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.