Question 10 of 20 Intermediate Interpretation
When does the clock start for reporting an individual case safety report?
Short answer
Day zero is the first day anyone in the company, including medical representatives and contractors, receives the four minimum criteria for a valid case. In the EU, serious cases are due within 15 calendar days and non-serious EU cases within 90. In the US, serious and unexpected postmarketing cases are due within 15 calendar days.
Why
GVP Module VI says the clock starts when information containing the minimum criteria reaches any personnel of the marketing authorisation holder, including sales staff and contractors, and that weekends and holidays count. The minimum criteria are an identifiable reporter, an identifiable patient, a suspected product and a suspected reaction. So a sales representative who hears about a hospitalization on Friday evening has started the clock on Friday, even if the safety team learns of it on Tuesday.
Significant follow-up restarts the clock for the follow-up report. For literature, day zero is awareness of a publication containing the minimum criteria. US postmarketing rules differ in scope: 21 CFR 314.80 requires 15 day alert reports for events that are both serious and unexpected, with others reported periodically.
Contracts with partners and vendors must define exchange timelines short enough that the company still meets its own deadline. A case that arrives at a distributor and sits for a week has used half its time before the safety team sees it.
A strong answer covers
- Day zero at first receipt by anyone in the organization
- Four minimum criteria for a valid case
- EU 15 days serious, 90 days non-serious
- US 15 day alerts for serious and unexpected
- Follow-up restarts the clock, partners need tight exchange terms
Common mistakes
- Starting the clock when the safety department receives the case.
- Excluding weekends and public holidays from the count.
- Assuming EU and US expedited criteria are identical.
The interviewer might ask next
How would you set the safety data exchange timeline in a licensing agreement?