WorksheetsG-SOP learining SERIOUS BREACH
Total questions: 6
Worksheet time: 6mins
篡改(falsification)的定义？
明知故犯地创建、改变、记录或遗漏信息，从而使数据不代表实际发生的情况
盗用他人的想法、过程、结果或文字，而不给予适当的荣誉
编造数据或结果，并记录或报告它们
指操纵研究材料、设备或过程，或改变、遗漏数据或结果，使研究在研究记录中没有得到准确反映
Clinical Team Representative 在过程中需要完成的任务？
进行调查并记录结果
审阅批准提交给authority的报告
组织SBAT会议并记录会议结果
准备给authority的报告
Additional information is reviewed by Global R&D QA and it provides reasonable grounds to believe that a Serious Breach has occurred. In this case, when is “Day 0”？
When KKG staff became aware of this issue
When CRO/Vendor became aware of this issue
When Global R&D QA representative reviews the information
After 7 calendar days of the initial notification
SBAT Meeting may be set up by Global R&D representative on a non-business day to meet the reporting timeline.
True
False
What's the time requirement for reporting potential Serious Breach, misconduct, fraud or persistent non-compliance?
1-3 working day
within 5 working days
within 1 working day
Who is responsible for documenting the outcome of the meeting on the SBAT form?
Global R&D Head
clinical trial team representative
Global QA representative
Global RA representative
