A case is valid, and Day 0 can start, when the organization has an identifiable patient, an identifiable reporter, a suspect product, and a suspect reaction. ICH E2D and EU GVP Module VI use that gate. If one of those is missing, the report is recorded and followed up. It is not ready to go forward as a valid case.
Coding, medical review, an E2B file, and signal statistics all use the case intake produced. When intake is late, those steps start late. When intake never collects the minimum criteria, they never see a valid case. Regulators tied the expedited clock to first valid knowledge, which is why the quality of the first report matters before any safety database is opened.
That is a process description. It is not an estimate of deaths following from a late report. No source on this page provides that number, so this page does not offer one.
Why AE Connect is the step before the safety database
AE Connect is a structured intake form plus an AI draft. A reviewer accepts or overrides each field. The case can go to the safety database the company already uses, including Oracle Argus, ArisGlobal LifeSphere, or Veeva Vault Safety, or AE Connect can hold the ICSR and the E2B(R3) file. AE Connect does not submit or transmit ICSRs.
The draft is there so the minimum facts, seriousness, and a suggested coding are visible while the case is still at intake. It does not make the regulatory call, and nothing on this page is a claim that the software changes mortality.