Literature Case to ICSR

Process a case from a published paper and submit as ICSR.

Role: PV Officer

Context: Weekly literature search finds a case report: patient on your drug developed hepatic failure. Author and institution are stated.

Task: Extract and report per GVP.

Step 1 of 2

Validity

case

Paper gives: initial and age, drug, reaction, outcome, author and affiliation.

Valid case?