04 Conditions for Organizations Supporting Clinical Trial Research

According to current regulations, activities supporting clinical trial research include supervision, inspection, statistical analysis and data management, testing, and administrative support in clinical trial research.

To be specific, general conditions for organizations supporting clinical trial research are specified in Circular 08/2014/TT-BYT as follows:

Organizational Conditions:

- Must be a legal entity operating in the field of clinical trial research, established by decision of a competent state agency for state organizations or with a business registration certificate or an operating license issued by the competent state agency in Vietnam for private organizations or non-governmental organizations.

Human Resource Conditions:

- The head of the professional division must have a college degree or higher in health sciences relevant to the organization's scope of activities supporting clinical trial research, and at least 3 years of experience in at least one area related to clinical trial research support activities.- Must have sufficient staff meeting the conditions specified in this Circular according to the organization's registered scope of professional activities in supporting research.

Infrastructure Conditions:

- Must have an office, infrastructure, and equipment ensuring the implementation of activities supporting clinical trial research suitable to the registered scope of professional activities following Form No. 01 issued with this Circular.

Quality Assurance Conditions:

- Must have Standard Operating Procedures (SOP) for registered clinical trial activities.- Must have a document storage system capable of providing evidence that activities are conducted according to SOP.- Must have a quality assurance system meeting ISO standards or equivalent standards.

In addition to the above conditions, organizations that register to support one or more activities in clinical trial research such as research supervision, research inspection, statistical analysis and data management, research testing, administrative research support must meet the corresponding conditions specified in Articles 4, 5, 6, 7, 8 of Circular 08/2014/TT-BYT.

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

Thu Ba

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