GCP（Good Clinical Practice）全称是药物临床试验质量管理规范，首先要了解GCP常见的2个版本的区别：中文版为GCP China 2003，由CFDA（国家食品药品监督管理总局）于2003年颁布（后来的修订版本都是以这一版为基础）；英文版为2016年颁布的ICH-GCP（E6 R2），由1996年颁布的ICH GCP Guidelines发展而来。ICH的含义 IC...
ICH/GCP guidelines: self-evaluation questionnairedoi:10.1002/(SICI)1099-1786(199706)2:2<74::AID-QAJ31>3.0.CO;2-PPDPostfachPharmacoPostfachWileyQuality Assurance Journal
2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. 2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience...
Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: De...
1996年6月10日发布的ICH GCP(R1)指南于1997年在《美国联邦公报》上公布,并于2016年11月9日修订为R2版。这些指南适用于所有涉及人类研究参与者的研究。 The purpose of the ICH GCP guidelines is twofold:· To ensure that the rights, safety, and confidentiality of participants in clinical trials are ...
In April 2020 to engage stakeholders for the revision of ICH E6(R3) with a view to ensuring that the guidelines are responsive to the needs of those conducting or participating in clinical trials, and a summary of the E6(R3) Stakeholder Engagement Approac...
Nordic countries and the World Health Organization (WHO). ICH GCP的参考文件是什么呢? 由于ICH GCP是为ICH成员国提供数据互认统一标准,因此在设定的时候参考了包括欧盟、美国、澳大利亚、北欧国家以及WHO的GCP。 This guideline should be followed when generating clinical trial data that are intended to be ...
In April 2020 to engage stakeholders for the revision of ICH E6(R3) with a view to ensuring that the guidelines are responsive to the needs of those conducting or participating in clinical trials, and a summary of the E6(R3) Stakeholder Engagement Approach was made available. ...
In April 2020 to engage stakeholders for the revision of ICH E6(R3) with a view to ensuring that the guidelines are responsive to the needs of those conducting or participating in clinical trials, and a summary of the E6(R3) Stakeholder Engagement Approach was made available. ...
conjunction with other ICH guidelines relevant to the conduct of clinical trials (e.g., E2A (clinical safety data management), E3 (clinical study reporting), E7 (geriatric populations), E8 (general considerations for clinical trials), E9 (statistical principles), and E11 (pediatric populations)...