Enabling Patient and Subject Activity Integration

In this section:

• Enabling Integration at the Database Level
  
• Overriding Default Integration Values for Individual Studies
  

Enabling Integration at the Database Level

You can make two types of Oracle Clinical information available to another application: Patient Positions and Subject Activities.

You set the default values for new studies at the database level and, if required, override the default values for individual studies.

Note:

Setting or changing these values does not affect existing studies.

To set the default values at the database level:

1. Go to the Admin menu and then click Integration Database Settings. The Integration Database Settings window opens.
2. Click the Integration Settings node (+).
3. Enter values:

   • Enable Patient Integration? If set to Y, Patient Integration is enabled by default for new studies. Oracle Clinical writes information about a patient position to a queue, where it is available to send to other applications. For each patient position, this occurs for the first time when a patient is assigned to a patient position: when the enrollment date, informed consent signature date, or first CRF is entered for the patient position. Oracle Clinical also writes any subsequent updates for a patient position in the patient_positions table or patient_statuses table, or a change in the patient position's study site assignment, to the queue.

     If set to N, Patient Integration for studies is not enabled by default. This is the shipped value. If set to Y, Patient Integration is enabled by default.

   • Enable Subject Activity Integration? If set to Y, Subject Activity integration is enabled by default for new studies. You can define completion criteria in Oracle Clinical so that patient data collected in Oracle Clinical or RDC can signal visit/activity completion in a clinical trial management system (CTMS); see Setting Up and Using Activity Completion Integration.

     If set to N, Subject Activity Integration is not enabled by default. This is the shipped value. If set to Y, Subject Activity Integration is enabled.

     Note:

     In order to use Subject Activity Integration in the Siebel Clinical integration, you must set both values to Y. It is possible to set Enable Subject Activity Integration? to Y and Enable Patient Integration? to N, but the integration will not work unless both values are set to Y.

4. For each setting you can select Enforce Local DB Setting or not:

   • If selected, all new Studies are created with the value for the setting that you specify here and the value cannot be changed at the study level.

   • If unselected, all new Studies are created with the value for the setting that you specify here and the value can be changed at the study level.

5. Save.

Overriding Default Integration Values for Individual Studies

To override the default values for a particular study:

1. Go to the Design menu and then click Integration Study Settings. The Integration Database Settings window opens.
2. Click the Integration Settings node (+).
3. Enter values:

   • Enable Patient Integration? If set to Y for this study, Oracle Clinical writes information about a patient position to a queue, where it is available to send to other applications. For each patient position, this occurs for the first time when a patient is assigned to a patient position: when the enrollment date, informed consent signature date, or first CRF is entered for the patient position. Oracle Clinical also writes any subsequent updates for a patient position in the patient_positions table or patient_statuses table, or a change in the patient position's study site assignment, to the queue.

     If set to N, Patient Integration is not enabled for the study. If set to Y, Patient Integration is enabled for the study.

   • Enable Subject Activity Integration? If set to Y, you can define completion criteria in Oracle Clinical so that patient data collected in Oracle Clinical can signal visit/activity completion to a clinical trial management system (CTMS); see Setting Up and Using Activity Completion Integration.

     If set to N, Subject Activity Integration is not enabledfor the study.

     Note:

     In order to use Subject Activity Integration, you must set both values to Y.

4. The Inherit from Local DB indicates whether or not the setting is inherited from the database level:

   • If selected, the setting is inherited. If you can deselect it, the setting is not enforced and you can change the value.

   • If unselected, the setting is not inherited. You can select it if you want to be sure you are using the default setting. You can change the setting as required for your study.

5. Save.