The Outcome Classification Commission is responsible for classifying malformations recorded descriptively in the Case Report Forms. Once a month, the Central Registry forwards all reports of congenital abnormalities to the commission. Assessment, which is based on the ICD 9 and Eurocat systems, is carried out blindly as far as exposure to antiepileptic medication and other risk factors are concerned. Minor anomalies are not included, as the teratogenic endpoint of the protocol is major malformations.
Reporting physicians are encouraged to report anything they consider to be abnormal providing all the necessary specifications. When necessary, the OCC asks for additional information.