Local Case Report Forms (CRF) should be obtained from the National Drug Regulatory Authority. Some countries have included CRF in their National Formularies (British National Formulary, Formularies of South Africa, Zimbabwe etc.).

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

The completed Case Report Form should be sent to the national or regional ADR centre or to the manufacturer of the suspected product.

Addresses of National Drug Regulatory Authorities and other useful information can be found on the Website of the WHO Collaborating Centre for International Drug Monitoring (www.who-umc.org) or requested from this Centre by e-mail: info@who-umc.org; by Fax: +46 18 65 60 80 or by Tel.: +46 18 65 60 60.