Periodic reports from the case data you already hold
Aggregate reports look at the safety of a product over a period rather than case by case. They take time to prepare because the same case data has to be pulled, counted, tabulated and checked again for each report. In Edriza the cases are already structured and coded in MedDRA, so the data sections of an aggregate report can be built straight from them, and your experts can spend their time on the evaluation.
The reports covered
- PBRER (Periodic Benefit-Risk Evaluation Report), the format described in ICH E2C(R2). In the European Union it is the format of the PSUR under GVP Module VII.
- PSUR (Periodic Safety Update Report), required by many authorities for marketed products, in the PBRER format or a local variant.
- PADER (Periodic Adverse Drug Experience Report), the periodic report for approved applications in the United States.
- DSUR (Development Safety Update Report), the annual report for investigational products described in ICH E2F.
What Edriza prepares
- A calendar of due dates per product and territory, with the data lock point of each report.
- The case set for the reporting interval and cumulatively, taken from the case database.
- Line listings and summary tabulations of adverse reactions by MedDRA system organ class and preferred term, serious and non-serious.
- Counts and listings of the cases of special interest your SOP names.
- A draft of the report for your experts, with every figure traceable to the cases behind it.
The benefit-risk evaluation and the conclusions remain your experts' work. Edriza drafts; your team reviews, edits and signs off, and the sign-off is recorded in the audit trail with the person and the time.
Consistency between reports
Because every report draws on the same case database, a figure in a PSUR, in a DSUR and in a signal review comes from the same data. When a case is corrected after a follow-up, the next report uses the corrected version, and the history of the change stays visible. This avoids a common inspection finding: tables that cannot be reconciled with the safety database.
Signals and aggregate reports
Periodic reports summarise the signals that were open, closed or evaluated during the interval. Edriza's signal management keeps those signals in the same platform, so the signal section of a report reflects the signal tracker rather than a separate spreadsheet.
Where the cases come from
The case data behind every report is processed in Edriza from any source: literature, local journals, the mail box, intake ICSRs and uploaded documents. See ICSR case processing and E2B(R3) submission for how each case is checked, and literature monitoring for how articles are screened.
Part of one platform
Aggregate reporting is one of the modules of the same platform as case processing and signal detection, with no separate tool or subscription. Contact us to discuss the reports you prepare each year.