Question 1

An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

Options :

A : Executive board members.

B : Independent qualified individuals.

C : Regulatory authority expert advisors.

D : Investigators participating in the trial.

Answer: B

Question 2

Which of the following should be considered when implementing a risk-based monitoring plan?

Options :

A : 100% source document review is mandatory.

B : Centralized monitoring must be incorporated in any trials.

C : Monitoring schedule must be pre-defined in the monitoring plan.

D : On-site monitoring frequency may change depending on the quality of the data.

Answer: D

Question 3

Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

Options :

A : 1.8 mg/dL

B : 2.6 mg/dL

C : 3.0 mg/dL

D : 3.6 mg/dL

Answer: C

Question 4

In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

Options :

A : A total of five members.

B : One member whose primary area of interest is in the same scientific area.

C : One member of the site-s QA group.

D : One member who is independent of the institution/trial site.

Answer: D

Question 5

Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

Options :

A : Protocol, informed consent, and clinical trial agreement

B : IB, site coordinator CVs, and information about payments and compensation available to subjects

C : Protocol, IB, and information about payments and compensation available to subjects

D : Protocol, site coordinator CVs, and clinical trial agreement

Answer: C

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