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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: What Does GCP Say?

Question Number 1:

Which of the following is true about the following statement:

"Investigators and other relevant staff should generally be blind to the block length"

A
It is contained in section 4 of ICH GCP
B
It is contained in section 5 of ICH GCP
C
It is contained in ICH E9
D
It does not appear in the ICH Guidelines

Question Number 2:

Which of the following is true about the statement below:

"It is recommended that the investigator inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed."

A
It is contained in section 4 of ICH GCP
B
It is not referred to in ICH GCP
C
It is contained in section 2 of ICH GCP
D
It is contained in ICH E1

Question Number 3:

Which of the following is true about the statement below:

"Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence"

A
It is contained in section 5 of ICH GCP
B
It is contained in section 4 of ICH GCP
C
It is contained in the Declaration of Helsinki
D
None of the above

Question Number 4:

Which of the following is true about the following statement:

"When trial subjects receive compensation, the method and manner of compensation should comply with applicable regulatory requirement(s)."

A
It is contained in the Declaration of Helsinki
B
It is contained in section 5 of ICH GCP
C
It is contained in ICH E2
D
None of the above

Question Number 5:

Which of the following is true about the statement below:

"Clinical trials should be conducted in accordance with the ethical  principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)."

A
It is contained in section 2 of ICH GCP
B
It is contained in section 3 of ICH GCP
C
It is contained in the Declaration of Helsinki
D
None of the above

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