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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: ICH GCP IRB and IEC

Question Number 1:
The IRB/IEC should review payments to subjects and ensure that payments are prorated and not wholly contingent on what?
A
 the risk associated with the trial
B
 completion of the trial by the subject
C
 the expected risk benefit profile for the outcome
D
 the phase of development

Question Number 2:
What is missing from the following statement: The IRB/IEC should review both the XXXXXXX of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects.
A
 frequency and amount
B
 amount and phasing
C
 amount and method
D
 amount and documentation

Question Number 3:

The IRB/IEC should ensure that information regarding payment to subjects, including XXXXXXX, is set forth in the written informed consent form and any other written information to be provided to subjects. Which of the following are missing from the statement?

  1. methods
  2. amounts
  3. schedule of payments
  4. required documentation of expenditure
A
 1 and 2 only
B
 2, 3 and 4 only
C
 1, 2 and 3 only
D
 2 and 4 only

Question Number 4:
According to ICH GCP the IRB/IEC should conduct continuing review of each ongoing trial how often?.
A
 at least once a year
B
 at intervals appropriate to the degree of risk to human subjects, but at least once per year
C
 at intervals appropriate to the degree of risk to human subjects, but at least once during the accrual period of the trial
D
 there is no guidance provided

Question Number 5:

What is missing from the following statement in ICH GCP: The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the XXXXX of the proposed trial.

  1. Ethics
  2. Science
  3. Design
  4. Medical Aspects
A
 3 and 4 only
B
 1 and 3 only
C
 1, 3 and 4 only
D
 1, 2 and 4 only

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