Abstract: Objective To evaluate the standardization of Case Report(CARE) on drug safety, improve the accuracy and transparency of case reports, and provide sufficient information for identification of adverse drug reactions and the causality between drugs and events. Methods Based on CARE Checklist and Chinese Journal of Pharmacovigilance, the quality of case reports published in this journal over the past ten years was assessed. Results Between 2010 and 2019, 508 case reports were published in Chinese Journal of Pharmacovigilance on drug safety. Each report had an average of 5.85 items that met the 14 items requirements of CARE Checklist. Follow-up and results were fully reported, adverse reactions and adverse drug events were described in detail; but the description of the patients' condition was based on results of detection currently available, and the limitations of cases were not fully reported. Conclusion We recommend reporting the past history of a patient in detail, presenting the diagnostic process, and mentioning the perspective and experience of patients, which can improve the accuracy and transparency of case reports and provide more information for identification of adverse drug reactions and the causality between drugs and events.

Key words: safety, case reports, CARE, standardization of case reports