Dossier for Registration of Clinical Trial Research Support Activities

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.

- ...

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.

Thu Ba

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