CAJ | 학술논문

医务人员是临床试验的主要设计者和参与者,普及《药物临床试验质量管理规范》(GCP)有助于提高医务人员临床试验的水平规范临床试验的管理,保护受试者的合法权益及健康安全,提高临床试验结果可靠性,从而提升我国医疗机构进行临床试验的能力,促进医药相关产业的发展.从建立临床试验职业资格准入制度和监督管理机制、将《药物临床试验管理规范》(GCP)培训纳入继续教育体系2个方面进行了探讨,提出了加强医务人员GCP培训的途径和建议.
의무인원시림상시험적주요설계자화삼여자,보급《약물림상시험질량관리규범》(GCP)유조우제고의무인원림상시험적수평규범림상시험적관리,보호수시자적합법권익급건강안전,제고림상시험결과가고성,종이제승아국의료궤구진행림상시험적능력,촉진의약상관산업적발전.종건립림상시험직업자격준입제도화감독관리궤제、장《약물림상시험관리규범》(GCP)배훈납입계속교육체계2개방면진행료탐토,제출료가강의무인원GCP배훈적도경화건의.
Medical workers are the main designers and participants of clinical trials.In this consideration,popularization of good clinical practice (GCP)knowledge among them can improve their execution of trials,standardize basic clinical trial requirements,protect legitimate rights and health/safety of the subjects,and make the trial results more reliable.These objectives,if accomplished,will upgrade the clinical trials competency of medical institutions in China,and encourage healthy growth of the medical and pharmaceutical industry.The paper probed into the occupation qualification system of clinical trial workers and their supervision mechanism,inclusion of GCP into the continuing education system.