THE MINISTRY OF HEALTH

Circular No. 08/2014/TT-BYT dated February 26, 2014 of the Ministry of Health February 26, 2014 providing for the support activities of clinical trial research in Vietnam        
Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012, defining functions, tasks, powers and organizational structure of the Ministry of Health;
The Minister of Health promulgates Circular providing for activities supporting clinical trial research in Vietnam.
Chapter 1.
GENERAL PROVISIONS
Article 1. Scope of regulation, subjects of application
This Circular promulgates conditions, registration, scope of activities, rights and duties of organizations operating in support for clinical trial research in Vietnam (below collectively referred to as the research supporting organizations).
Article 2. Interpretation of terms
1.Support activities for clinical trial research include supervision, inspection, statistical analysis and data management, conduct tests and provide administrative supports in clinical trial research.
2.Clinical Research Associate – CRA means a person who have professional qualifications and experiences which are consistent with field of supporting clinical trials which are required to conduct supervision, understand well research profiles and regulation of the International Conference on Harmonization of registration dossier of pharmaceuticals – guideline for Goods Clinical Practice (ICH GCP) and other relevant legal provisions.
3.Clinical Research Coordinator - CRC means a person working for an organization supporting clinical trial research, having task to support the main researcher during the process of the clinical trial research; managing documents, files and databases relating to the research; supporting for the organization receiving clinical drug trial upon working with donors, supervisors and inspectors.
Chapter 2.
CONDITIONS FOR SUPPORT ACTIVITIES FOR CLINICAL TRIAL RESEARCH IN VIETNAM
Article 3. General conditions of support organizations for clinical trial research
1. Organizational conditions:
Being organizations which have legal person status, operate in the field of clinical trial research, established according to decisions of competent state agencies for state-run organizations or certificates of business registration or operation licenses issued by competent state agencies in Vietnam for private organizations and non-governmental organizations.
2. Conditions on human force:
a) Persons who are in charge of profession must have college degrees or higher of health science sector in line with scope of professional activities of organizations supporting clinical trial research, and have 03 years of experience or more in at least one sector pertaining to support activities for clinical trial research.
b) Have sufficient staff satisfying conditions as prescribed in this Circular and consistent with scope of professional activities as registered of the research supporting organizations.