Day Zero
Part of Pharmacovigilance and Drug Safety (PV) Training: Intake and Triage.
About 2 minutes. Free, in your language, no account needed.
The clock does not start when you open the file
The reporting clock starts on the day the first person in your organization, or anyone acting on its behalf, became aware of a report meeting the minimum criteria. That is day zero.
Not the day it reached the safety database. Not the day it was assigned to you. The day somebody knew.
Who counts as your organization
This is wider than people expect. It includes:
- Your own staff, in any department
- A contract research organization working on your study
- A distribution partner or licensee, depending on the agreement
- A call center taking product complaints
- A medical information line
A serious event described to a sales representative on a Friday, mentioned to a manager on Monday and entered into the safety system on Wednesday has a day zero of Friday. Two days of a fifteen day clock are already gone before anyone in safety has seen it.
Why companies get this wrong
Because the information sits somewhere that does not think of itself as safety. Medical information, customer complaints, quality, legal, social media monitoring, a clinical operations mailbox. Each one handles its own work well and does not always recognize that an adverse event has just crossed its desk.
The fix is not cleverness in the safety department. It is that every one of those functions is trained to forward, and that the forwarding is measured.
Recording it honestly
When you establish day zero as earlier than the date the case reached you, record it as such. The instinct to date the clock from your own awareness makes the metrics look better and the submission late. A late report that is dated honestly can be explained. A report dated to hide lateness is a different kind of problem.