INTERMEDIATEPharmacovigilance90 min

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.