Any adverse-event report, product problem or complaint report, as well as a product-use error report. The safety report is also known in the Portal as a \"submission.\" (See also \"ICSR.\")
A user session (also referred to as a visit) is the presence of a user with a specific IP address who has not visited the site recently (typically, anytime within the past 30 minutes). (Thus, a user who visits a site at noon and then again at 3:30 pm would count as two user visits.)
Any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
A completed report that has been submitted through the Portal, and may no longer be edited. (For registered users, the report will appear in the list of Submitted Reports, under \"My Reports.\" Compare to \"Draft Safety Report.\")
Documentation apart from information that’s added directly into the report. Examples are product labels, bills of lading, relevant laboratory reports. In electronic form, these may be uploaded through the Safety Reporting application.