Question 1

A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

Options :

A : Yes, the PI has a sufficient patient population to take part in this study.

B : No, the PI does not have the resources to perform all protocol-required procedures.

C : Yes, the PI can perform other imaging scans instead of the PET scans.

D : No, the PI is taking part in too many ongoing studies to participate in this study.

Answer: B

Question 2

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

Question 3

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 4

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 5

A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

Options :

A : Redact subject identification for privacy protection.

B : Deny the request until the sponsor approves.

C : Allow access to the entire records.

D : Consult with the IRB/IEC first.

Answer: C

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