Question 1

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

Question 2

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 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

A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

Options :

A : Notify the subject.

B : Withdraw the subject.

C : Notify the sponsor.

D : Notify the regulatory authority.

Answer: C

Question 5

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

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