The content is specifically stipulated in Circular 08/2014/TT-BYT, which regulates the activities supporting clinical trials research in Vietnam.
Circular 08/2014/TT-BYT stipulates the organization of registration activities to support clinical trial research, submitting the registration dossier including:
- Application for registration of activities supporting clinical trial research in Vietnam.- A certified copy of one of the following documents: Establishment Decision, Operation License, Investment License, or Business Registration Certificate of the organization.- Personnel declaration.- Requirements for the dossier for clinical trial research monitoring activities:
- Certified copy of university degree or higher in a field relevant to the research support activities.- Certified copy of a certificate or training certificate in clinical research monitoring and good clinical practices issued by the Ministry of Health or an organization recognized by the Ministry of Health.- Certified copy of a certificate or proof of being trained in the theory and practice of annual periodic monitoring on clinical trial research.
- Requirements for the dossier for clinical trial research inspection activities:
- Certified copy of university degree or higher in a field related to the field of clinical trial research inspection.- Certified copy of a certificate or training certificate in initial theory, practical inspection, and periodic training on clinical trial research.
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Note: Organizations that have conducted clinical research support activities before the effective date of this Circular must complete the procedures for registration as stipulated by Circular 08/2014/TT-BYT before November 1, 2014.
See detailed regulations at Circular 08/2014/TT-BYT effective from May 1, 2014.
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