Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Good Morning,  

What are your practices when considering 'Day Zero" during review of SAE data for expedited reporting criteria?  The US FDA regulations states:

"Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and, therefore, must be reported more rapidly to FDA (21 CFR 312.32(c)(2)). The requirement for reporting any unexpected fatal or life-threatening suspected adverse reaction to FDA is no later than 7 calendar days after the sponsor's initial receipt of the information (21 CFR 312.32(c)(2)). If the safety report submitted within 7 calendar days is complete, an additional submission within 15 days from day zero is not required."

If SAE data is received from primary source, and it is deemed as possible SUSAR, but additional information needs to be obtained from the primary source to verify that determination, is industry practice to consider Day Zero the day of initial SAE receipt, or the day the additional information is received that verifies for the reviewers that the SAE meets 7 or 15 day reporting SUSAR?  I have seen both interpretations, one resulting in more sensitivity in reporting SUSARs (which I would think is what the FDA has in mind with the regulation) and the other more specificity.  I would appreciate feedback from this broader audience of informed regulatory professionals.  Thank you!

This message was posted by a user wishing to remain anonymous

My understanding is that Day Zero is the day of the initial SAE receipt. Remember that the minimum requirements for the report are: an identifiable reporter, and identifiable patient, and adverse reaction and a suspect product. You would then issue a follow-up report once you receive the additional information. If you deem that causality is not related to the drug then that would be part of your follow-up report.
Original Message:
Sent: 31-Dec-2018 07:45
From: Anonymous Member
Subject: "Day Zero" when considering SAEs for Expedited Reporting to FDA/other regulatory bodies

This message was posted by a user wishing to remain anonymous

Good Morning,

What are your practices when considering 'Day Zero" during review of SAE data for expedited reporting criteria?  The US FDA regulations states:

"Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and, therefore, must be reported more rapidly to FDA (21 CFR 312.32(c)(2)). The requirement for reporting any unexpected fatal or life-threatening suspected adverse reaction to FDA is no later than 7 calendar days after the sponsor's initial receipt of the information (21 CFR 312.32(c)(2)). If the safety report submitted within 7 calendar days is complete, an additional submission within 15 days from day zero is not required."

If SAE data is received from primary source, and it is deemed as possible SUSAR, but additional information needs to be obtained from the primary source to verify that determination, is industry practice to consider Day Zero the day of initial SAE receipt, or the day the additional information is received that verifies for the reviewers that the SAE meets 7 or 15 day reporting SUSAR?  I have seen both interpretations, one resulting in more sensitivity in reporting SUSARs (which I would think is what the FDA has in mind with the regulation) and the other more specificity.  I would appreciate feedback from this broader audience of informed regulatory professionals.  Thank you!