Setting Up and Configuring Clinical Data Capture and Query Management System Integration

This chapter covers setting up and configuring Siebel Clinical Trial Management System for integration with a clinical data capture and query management system, such as Oracle Health Sciences InForm. It includes the following topics:

Overview of Clinical Data Capture and Query Management System Integration

You can use integration Web services for integrating Oracle’s Siebel Clinical Trial Management System with clinical data capture and query management systems. Oracle’s Siebel Clinical Trial Management System is certified for integration with Oracle Health Sciences InForm. For more information about the integration with Oracle Health Sciences InForm, see Oracle Health Sciences InForm Publisher On Demand 2.1 Integration Guide.

You can customize the Web services for integration with any third-party clinical application or for specific business requirements. For more information about customizing Siebel Web services, see Siebel CRM Web Services Reference.

The following integration processes facilitate clinical data capture integration:

Study subject integration. A Siebel Clinical Web service creates screening and enrollment subjects, and enables screening and enrolling against the active subject visit template. Web services create subjects in Siebel Clinical when screening or enrollment data is entered in Oracle Health Sciences InForm.
Activity completion data integration. The integration Web services update the completion dates of visits and activities in the subject visit template. The Siebel Clinical visit and activity completion data is updated using changes to the patient data that is entered in Oracle Health Sciences InForm.

Process of Setting Up Clinical Data Capture and Query Management System Integration

To set up clinical data capture and query management system integration for Siebel Clinical, perform the following tasks:

Activating Workflows for Clinical Data Capture and Query Management System Integration

This task describes how to activate the workflows that are required for clinical data capture and query management system integration. You can use Siebel Business Process Designer to modify the workflows to suit your own business model. For more information, see Siebel Business Process Framework: Workflow Guide.

This task is a step in Process of Setting Up Clinical Data Capture and Query Management System Integration.

To activate workflows for clinical data capture and query management system integration

Navigate to the Administration - Business Process screen, then the Workflow Deployment view.
Query for and activate each of the following workflows:
- SWI LS Clinical Subject Inbound - Subject
- SWI LS Clinical Subject Inbound - Activity
- SWI - Protocol Number Lookup
- LS Clinical - DeleteNonAppVisits Process
Verify that each activated workflow is added to the Active Workflow Processes view at the end of the screen.

Configuring Web Services for Clinical Data Capture and Query Management System Integration

This task describes how to configure the Web services that are required for clinical data capture and query management system integration. For more information about configuring Web services, see Integration Platform Technologies: Siebel Enterprise Application Integration.

Note: It is recommended that you use HTTPS authentication. For information about configuring Secure Sockets Layer (SSL) for HTTPS authentication, see Siebel Security Guide.

This task is a step in Process of Setting Up Clinical Data Capture and Query Management System Integration.

To configure Web services for clinical data capture and query management system integration

Navigate to the Administration - Web Services screen, then the Inbound Web Services view.
Query for each of the following Web services, and update the language and address variables:
- ClinicalSubject Inbound Web service.
- LS Clinical Protocol Site Interface Service
Click Clear Cache on the Inbound Web Services applet.

Configuring Protocol Integration Fields for Oracle Health Sciences InForm Integration

The CDMS Study ID field in Siebel Clinical maps a protocol in Siebel Clinical to a clinical trial in Oracle Health Sciences InForm. Multiple protocols can be associated with a clinical program in Siebel Clinical. When you create a protocol record, you can also add extra information about the protocol, such as financial information, central laboratory information, and so on.

To configure protocol integration fields for Oracle Health Sciences InForm integration

Navigate to the Administration - Clinical screen, then the Protocol List view.
In the Protocol list, query for the correct protocol.
Drill down on the protocol number field.
Navigate to the integration section of the More Info view.

Complete the integration fields.

The integration fields are described in the following table.

Field	Comments
CDMS Study ID	Type the ID of the CDMS study. This required field links a clinical protocol in Siebel Clinical to a clinical study in an external application. For integration with Oracle Health Sciences InForm, set the value to the trial name in Oracle Health Sciences InForm.
Synchronize Active Study Sites	This field is not applicable for InForm integration.
Safety Study ID	This field is not applicable for InForm integration.
Plan Study ID	This field is not applicable for InForm integration.

