[德国伦理审查委员会多中心学术研究申请]。

IF 0.3 4区 医学 Q4 Medicine Onkologie Pub Date : 2013-01-01 DOI:10.1159/000348270
Nicola Gökbuget, Ralph Naumann
{"title":"[德国伦理审查委员会多中心学术研究申请]。","authors":"Nicola Gökbuget,&nbsp;Ralph Naumann","doi":"10.1159/000348270","DOIUrl":null,"url":null,"abstract":"<p><p>Before the start of a clinical trial, approval by the responsible institutional ethical review board (IRB) is required. In Germany, nearly 50 independent IRBs may be responsible for the different participating sites of a multicenter study. In trials for rare diseases, the participation of many centers is required. Therefore, the application procedure for academic multicenter trials in malignant hematologic diseases is often a bureaucratic nightmare. Different aspects of IRB application and possible approaches for improvement are presented.</p>","PeriodicalId":19684,"journal":{"name":"Onkologie","volume":"36 Suppl 2 ","pages":"29-35"},"PeriodicalIF":0.3000,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000348270","citationCount":"6","resultStr":"{\"title\":\"[Application for academic multicenter studies at German ethical review boards].\",\"authors\":\"Nicola Gökbuget,&nbsp;Ralph Naumann\",\"doi\":\"10.1159/000348270\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Before the start of a clinical trial, approval by the responsible institutional ethical review board (IRB) is required. In Germany, nearly 50 independent IRBs may be responsible for the different participating sites of a multicenter study. In trials for rare diseases, the participation of many centers is required. Therefore, the application procedure for academic multicenter trials in malignant hematologic diseases is often a bureaucratic nightmare. Different aspects of IRB application and possible approaches for improvement are presented.</p>\",\"PeriodicalId\":19684,\"journal\":{\"name\":\"Onkologie\",\"volume\":\"36 Suppl 2 \",\"pages\":\"29-35\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2013-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1159/000348270\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Onkologie\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1159/000348270\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Onkologie","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1159/000348270","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 6

摘要

在开始临床试验之前,需要得到负责的机构伦理审查委员会(IRB)的批准。在德国,近50个独立的irb可能负责多中心研究的不同参与站点。在罕见疾病的试验中,需要许多中心的参与。因此,恶性血液病的学术多中心试验的申请程序往往是官僚主义的噩梦。介绍了IRB应用的不同方面和可能的改进方法。
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
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
[Application for academic multicenter studies at German ethical review boards].

Before the start of a clinical trial, approval by the responsible institutional ethical review board (IRB) is required. In Germany, nearly 50 independent IRBs may be responsible for the different participating sites of a multicenter study. In trials for rare diseases, the participation of many centers is required. Therefore, the application procedure for academic multicenter trials in malignant hematologic diseases is often a bureaucratic nightmare. Different aspects of IRB application and possible approaches for improvement are presented.

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
Onkologie
Onkologie 医学-肿瘤学
CiteScore
0.40
自引率
33.30%
发文量
0
审稿时长
3 months
期刊最新文献
Adjuvant treatment for colorectal cancer Trends in the treatment of metastatic castration-sensitive prostate cancer Management of adverse reactions during treatment of anal cancer Tinnitus - an initial symptom of synchronous occurence of paraganglioma and renal cell carcinoma in a germline mutation of the SDHB gene (PGL4 snydrome) Hepatoblastoma in three siblings associated with familial adenomatous polyposis
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1