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.
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What you'll build
What you will be able to do
Each lab ends with a concrete result that you build yourself and the checker confirms, cell by cell.
- Turn a list of 50 spontaneous reports into the 2 × 2 table behind every disproportionality statistic, with one COUNTIFS per cell, and reconcile it with the list.
- Calculate the PRR for Velorantib and pancreatitis, its standard error on the log scale and the 95% confidence limits.
- Screen eight drug–event pairs at once: the ROR, its log-scale standard error and the 95% limits, then count the pairs whose lower limit is above 1.
- Test whether Corimide and hepatitis are reported together more often than chance: expected count, χ² with and without Yates' continuity correction, and the p-value.
- Apply the classic three-part screening rule to ten drug–event pairs, count how many criteria each pair meets, flag the signals and colour their rows.
- Calculate the time to onset for 30 Velorantib–pancreatitis cases, summarise it with the median and quartiles, bin it into onset windows and chart the distribution.
- Follow pancreatitis reports for Velorantib over eight quarters: the share of all reports, the cumulative count, the jump after a media story, and a combo chart.
- Summarise the 24 well-documented Velorantib–pancreatitis cases the way a signal assessment report does: share of serious cases, median age, outcomes and dechallenge.
About this course
Spontaneous adverse event reports are screened for signals using a few standard statistics. This course lets drug safety staff and students compute them transparently. You count drug-event combinations into a two-by-two table with COUNTIFS, then calculate the proportional reporting ratio and the reporting odds ratio with confidence intervals for several pairs. A Yates-corrected chi-square completes the classic screening statistics, and you combine thresholds on PRR, chi-square and case count into flags with conditional formatting. Time-to-onset analysis gives medians and a histogram, and quarterly reporting trends illustrate the stimulated reporting caveat. The last lab summarises case-level seriousness, outcome and dechallenge. Training on fictional data; not a regulatory tool.
Curriculum
Course content
8 lessons · 8 labs · 1.9 h · final exam
- Unlocked when you buy the course
- Unlocked when you buy the course
- Unlocked when you buy the course
- Unlocked when you buy the course
- Unlocked when you buy the course
- Unlocked when you buy the course
- Unlocked when you buy the course
- Unlocked when you buy the course
- Final exam
Certificate
Finish with a certificate you can verify
Complete every lesson and pass the final exam to receive a certificate of completion for this course, with a unique credential ID and a public verification page.
- Names the course, your score and the date of issue
- A verification link for your CV or LinkedIn profile
- 12 questions, 75% to pass, unlimited retries.
A Tutorvo certificate confirms that you completed a course. It is not an official or professional qualification.
Before you buy
Questions about this course
Is this a subscription?
No. You pay $9.99 once for this course. There is no subscription and nothing renews automatically. Prices are in US dollars; taxes may be added where required.
What exactly do I get?
All lessons and labs of this course, the final exam and the certificate, including later updates to the course, for as long as Tutorvo offers it. Access is personal and tied to your account.
Can I get a refund?
Yes. If you are not satisfied, email hello@tutorvo.com within 14 days of buying and we refund the course in full via Stripe. The guarantee does not apply once a certificate for the course has been issued to you, or where there are signs of abuse.
When can I start?
Right after payment. Access starts immediately at your request; for consumers in the EU/EEA the statutory right of withdrawal therefore ends once access has begun, while our 14-day money-back guarantee applies regardless.
Do I need Excel or other software?
No. The labs run in a spreadsheet inside your browser on a laptop, tablet or phone. Function names and syntax follow Excel.
Is the certificate an official qualification?
No. It confirms that you completed all lessons of the course and passed its final exam. It is not an official, state-recognised or professional qualification. The name is taken from your profile when the certificate is issued.
Full details are in our Terms · hello@tutorvo.com