Integrating Data for Subject Visits with Data for Activities

Subject visit templates allow you to set up a template schedule. The template schedule is based on the protocol document. You use the template schedule to generate screening, rescreening, and enrollment schedules for each subject, according to the subject’s screening, rescreening, and enrollment dates.

The Clinical Item Integration field in the subject visit template is used for integrating visit data with activity data between Siebel Clinical and Oracle Health Sciences InForm.

To integrate data for subject visits data with data for activities

Navigate to the Administration - Clinical screen, then the Visit Templates view.
In the Subject Visit Templates list, create a new record and complete the necessary fields.
The Clinical Item fields in the Visits and Activities applets are automatically populated.

Verify that the Clinical Item fields in the Visits and Activities applets are populated as specified in the following table.

Field	Comments
Visits - Clinical Item	When you create a visit, the clinical item in the Visits applet is populated with the name of the visit. The clinical item value defines the completion criteria for the visit in Oracle Health Sciences InForm. If multiple versions of the subject visit template exist, and some visits are the same in both template versions, then you can specify the same clinical item value. This feature allows both visits to have the same completion criteria in Oracle Health Sciences InForm. Note: The clinical item value for a visit must be unique within a version of a subject visit template.
Activities - Clinical Item	When you create a visit activity, the clinical item in the Activities applet is populated with the value in the Activities Description field. The clinical item value defines the completion criteria for the activity in Oracle Health Sciences InForm. The user often completes the same activity at multiple visits, therefore the user can assign the same clinical item value to each activity, and then define the completion criteria only once in Oracle Health Sciences InForm. Note: The clinical item value for an activity must be unique within a visit in a version of a subject visit template.

Field

Comments

Visits - Clinical Item

When you create a visit, the clinical item in the Visits applet is populated with the name of the visit.

The clinical item value defines the completion criteria for the visit in Oracle Health Sciences InForm. If multiple versions of the subject visit template exist, and some visits are the same in both template versions, then you can specify the same clinical item value. This feature allows both visits to have the same completion criteria in Oracle Health Sciences InForm.

Note: The clinical item value for a visit must be unique within a version of a subject visit template.

Activities - Clinical Item

When you create a visit activity, the clinical item in the Activities applet is populated with the value in the Activities Description field.

The clinical item value defines the completion criteria for the activity in Oracle Health Sciences InForm. The user often completes the same activity at multiple visits, therefore the user can assign the same clinical item value to each activity, and then define the completion criteria only once in Oracle Health Sciences InForm.

Note: The clinical item value for an activity must be unique within a visit in a version of a subject visit template.

About Exporting Data for Sites

Use the LS Clinical Protocol Site Interface Service Web service to export the data in the Protocol Site List view from Siebel Clinical Trial Management System to an external application. For information about the Protocol Site List view, see Creating Sites for Clinical Trials.

The following data is exported:

Account
Initiation completed date
Primary investigator
Protocol number
Region
Site number
Status

About Integrating Data for Activity Completion

Oracle Health Sciences InForm controls the integration of activity completion data between Siebel Clinical and Oracle Health Sciences InForm. In Oracle Health Sciences InForm, when patient data is entered that complies with the criteria for the clinical item value for a visit or activity, Siebel Clinical receives a message containing a completion date. The visit or activity is updated with the status of Complete, and the completion date is populated.

If the message from Oracle Health Sciences InForm does not contain a completion date, and the visit or activity in Siebel Clinical already has a status of Complete, then no change is made to the completion date or status in Siebel Clinical.

Oracle Health Sciences InForm integrates activity completion data with Siebel Clinical as follows:

Siebel Clinical searches for the subject using the unique subject identifier (row ID). When the subject is found, it searches for the activity as follows:
- Siebel Clinical searches for the activity using the clinical item for the visit and the clinical item for the visit activity as follows:
  - If the clinical item in the update corresponds to a subject visit, then the completed date for that visit is updated.
  - If the clinical item in the update corresponds to an activity for a subject visit, then the completed date for that activity is updated.
- If the clinical item sent from Oracle Health Sciences InForm cannot be mapped to an activity completion item in Siebel Clinical, then an error is generated to indicate that the update failed.