Question 1

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 2

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 3

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 4

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 5

In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

Options :

A : A total of five members.

B : One member whose primary area of interest is in the same scientific area.

C : One member of the site-s QA group.

D : One member who is independent of the institution/trial site.

Answer: D

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