Two Opinions, Kept Apart

Part of Pharmacovigilance and Drug Safety (PV) Training: Causality.

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

Whose assessment is this

In a trial, the investigator assesses causality because they examined the patient. The sponsor assesses it because it sees every case across every site and knows the product.

Both are recorded. Neither overwrites the other.

When the sponsor disagrees

A sponsor may reach a different conclusion, and may say so. What a sponsor may not do is substitute its assessment for the investigator's in order to avoid an obligation.

For expedited reporting in a clinical trial, if either the investigator or the sponsor considers there is a reasonable possibility of a causal relationship, the causality criterion is met. The more conservative view governs the obligation.

In the post-marketing world

A spontaneous report carries an implicit causal suspicion: someone thought the product was involved enough to report it. Many jurisdictions treat spontaneous reports as implying at least possible causality for reporting purposes, even where the reporter offered no assessment.

The absence of a stated causality on a spontaneous report is therefore not a reason to treat it as unrelated.

Unassessable is a real answer

Where the information is too sparse to support any judgment, unassessable is honest and is sometimes correct. It should be uncommon. If most of your cases are unassessable, the problem is usually in follow-up rather than in the events.

Write down the reasoning

A causality category with no supporting rationale is difficult to defend and impossible to review. The considerations you weighed, including the alternative explanations you rejected and why, belong in the case.