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Oracle® Study, Subject, and Visit Synchronization Integration Pack for Siebel Clinical and Oracle Clinical Implementation Guide
Release 11.1

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2 Synchronizing Clinical Study Sites

This chapter provides an overview of the synchronization of Clinical Study Sites between Siebel Clinical and Oracle Clinical and discusses:

2.1 Overview

Study site information is entered as a Protocol Site in Siebel Clinical and a Study Site in Oracle Clinical. This integration is unidirectional and happens from Siebel Clinical to Oracle Clinical. Updates to the investigator, site, or study site in Siebel Clinical are synchronized to Oracle Clinical. Updates made in Oracle Clinical for investigator, site, or study site are not synchronized back to Siebel Clinical.

When the Activate for the Synchronization flag is selected for a protocol site in Siebel Clinical, a corresponding study site will be created in Oracle Clinical. If the principal investigator responsible for the protocol site does not exist in Oracle Clinical, one will be created. The combination of the account and the primary address for the Protocol Site is considered as a Site in Oracle Clinical. If this combination does not exist, a new site is created.

Deleting a principal investigator, account, or protocol site in Siebel Clinical will not cause deletion of any objects in Oracle Clinical.

2.2 Study Site Integration Flow

This section provides the activity diagrams and functional descriptions for the Study Site Integration flow.

Flow Diagram

The following diagram shows the Study Site Integration flow:

Figure 2-1 Study Site Integration Flow

Description of Figure 2-1 follows
Description of "Figure 2-1 Study Site Integration Flow"

2.2.1 Create Study Site Flow

The following points describe the Create Study Site flow:

  1. When the Activate for Synchronization check box is selected for a Protocol Site, Siebel Clinical writes a message Application Business Message (ABM) to the AIA_SiebelClinical_ClinicalStudyJMSQueue Queue.

  2. The UpdateClinicalStudySEBLJMSConsumer consumer picks the ABM and passes it to the UpdateClinicalStudySEBLHealthSciencesReqABCSImpl (requester Application Business Connector Service (ABCS)).

  3. The requester ABCS transforms the ABM into an UpdateClinicalStudyEBM, populating the ClinicalStudyInvestigator, ClinicalStudySite and ClinicalStudyStudySite cross-reference tables. It retrieves State and Country information for the Site Address from the corresponding DVM tables.

  4. The Enterprise Business Message (EBM) is then passed onto the HealthSciencesClinicalStudyEBS (EBS).

  5. The EBS will pass the EBM to the UpdateClinicalStudyOCHealthSciencesProvABCSImpl (provider ABCS) based on the configuration routing rules.

  6. The provider ABCS receives the EBM and transforms it into either a Create Investigator ABM (if the Investigator is new) or an Update Investigator ABM (if the Investigator already exists). The ABM is then passed to the appropriate Oracle Clinical Web service.

  7. If the investigator value in the CreateInvestigator ABM is longer than 10 characters, it is replaced with the sequence number used for the investigator_id field in the ocl_investigators table.

  8. If a new Investigator has been created, the ClinicalStudyInvestigator cross-reference table is updated.

  9. The provider ABCS then transforms the EBM into either a Create Site ABM (if the Site is new) or an Update Site ABM (if the Site already exists). The Oracle Clinical state and country values are retrieved from the corresponding DVM tables.

  10. The ABM is then passed to the appropriate Oracle Clinical Web service.

  11. If the site value in the Create Site ABM is longer than 10 characters, it is replaced with the sequence number used for the site_id field in the ocl_sites table.

  12. If a new Site has been created, the ClinicalStudySite cross-reference table is updated.

  13. The provider ABCS then transforms the EBM into a Create StudySite ABM, which includes Oracle Clinical identifiers for the Site and Investigator (from the corresponding cross-reference tables).

  14. A synchronous call to the Oracle Clinical Web service is made and the ID of the newly created StudySite is returned. This can then be added to the ClinicalStudyStudySite cross-reference table.

