During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on
the part of the PI. What action should the sponsor take?

• A.Inform the institution that granted a medical license to the Pi.
• B.Increase the frequency of monitoring visits.
• C.Send a letter of complaint to the Ethics Committee that approved the site.
• D.Terminate the PI and inform the regulatory authorities.

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Following the introduction of a new regulation, an evaluation of the company's products by the regulatory
affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

• A.Communicate with the relevant internal departments.
• B.Request a permanent waiver from the new regulation.
• C.Contact the trade association for advice.
• D.Prepare documents for the files.

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As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?

• A.Import license
• B.Export license
• C.Product license
• D.Site license

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Which term does NOT describe the same concept as the others?

• A.Biosimilars
• B.Subsequent entry biologics
• C.Monoclonal antibody
• D.Follow-on protein products

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Why is it necessary to run supplemental safety pharmacology studies?

• A.To substitute the utilization of GLP
• B.To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
• C.To provide adverse reaction reports and the results of the statistical data to the regulatory authority
• D.To comply with regulatory authority requirements related to clinical studies

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