Vietnam: How to handle adverse events during clinical testing?

10:05, 02/01/2016

This content is specified in Circular No. 55/2015/TT-BYT of the Ministry of Health of Vietnam regulating the recognition of clinical research and testing of new techniques and new methods in medical examination and treatment.

According to Circular No. 55/2015/TT-BYT of the Ministry of Health of Vietnam, if an adverse event occurs during a clinical testing, the following actions will be taken:

- The principal researcher of the organization conducting the clinical testing is responsible for monitoring, detecting, and managing adverse events that occur in the research subjects at their research facility.

- In cases where an adverse event poses a serious threat to the life of the participants in the clinical testing of new techniques and new methods, the principal researcher and the organization conducting the clinical testing must immediately stop the testing on the affected participant, provide the best available care and treatment at their research facility, and urgently report to the Ethics Committee, the Ethics Evaluation Board, the Department of Science, Technology, and Training - Ministry of Health.

- Based on the advisory opinion of the Ethics Evaluation Board, the Ministry of Health will consider and decide whether to continue the research, temporarily suspend the research, or terminate the research to ensure the safety of the research subjects.

View detailed provisions on handling adverse events during clinical testing at Circular No. 55/2015/TT-BYT of the Ministry of Health of Vietnam, effective from February 16, 2016.

- Khanh Chi -

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