Definition

The initiation of the regulatory reporting timeline, triggered when minimum criteria for a reportable case are met. The clock determines the deadline for submitting expedited or periodic reports.

Example

A company receives partial information on Day 0. On Day 3, they receive the final piece confirming a valid, serious case. The clock starts on Day 3, and a 15-day expedited report would be due by Day 18.

Regulatory source

ICH E2D, 21 CFR 314.80

Common mistakes

Starting the clock before having all four minimum elements. The clock only starts when you have a valid, reportable case.

Inspector question

Show me an example where the clock start date differs from the initial receipt date and explain your rationale.

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