Question 1

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 2

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 3

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 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

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

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