How to report ADRs?

There are different Case Report Forms in different countries. But all of them have at least four sections which should be completed :


1. Patient information:patient identifier, age at time of event or date of birth, gender , weight

2. Adverse event or product problem: description of event or problem, date of event, date of this report , relevant tests/laboratory data (if available) other relevant patient information/history, outcomes attributed to adverse event

3. Suspected medication(s):name (INN and brand name), dose, frequency & route used , therapy date, diagnosis for use, event abated after use stopped or dose reduced, batch number, expiration date, event reappeared after reintroduction of the treatment, concomitant medical products and therapy dates

4. Reporter:name, address and telephone number, speciality and occupation.