- 1、本文档共18页,可阅读全部内容。
- 2、有哪些信誉好的足球投注网站(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
- 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载。
- 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
- 5、该文档为VIP文档,如果想要下载,成为VIP会员后,下载免费。
- 6、成为VIP后,下载本文档将扣除1次下载权益。下载后,不支持退款、换文档。如有疑问请联系我们。
- 7、成为VIP后,您将拥有八大权益,权益包括:VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
- 8、VIP文档为合作方或网友上传,每下载1次, 网站将根据用户上传文档的质量评分、类型等,对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档
查看更多
GoodClinicalPracticeGCP-KennesawStateUniversity
By: Kris Traver and Nitin Jain Goals and Objectives To understand: The affect of Good Clinical Practices on institutions conducting Clinical Research To discuss: What is GCP Guidelines for GCP The history of Good Clinical Practices Basic principles Practices and strategy for staying compliant with Good Clinical Practices. What Is GCP? Good Clinical Practice (GCP) is defined as a ‘standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected’ Good Clinical Practice Guidelines Are mainly focused on the protection of human rights in clinical trial. Provide assurance of the safety of the newly developed compounds. Provide standards on how clinical trials should be conducted. Define the roles and responsibilities of clinical sponsors, clinical research investigators, Clinical Research Associates, and monitors. Good Clinical Practice Guidelines (Continued) GCPs are generally accepted, international best practices for conducting clinical trials and device studies They are defined as an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects Compliance with GCPs provide public assurance that the rights and safety of participants in human subject research are protected and that the data that arises from the study is credible The Core of the Consolidated GCP Guidance 1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements 2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial
文档评论(0)