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Question 1

Source data/documentation should be:

Options :

A : Attributable, legible, contemporaneous, original, accurate, and complete.

B : Attributable, legible, contemporaneous, original, accurate, and clear.

C : Attributable, legible, correct, original, accurate, and complete.

D : Attributable, legible, correct, original, accurate, and clear.

Answer: A

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

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 4

Which document confirms the PI’s agreement to permit auditing at the study site?

Options :

A : IB

B : ICF

C : Protocol

D : Delegation Log

Answer: B

Question 5

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