Submit your report

When you've completed entering information for your safety report 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.") you can proceed to submission.

How the Portal That is, the "Safety Reporting Portal" application. handles your report:

When you indicate that you’re ready to submit your report, the Portal system performs several processes:

1. Validates that all minimally required information is present in your report (enough so that US Government analysts can take action on your report). If required information is missing, the system will provide you with an alert An onscreen notification to the user from the Safety Reporting Portal system.

2. Changes your report from Draft status to Submitted status. If you have created a Portal user account and are logged in, you will see that your report has been moved out of your list of draft reports, and into the list of submitted reports. To view the list of your reports, click the My Reports link in the left menu.

3. Creates a PDF version of your report that you can view, print, or save to your local desktop computer or network.

4. Assigns a reference identifier (ICSR Individual Case Safety Report--is a Health Level Seven (HL7) standard for the capture of the information needed to support the reporting of adverse events, product problems or consumer complaints associated with the use of regulated products. number) and electronically transmits your report to one or more US Government agencies, as appropriate.

 Please note:  Once you have submitted your Safety Report, no further changes are permitted. If later you need to change or add information to a report, submit a follow-up report.

Once you create and submit a follow-up report, the originally submitted report is removed from the Submitted Reports Available for Follow-Up list and you will no longer be able to view your originally submitted report. We recommend that when you are submitting a safety report that you always create and save a .pdf of your submitted safety reports.

Refer also to related Help topics:

• Create a Safety Report

• Begin a report and complete it later

• Submit a follow-up report

• Find a saved report

• Print your Safety Report

• Save an electronic copy of your Safety Report