A Prospective Study on the Establishment of International Standards for GRP-ICM and GQP-ICM

• Published in: Journal of traditional Chinese medicine Vol. 31; no. 1; pp. 64 - 68
• Main Author: 荣培晶 李宗友
• Format: Journal Article
• Language: English
• Published: China 01.03.2011
• Subjects: Biomedical Research - organization & administration; Biomedical Research - standards; China; GRP; Humans; ICM; Medicine, Chinese Traditional - standards; Prospective Studies; Surveys and Questionnaires; 专家咨询; 国际标准; 标准制定; 研究机构; 科研机构; 质量管理标准; China
• ISSN: 0255-2922
• DOI: 10.1016/S0254-6272(11)60015-0

Objective： In order to promote the construction of scientific research institutions of TCM in the world and to raise the vitality of the institutions, a prospective study has been done on the establishment of the international standards for the research institutions and quality management, namely, Good Research Practice - Institution of Chinese Medicine （GRP-ICM） and Good Quality Practice - Institution of Chinese Medicine （GQP-ICM）. Methods： The document analysis, questionnaire, and experts＇ consultation were adopted to solicit the opinions on the establishment ofinternational standards for the research institutions and quality management. A total of 74 experts from 22 countries and regions （including China） participated in the questionnaire survey, and 30 experts from 11 countries and regions received the consultations and interviews. Results： In the survey, 85.14% of the experts （63/74 experts）considered that it is necessary to establish the unified international standards; 90.00% appraised GRP-ICM excellent and 80.00% appraised GQP-ICM goods; and 93.10% thought that these two standards can be implemented or can be implemented after revision. Conclusion： This is a prospective study on the establishment ofinternational standards for the research institutions and quality management, with a preliminary understanding of the basic framework, main contents and formulating principles. It lays a solid foundation for the establishment and implementation of the unified international standards for the research institutions and quality management.