If I have submitted any type of report via the previous version of the RFR reporting system, will I be able to access these reports and submit an amended report in the Safety Reporting Portal?
No. This is due to validation, authentication, and other technology limitations. Previous versions of the RFR reports cannot be loaded into the Safety Reporting Portal. If you need to amend an RFR report that was previously submitted to FDA in the earlier version, please consult FDA by calling your assigned investigator, or your FDA district office. If you are required to amend your report after consultation with FDA, you will need to re-submit the latest information (including information that was captured in the previous version of the RFR system) to the Safety Reporting Portal and provide a statement in the narrative field with the following verbiage “This is an amended report to ICSR xxxxxxx.”, replacing the ‘xxxxxxx’ with the ICSR number that you originally received.
