Practice of PDCA Method in the New Specialties Accreditation of Drug Clinical Trial Institution / 中国药房

OBJECTIVE:To explore the effects of PDCA method in the new specialties accreditation of drug clinical trial institution. METHODS:PDCA method was used for drug clinical trial institution office and 9 newly applied majors in our hospital. Total score of each major were compared before and after intervention,in order to make the newly applied major meet the standard of specialties accreditation of drug clinical trial. RESULTS:After conducting PDCA related training,establishing new specialties accreditation work group,formulating work goals and plans,9 new majors of our hospital were all approved by CFDA for new specialties accreditation;after intervention total score of each accreditation item for newly applied major were all higher than before intervention,with statistical significance(P<0.05),improved by more than 45.57%. CONCLUSIONS:It is feasible to adopt PDCA method in the preparation of new specialty accreditation of drug clinical trials. It is of significance to guarantee scientific and reliable drug clinical trial results and protect the rights and interests of the subjects.

Clinical test qualification revelation review the inspection of standardized management agency / 中华医学科研管理杂志

This article from the clinical trials of the drug inspection agency review practice of view,summarize the key elements of drug clinical trials review examination,the status of agency offices of the daily management and analysis of the problems,the agency's Office to review how the inspection standards as a guide to clinical trial program files,personnel and other standardized management were discussed,with a view of other drugs in clinical trials and routine inspection agency review management to bring new inspiration,clinical trials of drugs for hospitals and fast construction and development agencies to provide a reference.

Approaches to Improve the Core Competitive Power of Drug Clinical Trial Institutions / 中国药房

OBJECTIVE:To provide references for improving the quality of clinical trial of new drug (phase I-IV),guaranteeing participants' interests and enhancing the core competitive power of drug clinical trial institutions. METHODS: The advantages of both the guiding principle of Good Clinical Practice(GCP) and the quality standards of ISO/IEC17025:2005 were applied throughout the quality control process of clinical drug trial. RESULTS & CONCLUSIONS: To establish quality management and supervision system in China that is in line with the international norm and national condition by combining GCP principle with the quality standards of ISO/IEC17025 is conducive to the improvement of the quality of clinical drug trial and enhancement of the core competitive power of drug clinical trial institutions in China.