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Account |
The name of the account associated with the product issue. |
E1 |
Address |
Account address - street address. |
E1 |
Alert Age |
The number of days since the product issue was identified as reportable. If an initial report has been filed, the alert age is the number of days that the product issue was marked reportable before the report was filed. |
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Alert Date |
The date when a representative of a company becomes aware that the event needs to be reported. For example, when:
- A call center agent captures the adverse event or complaint.
- An assessment indicates that the event is reportable.
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Area |
The general categorization area for the product issue. This field is constrained by Type. |
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City |
Account address - city. |
E1 |
Contacts (Contact Last Name in list) |
The last name of the customer contact associated with the product issue. These contacts can also be entered using the Contacts view of the Product Issues screen > Contacts view. |
E1 |
CSN |
Customer service number. A unique number to identify the account. |
E1 |
Evaluation |
This field appears in the list applet. It also appears in the form in the Investigation view. |
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First Name |
The first name of the investigator carrying out a particular clinical trial at a site. |
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First Name (Contact First Name in list) |
The first name of the customer contact associated with the product issue. |
E1 |
Investigator |
The last name of the investigator carrying out a particular clinical trial at a site. If the product issue is associated with a clinical trial, this field is auto-populated with the last name of the investigator at the protocol site, specified in the Protocol number field. |
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Mfg Report # |
This field appears in the list applet. It also appears in the form in the Importer view. |
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Occupation |
Occupation of the contact. This is copied from the value of the Type field in the Contacts screen. |
E3 |
Open Age |
The number of days since the product issue was opened, or, if the product issue is closed, this is the number of days that the product issue was open. |
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Phone # |
Contact's work phone number. |
E1 |
PI # |
Unique number to identify the product issue. It is auto-generated when the product issue is created. |
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Postal Code |
Account address - postal code. |
E1 |
Protocol # |
Protocol number identifies the clinical trial at a site. If regulatory report is an IND safety report, enter the protocol number. |
G6 |
Provider |
Indicates if the contact is a health professional. |
E2 |
Received (Received Date in the list) |
The date when a company representative became aware of the event. |
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Reported FDA |
Indicates if initial reporter sent a report to the FDA. |
E4 |
SR # |
The service request from which the product issue was created. |
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State |
Account address - state. |
E1 |
Status |
The current status of the product issue. The status of the product issue can be changed by the owner of the product issue, using the Review Complete, Close, and Reopen buttons. Changes to this field are tracked in the Approvals view. |
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Sub Area |
This further refines the area categorization. (The Area field constrains this drop-down list.) |
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Sub Status |
The Status field constrains this drop-down list. |
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