Implementing Clinical Research in Vietnam: A Dialogue on the Current Regulations of the Ministry of Health

FHI has recently published the proceedings of a two-day meeting held in Hanoi in July 2007, in which representatives from three departments at the Ministry of Health presented government regulations and procedures for conducting clinical research in Vietnam. The title of the publication is "Implementing Clinical Research in Vietnam: A Dialogue on the Current Regulations of the Ministry of Health".
Since internationally sponsored clinical trials are relatively new in Vietnam and the appropriate processes have not always been clear to investigators and medical centers, the purpose of the workshop was to clarify these procedures and open a dialogue between the Ministry of Health and clinical research sites.
Topics presented and discussed at the workshop included overview of International Guidelines for clinical research; the important role of ethics oversight including the close monitoring of patient safety; guidance for study sites regarding the processes to seek MOH approval for new study protocols; and the processes of importing drugs and
supplies needed to conduct the study.
We at FHI see this meeting as an important step in the ongoing development of the practice of clinical research in Vietnam. We would like to acknowledge the Ministry of Health representatives who presented the material and were open to questions and comments from investigators from research sites throughout the country. We are also grateful to the clinical study site staff that were present and shared their experience in conducting clinical research trials in Vietnam so far.
If you would like to receive a copy of this publication please email Peggy Coyle, Clinical Research Manager, FHI Vietnam at [email protected]

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