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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: IEC and IRBs

Question Number 1:

According to ICH GCP it is recommended that the IRB/IEC should include at least five members. However, as this is a recommendation ICH GCP also references the number of members in the following statement.

"The IRB/IEC should consist of XXXXX"
A
 at least two members
B
 at least three members
C
 the number of members stated in its procedures
D
 a reasonable number of members

Question Number 2:

What does ICH GCP state that the members of an ethics committee should collectively have the qualifications and experience to review and evaluate of the proposed trial?

  1. medical aspects
  2. science
  3. statistical aspects
  4. ethics
A
 1 and 4 only
B
 2, 3 and 4 only
C
 1, 2 and 4 only
D
 All of them

Question Number 3:
Which of the Code of Federal Regulations in the USA covers the subject of IRB Membership
A
 21 CFR 11.101
B
 21 CFR 56.107
C
 21 CFR 61.211
D
 21 CFR 11.221

Question Number 4:
The US CFR states that an IRB shall have how many members?
A
 at least five members
B
 at least 8 members
C
 a resonable number of members
D
 at least 10 members

Question Number 5:
The US CFR states that an IRB shall be sufficiently qualified through the experience and expertise of its members and what else?
A
 qualifications of members
B
 inclusion of specific expertise when necessary
C
 diversity of members
D
 ongoing assessment of members

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