Abstract: Case report is an important model of clinical study reports, taking obvious advantages on unusual or serious adverse drug reaction reports. This paper introduces case report from the concept, classification and criterion of case reporting. Based on methodological characteristics of adverse drug reaction case reports and reference of the standard of international case reports, we also develop and propose suggested items of case reports as a reference for clinical workers and researchers in medical field.

Key words: case report, evidence-based, adverse drug reaction, reporting criterion