Conditions on the Application Dossier for Support in Clinical Trial Research

20:49, 10/07/2024

On February 26, 2014, the Ministry of Health has issued Circular 08/2014/TT-BYT regulating activities that support clinical trial research in Vietnam.

According to the regulations in Circular 08/2014/TT-BYT, the general conditions regarding the language, format, and legality of the registration dossier for clinical trial research support activities must be met:

ho tro nghien cuu thu nghiem lam sang, ho so, dieu kien

Language expressed in the dossier:

- The language in the registration dossier of the organizations supporting research must be in Vietnamese. Foreign language professional documents must be translated into Vietnamese.

Format of the dossier:

- The registration dossier for clinical trial research support activities in Vietnam must be prepared on A4 paper size, securely bound, with a table of contents, documents arranged in the correct order of the table of contents, with separators and guides between sections, and the separators must be numbered for easy reference.

Legality of the dossier:

- The registration application and the contents of the registration dossier must be signed and sealed according to the regulations by the legal representative or the lawfully authorized person of the registering organization. Legal documents originating from foreign countries must be authenticated by the competent authority and consular legalized as per regulations.

See detailed regulatory content in Circular 08/2014/TT-BYT, effective from May 1, 2014.

Thu Ba

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