Question 1

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 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

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

Question 4

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 5

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

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