Question 1

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 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 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 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

Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

Options :

A : 1.8 mg/dL

B : 2.6 mg/dL

C : 3.0 mg/dL

D : 3.6 mg/dL

Answer: C

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