gcp.nidatraining.org/mo 11. 可能影响研究参与的新信息:参与者是否愿意继续参加试验有关的信息,将及时通知参与者 12. 研究联系人:研究和参与者权利的问题应该联系谁(包括首席研究员的姓名和电话号码),有关试验和试验参与者在试验相关伤害情况下的权利的进一步信息需要联系的人员。 13. 参与时间和参与研究的人数:...
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. IRB表示赞成的决定:指对一项临床试验已经...
试验数据(trial data)-准确(accurate)、完整(complete),能从源文件(source documents)得到核实(verify) 试验实施(conduct of the trial)-符合最近批准的方案/方案修改(compliance with the currently approved protocol/amendments)、符合GCP、符合适用管理要求(applicable regulatory requirements) 笔记:每次到中心必须做的...
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. IRB表示赞成的决定:指对一项临床试验已经...
按照GCP、适用管理要求(见4.1.3)和经申办者同意、IRB/IEC批准/赞成(见4.5.1)和方按实施临床试验。 b)to comply with procedures for data recording/reporting;遵循数据记录/报告程序 c) to permit monitoring, auditing and inspection (see 4.1.4) and运行监查、稽查及...
为保证试验的进行和数据产生、记录以及报告都符合临床试验管理规范(GCP)和适用管理要求所建立的有计划的系统活动。 1.47 Quality Control (QC) 1.47质量控制(QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-rela...
Why is GCP training necessary? This training is important for all staff involved in Clinical Research and ensures an understanding of the principles adopted in research. 这项培训对参与临床研究的所有工作人员非常重要,并确保了解研究中通过的原则。
This free ICH GCP training course is designed to demonstrate the quality of Biopharma Institute's training and learning management system.
TheobjectiveofthisICHGCPGuidelineistoprovideaunifiedstandardfortheEuropeanUnion(EU),JapanandtheUnitedStatestofacilitatethemutualacceptanceofclinicaldatabytheregulatoryauthoritiesinthesejurisdictions. ICH-GCP指导原则的目的是为欧盟、日本和美国提供统一的标准,以促进这些管理当局在其权限内相互接受临床数据。 Theguideline...
the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). 本指导原那么的进展考虑了欧盟、日本、美国,以及澳大利亚、加拿大、北欧国家和世界卫生组织〔WHO〕的现行GCP。