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

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

Which of the following should be considered when implementing a risk-based monitoring plan?

Options :

A : 100% source document review is mandatory.

B : Centralized monitoring must be incorporated in any trials.

C : Monitoring schedule must be pre-defined in the monitoring plan.

D : On-site monitoring frequency may change depending on the quality of the data.

Answer: D

Question 5

A protocol amendment is needed to collect additional data from a participant’s medical record. When can the research team begin collecting the additional data?

Options :

A : When the need for the additional data is discovered

B : After the original planned data collection is completed

C : After the protocol amendment is approved by the IRB/IEC

D : As soon as the protocol amendment is submitted to the IRB/IEC

Answer: C

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