Periodic Reporting

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

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

Aggregate reports do the other half of the job

Expedited reporting handles the single alarming case. Periodic reporting handles the accumulated picture: what has been seen across all the cases, in the context of how much the product has been used.

Both are necessary. Neither substitutes for the other.

The main reports

DSUR, the Development Safety Update Report, for products in clinical development. Annual, timed from the development international birth date, covering the safety experience across the whole program.

PBRER, the Periodic Benefit-Risk Evaluation Report, for authorized products. The successor to the PSUR format, and its title states its purpose: this is a benefit-risk assessment, not a list of adverse events.

PADER in the United States, on its own schedule and in its own format.

What makes them different from a stack of cases

An aggregate report has a denominator. Thirty cases of a given event means one thing in a population of five hundred patients and something entirely different in a population of five hundred thousand.

It also has a narrative: what the company now believes about the product's safety profile, what has changed since the last report, and what it proposes to do.

Where your case processing shows

Every aggregate report is built from the cases you processed. Inconsistent coding turns one clinical event into four separate terms, each too infrequent to notice. Missing outcomes make seriousness patterns unreadable.

The aggregate report is where the quality of individual case processing becomes visible, and by then it is too late to improve it.