Siebel Clinical Trial Management System Guide > Setting Up and Configuring Clinical Data Management System Integration >

About Integrating Data for Clinical Subjects

Oracle Clinical controls the integration of subject data between Siebel Clinical and Oracle Clinical. When patients are assigned to patient positions in Oracle Clinical, 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 Clinical are exported to Siebel Clinical. Deleted data in Oracle Clinical is not reflected in Siebel Clinical. Patient data for Oracle Clinical and subject data for Siebel Clinical is integrated as follows:

• Subject messages. When a subject message is received by Siebel Clinical from Oracle Clinical, 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.
• Enrollment Date Specified. If an enrollment date is entered for a patient in Oracle Clinical, then a subject is created in Siebel Clinical if it does not already exist, and the subject are enrolled using the active subject visit template for the protocol site.
• Enrollment Date Not Specified. When a patient has data entered in Oracle Clinical, but no enrollment date has been specified, a subject with a status of Screened is created in Siebel Clinical, and the subject is screened against the active subject visit template for the protocol site.
• Patient Initials. Siebel Clinical does not record the subject's initials, or any personally identifiable information. The Patient Initials field in Oracle Clinical is mapped to the Subject ID field in Siebel Clinical. The user must change the exported value in Siebel Clinical. Patient Initials is an optional field in Oracle Clinical. Subject ID field is a mandatory field in Siebel Clinical. If patient initials were not entered in Oracle Clinical, then the Subject ID field in Siebel Clinical is populated with the Oracle Patient Position ID.
• Birth Date. Siebel Clinical does not record the subject's date of birth, or any personally identifiable information. The patient's Birth Date field in Oracle Clinical is mapped to the Encounter Date field in Siebel Clinical. The user must change the exported value in Siebel Clinical. Birth date is an optional field in Oracle Clinical. Encounter Date is a mandatory field in Siebel Clinical. If birth date was not entered in Oracle Clinical, then the Encounter Date in Siebel Clinical is populated with a value of Jan 1, 1800.
• Screen Date. If no screening date is collected in Oracle Clinical, then the screening date is populated with the subject's birth date. Users must correct the Screen Date field in Siebel Clinical and screen the subject again using the correct screening date.
• Informed Consent Date. Informed Consent Date is required for enrolled patients in Siebel Clinical but is an optional field in Oracle Clinical. If no informed consent date is specified in Oracle Clinical, then the informed consent date is populated with a value of to Jan 1, 1900. The user must change any default informed consent dates in Siebel Clinical to reflect the date when the informed consent form was signed. Informed consent date is used when enrolling a subject against a new version of a subject visit template and must be accurate.