Recommendations for reporting adverse drug reactions and adverse events of traditional Chinese medicine.

Clearly report adverse effect or adverse event occurred in the clinical practice is very important for understanding the potential risk of using a drug for treatment of diseases, and with other advantages. This document aims to help healthcare providers to organize, report, and publish information on ADR/AE occurrences and to identify the nature of the ADR/AE in TCM and integrative medicine practice. This document provides recommendations on constructing a title, basic factors of writing an abstract and the text of ADR/AE reporting. In each part, there are some samples could be references for the development of a report and ADR/AE. We welcome any comments for improving this recommendation.