SAE reconciliation

How events are paired, what is compared and how comments carry over.

SAE reconciliation compares the serious AE listing from the safety database (Argus, ARISg, a CIOMS line listing or Excel) with the AE listing from the EDC. It is usually done line by line by hand before every DSUR and before database lock.

How events are paired

For each subject, events are paired by a cascade of keys, strictest first. Subject numbers are compared without separators and prefixes, so "101-001", "101 001" and "S-101-001" are the same subject.

same term and same onset date;
same term, onset within the window (±2 days by default);
same term, one side has no onset date;
similar term (typos, word order, abbreviations such as MI, AF, PE), onset within the window;
dates overlap but the terms differ. Such a pair is flagged: check that it is the same event.

Case and wording are not discrepancies: "Possibly related" and "POSSIBLE" both mean related, "Grade 3" and "Severe" mean the same severity, "Recovered" and "RECOVERED/RESOLVED" mean the same outcome.

What is compared

Seriousness, onset and end dates, severity, causality, outcome and action taken, when both listings have the column. Differences in seriousness, onset, causality and outcome are critical, and so are events found in one database only. By default only serious AEs are taken from the EDC. Untick it to compare all AEs and catch a non-serious EDC event that safety holds as serious.

Rounds and comments

The discrepancy sheet of the Excel report has Status, Owner and Comment columns for your notes. In the next round, upload that file as "Last round’s report". Your notes follow the same discrepancies, and discrepancies that are gone are listed as resolved since the last round. Each discrepancy has a stable ID built from the subject, the event and the attribute.

Try it

Example files: safety_sae_listing.csv, edc_ae_listing.csv. Upload the first file as the safety listing and the second as the EDC listing. You will see an SAE missing in the EDC, an onset date that differs by a few days, different causality and outcome, and a pair matched by a similar term.

Sources

ICH E6 (GCP) and E2A: expedited reporting and safety data.
SCDM, Good Clinical Data Management Practices: SAE reconciliation chapter.

Nothing is stored. Files are read in memory and discarded; the audit trail records counts only. The report holds subject data: keep and send it under your study’s rules. This is a working tool; the reconciliation outcome is approved in your own quality system.