Question 1

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 2

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 3

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 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

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