3.11 Extending the Integration
  • 3.11.1 Sending Additional Data from Oracle Health Sciences InForm to Oracle Argus Safety
    • 3.11.1.1 SOA Server Customization
  • 3.11.2 Enabling Customization for Argus Safety Non User-Defined Fields
    • 3.11.2.1 InForm Customization
    • 3.11.2.2 SOA Server Customization
    • 3.11.2.3 Argus Customization
  • 3.11.3 Enabling Calling Out To Your Own Web Services
• 3.12 Finding Oracle Enterprise Manager Instances Using Composite Sensors
• 3.13 Error Handling