ICSR assessment
Review a synthetic individual case safety report and write the case narrative.
What you'll practice
- Read a synthetic case and separate reported events from medical history
- Draft a narrative a drug-safety reviewer can follow
- Note seriousness, listedness clues, and what is still missing
- Record the questions you would send back to the source
Sample input
Preview: a 54-year-old patient starts a synthetic medicine, then reports fatigue and a rash. The public preview stops before the lab table, concomitant products, and reporter comments.
What you'll submit
A case narrative in the challenge template, plus a short list of follow-up questions.
Scoring rubric
Completeness · 30 points
The narrative covers the events, dates, and products present in the source.
Coding consistency · 25 points
Terms used in the narrative match the events you would code.
Seriousness · 25 points
Seriousness is stated and tied to the information given, without inventing outcomes.
Clarity · 20 points
A second reviewer can see what is known and what is missing.
What you receive
A score from 0 to 100, written feedback from a reviewer, and a portfolio record you can share after review.
FAQ
Is the case real?
No. The source is synthetic and written for practice.
Do I need MedDRA access?
No. Name the events in plain language. The coding challenge is separate.
What does the reviewer return?
A score from 0 to 100 and written comments. This is not a certificate.
