Setting Up and Configuring Clinical Data Management System Integration

This chapter covers setting up and configuring Siebel Clinical for integration with a clinical data management system. It includes the following topics:

Overview of Clinical Data Management System Integration

The following integration processes facilitate clinical trial 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. A integration exists for Siebel Clinical and Oracle Health Sciences InForm that uses this Web service to create subjects in Siebel Clinical when screening or enrollment data is entered in Oracle Health Sciences InForm.
Activity completion data integration. The integration for Siebel Clinical and Oracle Health Sciences InForm uses a Siebel Clinical Web service to update the completion dates of visits and activities in the subject visit template. The customer configures trigger conditions in the Oracle Health Sciences InForm trial to send the completion date from Oracle Health Sciences InForm to Siebel.

The integration from Oracle Health Sciences InForm to Siebel Clinical automates the creation of subjects in Siebel Clinical and the completion of visits and activities.

The automation of these processes enables the timely and accurate payments to investigators. It also provides a means to more accurately track and respond to issues relating to site performance and protocol adherence.

For information about configuring Oracle Health Sciences InForm for integration with Siebel Clinical Trial Management System, see Oracle Health Sciences InForm Publisher On Demand 2.1 Integration Guide.

About Customizing Web Services for Clinical Data Management System Integration

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

Process of Setting Up Clinical Data Management System Integration

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

Activating Workflows for Clinical Data Management System Integration

This task describes how to activate the workflows that are required for clinical data 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 Management System Integration.

To activate workflows for clinical data 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 Management System Integration

This task describes how to configure the Web services that are required for clinical data 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 Management System Integration.

To configure Web services for clinical data 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.

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 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 is passed from Oracle Health Sciences InForm to Siebel Clinical when updating the visit or activity completion date. 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 for the activity is passed from Oracle Health Sciences InForm when sending the completion date for the activity. 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 is passed from Oracle Health Sciences InForm to Siebel Clinical when updating the visit or activity completion date. 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 for the activity is passed from Oracle Health Sciences InForm when sending the completion date for the activity.

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

About Integrating Data for Clinical Subjects

The customer defines events that invoke the Siebel Web service to create and update subject information. The event defines what data entry in Oracle Health Sciences InForm will cause Oracle Health Sciences InForm to call the Siebel Web service. When patients are assigned to patient positions in Oracle Health Sciences InForm, or patient data is entered for a patient position, the integration triggers the creation of a subject in Siebel Clinical. Updates to the information for the patient in Oracle Health Sciences InForm are exported to Siebel Clinical. Deleted data in Oracle Health Sciences InForm is not reflected in Siebel Clinical. Patient data for Oracle Health Sciences InForm and subject data for Siebel Clinical is integrated as follows:

Subject Messages. When a subject message is received by Siebel Clinical from Oracle Health Sciences InForm, Siebel Clinical evaluates it to determine if a new subject must be created or if an existing subject must be updated. Siebel Clinical searches for the system ID of the subject. If the system ID does not exist, then Siebel Clinical creates a new subject. If it does exist, then Siebel Clinical updates the subject.
Subject Number and Subject ID. Oracle Health Sciences InForm sends the subject number over as a Subject ID to Siebel Clinical.
Encounter Date. The customer decides which date from Oracle Health Sciences InForm to map to Encounter Date in Siebel Clinical, and configures the mapping accordingly.
Screen Date. The customer decides which date from Oracle Health Sciences InForm to map to Screen Date in Siebel Clinical, and configures the mapping accordingly.
Informed Consent Date. Informed Consent Date is required only if a new Subject Visit Template is being applied. If Siebel Clinical does not have an informed consent date, then an Effective Date (for the Subject View Template) is sent instead of an informed consent date.

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. The customer defines in the Oracle Health Sciences InForm trial what data must be collected to determine that a visit or activity in Siebel Clinical is complete. When those conditions are met, Siebel Clinical receives a message. 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 and Siebel Clinical integrate activity completion data 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.