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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: Clinical Trials in India

Question Number 1:
Which of the following is the body responsible for Ethics Committees in India?
A
 Indian National Ethics Board
B
 Central Drugs Standard Control Organization
C
 Indian Council of Medical Research
D
 There is no such body

Question Number 2:
Which of the following is the body responsible for Regulatory Control of drugs in India?
A
 Indian National Ethics Board
B
 Central Drugs Standard Control Organization
C
 Indian Council of Medical Research
D
 Medicines Control Agency

Question Number 3:
According to the Indian Ethical Guidelines for Biomedical Research on Human Participants what is the generally accepted mimumum number of members an Ethics Committee should have?
A
 5
B
 6
C
 7
D
 8

Question Number 4:
According to Indian GCP how long should the sponsor retain study related documentation?
A
 3 years after completion of the study or submission to the regulatory authority.
B
 5 years after completion of the study or submission to the regulatory authority.
C
 15 years after completion of the study or submission to the regulatory authority.
D
 2 years after marketing authorisation

Question Number 5:
According to Indian GCP how frequently should the monitor visit the investigational site?
A
 There is no requirement for monitoring in India
B
 Every 4-6 weeks
C
 Before, during and after the study
D
 At least once

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