Seven Days and Fifteen Days

Part of Pharmacovigilance and Drug Safety (PV) Training: The Reporting Clock.

About 2 minutes. Free, in your language, no account needed.

Two clocks, decided by outcome

For expedited reporting from a clinical trial, the deadline depends on how bad the event was.

Seven calendar days for a SUSAR that is fatal or life-threatening. An initial report within seven days, with a follow-up report completing the picture within a further eight.

Fifteen calendar days for all other SUSARs.

Calendar days, not working days. A clock that starts on a Thursday before a public holiday does not pause.

What has to be true for the clock to run

Three conditions together:

• The event is serious
• It is assessed as having a reasonable possibility of a causal relationship
• It is unexpected against the applicable reference document

All three. A serious and related event that is listed in the RSI is not a SUSAR. A serious and unexpected event assessed as unrelated by both investigator and sponsor is not a SUSAR.

Post-marketing

For an authorized product, serious cases are generally reportable within fifteen calendar days regardless of expectedness. Non-serious cases are handled differently depending on where you are: in the European Economic Area they carry their own ninety day submission requirement, while elsewhere they may be captured through periodic reporting instead.

The detail differs between regions and is one of the areas where local requirements genuinely diverge. Know which rules apply to your product in which territory rather than assuming one set covers everything.

Incomplete does not mean late

A report that is due is submitted when it is due, with what you have. Missing information is noted as being sought and supplied in a follow-up. Holding a submission until the case is complete is how deadlines are missed.