Individual Case Safety Reports tell you about single events. Aggregate reports do something different: they step back and summarise everything known about a product's safety over a defined period, so regulators can assess the overall benefit-risk picture. If you are new to the single-case side first, see our guide to ICSR case processing. This article covers the periodic reports that sit on top.
Why aggregate reporting exists
No single case proves a safety concern. Patterns emerge only when you look across many cases, alongside clinical trial data, literature, and exposure estimates. Aggregate reports are the formal mechanism for that periodic review, and each major report type serves a different stage of a product's life — from clinical development to the post-marketing phase.
DSUR — Development Safety Update Report
The DSUR (ICH E2F) is the main periodic safety report during clinical development. It provides an annual review of the safety information collected for an investigational drug, focusing on whether the information is in line with previous knowledge and whether it affects the trial participants' safety. It is typically prepared annually from the development international birth date.
PBRER / PSUR — Periodic Benefit-Risk Evaluation Report
Once a product is on the market, the periodic report is the PBRER (ICH E2C(R2)), which in the EU is submitted as the PSUR. The two terms are often used interchangeably: PBRER is the ICH format, and PSUR is the regulatory submission built from it. Its defining feature is the benefit-risk focus — it does not just list adverse events, it evaluates whether the product's benefits continue to outweigh its risks in light of cumulative data.
PADER — Periodic Adverse Drug Experience Report
The PADER is the FDA's traditional US post-marketing periodic report. It is more of a case-listing-based format than the benefit-risk narrative of the PBRER. Some products report to the FDA via the PBRER format by agreement, but the PADER remains in use and is worth understanding for US obligations.
| Report | Stage | Standard | Focus |
|---|---|---|---|
| DSUR | Clinical development | ICH E2F | Annual safety of investigational drug |
| PBRER / PSUR | Post-marketing | ICH E2C(R2) | Benefit-risk evaluation |
| PADER | Post-marketing (US) | FDA | Periodic case listings / summaries |
What goes into an aggregate report
- Line listings and summary tabulations of cases over the reporting period
- Cumulative and interval data on exposure and events
- Signal and risk evaluation, linking to any detected signals
- Changes to the reference safety information
- An overall benefit-risk assessment (for PBRER/PSUR)
Much of this data is the same information used in signal detection, which is why integrated platforms reuse case data across both. Generating line listings and tabulations by hand is slow and error-prone; aggregate reporting software produces them directly from the case database.
How aggregate reporting software helps
A capable platform supports DSUR and PBRER/PSUR generation with line listings, summary tabulations, and scheduled or ad-hoc report runs, reusing data across outputs so the same cases do not have to be re-extracted for each report. The practical payoff is consistency — the numbers in the report match the case database — and far less manual assembly. PVgenix includes aggregate reporting with DSUR and PBRER/PSUR support, line listings, and summary tabulations as part of the broader safety lifecycle.
Frequently asked questions
PBRER is the ICH E2C(R2) format for the periodic benefit-risk evaluation report; PSUR is the regulatory submission built from it, particularly in the EU. The terms are often used interchangeably.
The DSUR is the periodic safety report during clinical development, typically prepared annually from the development international birth date under ICH E2F.
The PADER is the FDA's traditional US post-marketing periodic adverse drug experience report, based more on case listings than the benefit-risk narrative of the PBRER.