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

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 3

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 4

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

Question 5

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