ICH Reporting Timelines Flashcards
Fatal or Life-Tberatening Unexpected ADRs
as soon as possible but no later than 7 calendar days after first
knowledge by the sponsor that a case qualifies, followed by as complete a report as possible
within 8 additional calendar days
Think: “7 Days to Save”
“7” links to the 7 working days.
“Days” keeps the time frame in focus.
“Save” emphasizes the urgency and the serious nature of reporting fatal or life-threatening ADRs (to potentially save lives).
Serious, unexpected reactions (ADRs) that are not fatal or life-threatening
Must be filed ASAP, but no later than 15 calendar days after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting
THINK: “15 Serious Days”
“15” directly links to the 15 calendar days.
“Serious” reminds you of the seriousness of the ADR (but not fatal or life-threatening).
“Days” keeps the focus on the time frame.
You can also imagine a calendar with 15 highlighted a
