What Arrives, and From Where

Part of Pharmacovigilance and Drug Safety (PV) Training: What the Safety Desk Is For.

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

Four sources, four characters

Clinical trials. Events reported by investigators on a study you are running. These arrive structured, usually through the site or the data management system, and the reporter is a clinician who has assessed the participant.

Spontaneous reports. A patient, a family member, a pharmacist or a doctor contacts the company or a regulator directly, without being asked. These are the backbone of post-marketing safety and the least complete. A spontaneous report may be three sentences in an email.

Literature. A published case report or study describing an event with your product. Somebody has to be reading the literature systematically for this to arrive at all.

Solicited sources. Patient support programs, market research, surveys, digital platforms. These were once treated casually. They are not exempt.

The difference that matters

Trial cases and spontaneous cases are assessed differently in one important way. In a trial, the investigator gives a causality assessment and there is a protocol, a reference document and a known dose. In a spontaneous report you may not know the dose, the indication, or whether the person took the product at all.

That does not make the spontaneous report less important. It makes it harder, and it is where most of the judgment in this job lives.

Nothing is beneath your attention

A report that arrives badly, in the wrong channel, from someone who is angry and imprecise, is still a report. The signal that first reveals a serious problem is rarely well presented. Treat the poorly formed report as seriously as the tidy one.