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

The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

Options :

A : A witness

B : A family member

C : A member of the research team

D : A legally acceptable representative

Answer: D

Question 3

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 4

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 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