Chương VII Thông tư 03/2012/TT-BYT: Giám sát, kiểm tra đảm bảo chất lượng nghiên cứu

Chapter VII

SUPERVISION AND INSPECTION OF RESEARCH QUALITY ASSURANCE

Article 34. Supervision, inspection of clinical drug trial process

1. Supervision and inspection to ensure the rights and interests and health of participants in clinical drug trial; ensure the recorded data of the research to be conducted fully and accurately, timely and in accordance with regulations of the research outline approved.

2. Ministry of Health establishes the delegation of monitoring, period, and irregular inspection for each specific case.

3. Competent state management agencies, organizations and individuals with drugs of clinical trial, clinical research organization (CRO) or research site management organization (SMO) approved by the Health Ministry in writing may propose the appointment of persons for systematic monitoring and supervision of the research process. The person who is assigned the task of supervision is not a member of the research team, complies with regulations on security of research data and other information related to clinical trial participants and take responsibility before the management agencies for their works.

4. Major researchers and the researchers are responsible for creating conditions for the supervisor to refer the research data upon request.

5. Delegation of supervision, inspection is responsible for checking the report, proposing by the minutes of supervision and inspection of the supervision contents with competent state management agencies as the basis for the consideration and handling according to the provisions of law.

Article 35. Assurance of the reliability of research results of clinical drug trial

1. To ensure research with sufficient reliability, the analysis and judgment, conclusions on the results must be derived from the original data. In each research stage, it should examine all the clinical data and testing criteria.

2. In necessary cases, the acceptance councils at all levels will invite experts for evaluating results, checking data, testing products of research or establish the board of monitoring data (DSMB) at the request of the management agency.