Who Decides, and What Happens Next

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

About 2 minutes. Free, in your language, no account needed.

Two assessments, both recorded

In a clinical trial, the investigator assesses seriousness and the sponsor also assesses it. Both are kept. They do not always agree.

The rule when they disagree

For reporting purposes, the more conservative view prevails. If either the investigator or the sponsor considers the event serious, it is handled as serious.

A sponsor may not downgrade an investigator's assessment of seriousness in order to avoid a reporting obligation. The sponsor may record a differing opinion, and should, but the obligation follows the more cautious assessment.

What seriousness triggers

Seriousness is the gate to nearly everything downstream:

• A serious case gets an expedited assessment rather than joining the routine queue
• A serious, related and unexpected case in a trial becomes a SUSAR with a short clock
• A serious case usually requires a written narrative
• Follow-up on a serious case continues until the outcome is known or the trail is exhausted

Reclassification

A case can change. An event initially reported as non-serious becomes serious when the patient is admitted two days later. When that happens, the case is upgraded and, if it now meets the criteria for expedited reporting, a clock starts on the day you learned of the new information.

The reverse also happens, and is more delicate. Downgrading a case from serious to non-serious requires a documented reason and a reviewer. It is not an administrative correction.

Never leave it blank

An unassessed seriousness field defaults to nothing, which in practice means the case sits in the routine queue. Of all the fields in a case, this is the one where silence is most expensive.