The Case That Does Not Expedite

Part of Pharmacovigilance and Drug Safety (PV) Training: What Does Not Expedite.

About 1 minutes. Free, in your language, no account needed.

Not everything serious is expedited

A case can be serious, thoroughly documented and genuinely important, and still carry no expedited obligation. Understanding why prevents two opposite errors: reporting everything, which buries the authority in noise, and treating a non-expedited case as unimportant.

The common combinations

Serious, related, expected. A listed adverse reaction occurring as described. It goes into the aggregate report, not an expedited one.

Serious, unexpected, unrelated. A participant is hit by a car. Serious, certainly not in the Investigator's Brochure, and not caused by the product.

Non-serious, unexpected, related. A new but mild reaction. It matters for the eventual label and it is not expedited.

Unrelated is the one to be careful with

Of these, the unrelated determination is the one that deserves scrutiny, because it is the one that can be reached too easily. A plausible alternative explanation is not proof that the drug was not involved. Both can be true.

Where the case is genuinely arguable, remember the standard: a reasonable possibility is enough to meet the causality criterion.

Non-expedited is not unexamined

A case that does not expedite still gets processed, coded, narrated where required, and entered into the database. It counts in the aggregate reports and it counts in signal detection.

The distinction is only about the reporting clock. It is not a statement about the value of the case, and the language people use around it, "just a non-serious one", is worth resisting for exactly that reason.