Question 1

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 2

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 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

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

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

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