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Oracle® Health Sciences Adverse Event Integration Pack for Oracle Health Sciences InForm and Oracle Argus Safety Implementation Guide
Release 1.0.1
E36157-02
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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