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

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

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

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

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