G-SOP learining SERIOUS BREACH

G-SOP learining SERIOUS BREACH

Professional Development

6 Qs

quiz-placeholder

Similar activities

认识我们的牙宝贝

认识我们的牙宝贝

Professional Development

10 Qs

K1 Science Quizz Game 16-11

K1 Science Quizz Game 16-11

Professional Development

10 Qs

Y3科学 3rdweek

Y3科学 3rdweek

Professional Development

10 Qs

Y5SN - Nov 1/2 (选择题复习)

Y5SN - Nov 1/2 (选择题复习)

Professional Development

10 Qs

112-2 五下 CH4 溫度改變對物質的體積有何影響

112-2 五下 CH4 溫度改變對物質的體積有何影響

Professional Development

3 Qs

e-teacher

e-teacher

Professional Development

4 Qs

Squad Health Check Model

Squad Health Check Model

Professional Development

11 Qs

資訊安全- 社交工程測驗

資訊安全- 社交工程測驗

Professional Development

8 Qs

G-SOP learining SERIOUS BREACH

G-SOP learining SERIOUS BREACH

Assessment

Quiz

Science

Professional Development

Hard

Created by

sizhe chen

Used 3+ times

FREE Resource

6 questions

Show all answers

1.

MULTIPLE CHOICE QUESTION

1 min • 5 pts

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

2.

MULTIPLE SELECT QUESTION

1 min • 5 pts

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

3.

MULTIPLE CHOICE QUESTION

1 min • 5 pts

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

4.

MULTIPLE CHOICE QUESTION

45 sec • 5 pts

SBAT Meeting may be set up by Global R&D representative on a non-business day to meet the reporting timeline.

True

False

5.

MULTIPLE CHOICE QUESTION

1 min • 5 pts

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

6.

MULTIPLE CHOICE QUESTION

1 min • 5 pts

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