Akiyama Teppei, Furuta Mitsuko, Yamada Hiroshi
The Office of Conformity Audit, Pharmaceuticals and Medical Devices Agency.
Nihon Kokyuki Gakkai Zasshi. 2006 Aug;44(8):541-9.
The guidelines for Good Clinical Practice (GCP) in Japan have been harmonized with ICH-GCP. Both the protection of human rights and the carrying out of clinical trials ethically and scientifically, conforming to the GCP, are necessary for the safety and efficacy of clinical data of common technical documents. It is standard practice in Japan, the U.S., and the E.U. to ensure conformity with all data from raw data to application materials. In April, 2004, the new independent organization Pharmaceuticals and Medical Devices Agency (PMDA) was established in Japan. The PMDA provides services focusing on the three key areas of Review, Safety, and Relief. The Office of Conformity Audit is one of the offices in the Center for Product Evaluation of the PMDA. In the conformity audit service of the Office of Conformity Audit of the PMDA, the reliability and conformity with the GCP between case report forms (CRFs) as basis materials and application materials is confirmed by the document-based conformity review, and the conformity between medical records as raw data and CRFs is assessed through the on-site GCP review. Therefore, such application materials are considered to be consistent with international standards. The important issues raised by the GCP on-site review by the Office of Conformity Audit of the PMDA are summarized in this study. We hope that our findings at investigational sites will promote the protection of human rights and improve the quality of clinical trials in Japan.
日本的《药物临床试验质量管理规范》（GCP）指南已与国际协调会议（ICH）的GCP协调一致。为确保通用技术文档临床数据的安全性和有效性，保护人权以及按照GCP伦理且科学地开展临床试验均很有必要。在日本、美国和欧盟，确保从原始数据到申报材料的所有数据均符合规范是标准做法。2004年4月，日本成立了新的独立机构药品和医疗器械局（PMDA）。PMDA提供聚焦于审评、安全和救济这三个关键领域的服务。合规审计办公室是PMDA产品评估中心的办公室之一。在PMDA合规审计办公室的合规审计服务中，作为基础材料的病例报告表（CRF）与申报材料之间的可靠性及与GCP的符合性通过基于文件的合规审查来确认，而作为原始数据的病历与CRF之间的符合性则通过现场GCP审查进行评估。因此，此类申报材料被认为符合国际标准。本研究总结了PMDA合规审计办公室进行GCP现场审查时提出的重要问题。我们希望我们在研究现场的发现将促进日本的人权保护并提高临床试验质量。
