GCP合规性调查核对表(医疗机构)

Quality Assurance Journal Pub Date : 2005-06-01 DOI:10.1002/QAJ.333

Kiyomi Hirayama, Naohisa Fukuda, H. Satoh, Katsumi Itoh, Kiyoshi Chiba, Yutaka Nakae, Masayuki Takezawa, K. Gotoh

{"title":"GCP合规性调查核对表(医疗机构)","authors":"Kiyomi Hirayama, Naohisa Fukuda, H. Satoh, Katsumi Itoh, Kiyoshi Chiba, Yutaka Nakae, Masayuki Takezawa, K. Gotoh","doi":"10.1002/QAJ.333","DOIUrl":null,"url":null,"abstract":"This checklist is an English translation of the Good Clinical Practice (GCP) compliance checklist prepared by the Japanese agency for on-site inspections of medical institutions. Please note that the checklist was translated by the authors and has not received official review by any Japanese agency including the Organization for Pharmaceutical Safety and Research (OPSR). \n \nThis checklist is an addendum to a previously published article on the evaluation of overseas GCP inspections by the Japanese Regulatory Agency [1]. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"29 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2005-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Checklist for GCP compliance investigation (Medical institution)\",\"authors\":\"Kiyomi Hirayama, Naohisa Fukuda, H. Satoh, Katsumi Itoh, Kiyoshi Chiba, Yutaka Nakae, Masayuki Takezawa, K. Gotoh\",\"doi\":\"10.1002/QAJ.333\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"This checklist is an English translation of the Good Clinical Practice (GCP) compliance checklist prepared by the Japanese agency for on-site inspections of medical institutions. Please note that the checklist was translated by the authors and has not received official review by any Japanese agency including the Organization for Pharmaceutical Safety and Research (OPSR). \\n \\nThis checklist is an addendum to a previously published article on the evaluation of overseas GCP inspections by the Japanese Regulatory Agency [1]. Copyright © 2005 John Wiley & Sons, Ltd.\",\"PeriodicalId\":147931,\"journal\":{\"name\":\"Quality Assurance Journal\",\"volume\":\"29 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2005-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Quality Assurance Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/QAJ.333\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Quality Assurance Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/QAJ.333","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 1

摘要

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Checklist for GCP compliance investigation (Medical institution)

This checklist is an English translation of the Good Clinical Practice (GCP) compliance checklist prepared by the Japanese agency for on-site inspections of medical institutions. Please note that the checklist was translated by the authors and has not received official review by any Japanese agency including the Organization for Pharmaceutical Safety and Research (OPSR). This checklist is an addendum to a previously published article on the evaluation of overseas GCP inspections by the Japanese Regulatory Agency [1]. Copyright © 2005 John Wiley & Sons, Ltd.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Quality Assurance Journal

自引率

0.00%

发文量