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
Navigate to the Product Issues screen, then the Product Issue view.
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
-
(System) The product issue Status field is set to Open by default.