G-SOP learining SERIOUS BREACH

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