Pharmacovigilance Signal Detection: PRR, ROR, Chi-Square & Case Counts
Build the drug × event 2 × 2 table from spontaneous reports, compute PRR and ROR with confidence intervals and the Yates χ², flag signals, and review time to onset, reporting trends and case outcomes, on synthetic data in a live spreadsheet that checks every cell.
The first lesson is free — no account needed.
About this course
A pharmacovigilance course that screens the spontaneous reports of one fictional company, Halvern Pharma, for safety signals on synthetic data in a spreadsheet, for drug safety associates, pharmacovigilance scientists, pharmacists and pharmacy, medicine and epidemiology students. You count 50 reports into the drug-by-event 2×2 table with COUNTIFS, calculate the proportional reporting ratio of a fictional drug and pancreatitis with its 95% confidence interval, screen eight drug–event pairs with the reporting odds ratio, test a pair with chi-square with and without the Yates correction, apply the classic PRR ≥ 2, χ² ≥ 4, n ≥ 3 rule to ten pairs and colour the signals, summarise time to onset with the median and a histogram, follow quarterly reporting trends and the stimulated-reporting caveat, and summarise the case series by seriousness, outcome and dechallenge. Synthetic data and fictional drugs, with no regulatory agency affiliation. Educational only, not medical or regulatory advice. The first lab is free.
Lessons
- The 2 × 2 Table: Counting Drug × Event Reports with COUNTIFSFree
- Proportional Reporting Ratio (PRR) and Its 95% Confidence Interval Pro
- Reporting Odds Ratio (ROR) and Its Confidence Interval for Eight Pairs Pro
- Chi-Square with Yates Correction for a 2 × 2 Table Pro
- Signal Criteria: PRR ≥ 2, χ² ≥ 4, n ≥ 3 as Flags and Conditional Formatting Pro
- Time to Onset: Days from Start to Event, Median and a Histogram Pro
- Reporting Trends by Quarter and the Stimulated Reporting Caveat (Combo Chart) Pro
- Case-Level Review: Seriousness, Outcome and Dechallenge Summary Pro