Expedited reporting
In Safety & pharmacovigilance
Expedited reporting is the fast-track submission of specific safety cases to regulators and, where required, to ethics committees and investigators. The clock starts the moment anyone at the organization first becomes aware of a case that meets the criteria. Timelines are counted in calendar days, not working days.
Example
A site tells the sponsor on a Friday about a fatal unexpected reaction. Day zero is that Friday, and the seven-day clock for the initial report to the authority starts then, weekend included.
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