Siebel Life Sciences Guide > Setting Up and Configuring Safety System Integration >

Logging a Product Issue for Safety System Integration

This task describes how to create a product issue in the Product Issues screen. To create a product issue from a service request, see Capturing Adverse Events and Complaints as Service Requests.

This task is a step in Process of Setting Up Safety System Integration for Siebel Medical.

To log a product issue for safety system integration

1. Navigate to the Product Issues screen, then the Product Issue view.
2. In the Product Issue List, create a new record and complete the necessary fields for the integration.

   Some fields are described in the following table.

   Name	Description	Required
   AE Case ID	This field is populated with the adverse event case ID when the case is accepted by the safety system.	No
   Awareness Date	The date the company was made aware of the event.	Yes
   Country of Incidence	This list of values displays the countries that are configured in Siebel CRM.	Yes
   Description	Detailed description of the adverse event.	Yes
   Event Type	Describes the type of event, such as adverse drug event or adverse, medical-device event.	Yes
   Event Severity	This field captures the severity of the product issue. The following list of values is provided: Mild Moderate Severe	No
   Last Follow Up Date	This field displays the date that follow-up information on the adverse event was last recorded.	No
   Product	The name of the product associated with the adverse event.	Yes
   Received Date	The date when a company representative became aware of the event.	No
   Reportable	Set this field to one of the following values: Yes No Potential Follow Up Void	Yes
   Reported Outcome	This field captures the reported outcome for the product issue. The following list of values is provided: Recovered Recovering Not Recovered Resolved with Sequelae Fatal Unknown	No
   Reporter Qualification	This field captures whether the reporter is a health professional, lawyer, or consumer. The following list of values is provided: Physician Pharmacist Other Health Professional Lawyer Consumer or Non-Health Professional	No
   Report Type	This field captures whether or not the product issue was reported during a study. The following list of values is provided: Spontaneous Study Other Not available to Sender	Yes
   Safety System Received Date	This field is populated with the date when the case was accepted by the safety system.	No

3. (System) The product issue Status field is set to Open by default.