2.2.2 Update Study Site Flow

The following points describe the Update Study Site flow:

  1. When the Activate for Synchronization check box is selected for a Protocol Site and its information is updated (for example address of Protocol Site), Siebel Clinical writes a message (ABM) to the AIA_SiebelClinical_ClinicalStudyJMSQueue queue.

  2. The UpdateClinicalStudySEBLJMSConsumer consumer service picks the message and passes it to the UpdateClinicalStudySEBLHealthSciencesReqABCSImpl (requester ABCS).

  3. The requester ABCS transforms the ABM into an UpdateClinicalStudy EBM. This EBM contains integration IDs for the Investigator, Site, and StudySite, which are retrieved from the corresponding cross-reference tables. The state and country values in the site address are retrieved from the corresponding DVMs.

  4. The EBM is then passed onto the HealthSciencesClinicalStudyEBS (EBS).

  5. The EBS passes the EBM to the UpdateClinicalStudyOCHealthSciencesProvABCSImpl (provider ABCS), based on the configuration routing rules.

  6. The provider ABCS receives the EBM and transforms it into either a Create Investigator ABM (if the Investigator is new) or an Update Investigator ABM (if the Investigator already exists). The ABM is then passed to the appropriate Oracle Clinical Web service.

  7. If the investigator value in the CreateInvestigator ABM is longer than 10 characters, it is replaced with the sequence number used for the investigator_id field in the ocl_investigators table.

  8. If a new Investigator has been created, the ClinicalStudyInvestigator cross-reference table is updated.

  9. The provider ABCS then transforms the EBM into either a Create Site ABM (if the Site is new) or an Update Site ABM (if the Site already exists). The Oracle Clinical values for the site address state and country are retrieved from the corresponding DVM tables.

  10. The ABM is then passed to the appropriate Oracle Clinical Web service.

  11. If the site value in the CreateSite ABM is longer than 10 characters, it is replaced with the sequence number used for the site_id field in the ocl_sites table.

  12. If a new Site has been created the ClinicalStudySite cross-reference table is updated.

  13. The provider ABCS then transforms the EBM into an Update Study Site ABM, which includes Oracle Clinical identifiers for the Site and Investigator (from the corresponding cross-reference tables).

  14. A synchronous call to the Oracle Clinical Web service is made.

2.3 Siebel Clinical Interfaces

The following table describes the Siebel Outbound Web services:

Table 2-1 Siebel Outbound Web Services

Name Schema

ClinicalProtocolSite

Clinical Protocol Site Business Object


2.4 Oracle Clinical Interfaces

The integration uses the following Oracle Clinical artifacts:

Inbound to Oracle Clinical Web Services:

2.5 Industry AIA Components

The integration flow uses the following components:

The industry EBO and EBM XML Schema Definition (XSD) files can be located by EBO within the following parent folder:

$AIA_HOME/AIAMetaData/AIAComponents/EnterpriseObjectLibrary/Industry/HealthSciences/EBO/

The industry EBS Web Services Description Language (WSDL) files can be located by EBO within the following parent folder:

$AIA_HOME/AIAMetaData/AIAComponents/EnterpriseBusinessServiceLibrary/Industry/HealthSciences/EBO/

For detailed documentation of individual EBOs and EBMs, click the AIA Reference Doc link on EBO and EBM detail pages in Oracle Enterprise Repository or Oracle Clinical.

For more information about using the Oracle Enterprise Repository and configuring it to provide the AIA Reference Doc link, see Oracle Fusion Middleware Developer's Guide for Oracle Application Integration Architecture Foundation Pack 11g Release 1, "Configuring and Using Oracle Enterprise Repository as the Oracle AIA SOA Repository".

EBOs can be extended, for instance, to add new data elements. These extensions are protected and will remain intact after a patch or an upgrade.

For more information, see Oracle Fusion Middleware Developer's Guide for Oracle Application Integration Architecture Foundation Pack 11g R1, "Extensibility for AIA Artifacts".

2.6 Integration Services

The following are the services delivered with this integration: