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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:
|
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 |