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Sample Questions
RAC-GS Sample Question 1
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
A. Instructions for use
B. Risk analysis
C. Product literature
D. Essential principles
ANSWER : A,B
RAC-GS Sample Question 2
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?
A. The minimum number of attendees necessary to address the issues
B. All senior management from the main office
C. As many as government attendees
D. As many as required by international standards
ANSWER : A
RAC-GS Sample Question 3
A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?
A. Concept development and validation
B. Concept development and early technical design
C. Early technical design and product release
D. Product release and validation
ANSWER : B
RAC-GS Sample Question 4
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
A. Proposed dose and volume of administration
B. Biological activity with species and/or tissue specificity
C. Immunochemical and functional tests
D. Proposed product route and frequency of administration
ANSWER : B
RAC-GS Sample Question 5
The requirements for document control are located in which of the following documents?
A. ICH guidelines
B. IEC 60601
C. ISO 13485
D. WHO guidelines
ANSWER : C
RAC-GS Sample Question 6
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
A. Plasma fractionation
B. Product distribution
C. Individual plasma donation
D. Plasma pooling
ANSWER : B
RAC-GS Sample Question 7
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic. What should be done in response to identifying the impurity?
A. Perform either an identification study or a non-clinical qualification study.
B. Perform both identification and non-clinical qualification studies concurrently.
C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
D. Perform a non-clinical qualification study, wait until the result is available, and then
consider performing an identification study.
ANSWER : C
RAC-GS Sample Question 8
Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?
A. Active-controlled
B. Cross-over
C. Dose-ranging
D. Placebo-controlled
ANSWER : B
RAC-GS Sample Question 9
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
A. Fishbone analysis
B. Failure modes, effects, and criticality analysis
C. Fault tree analysis
D. Quality by design analysis
ANSWER : B
RAC-GS Sample Question 10
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation. However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
A. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
B. Inform the internal departments to redesign the product to comply with this requirement.
C. Inform the regulatory authority that such a requirement is not applicable to the product.
D. Notify senior management that the product cannot be registered.
ANSWER : A
RAC-GS Sample Question 11
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?
A. Safety and failure risk
B. Safety and effectiveness
C. Quality and failure risk
D. Quality and effectiveness
ANSWER : B
RAC-GS Sample Question 12
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
A. Site license
B. Product license
C. Import license
D. Export license
ANSWER : A
RAC-GS Sample Question 13
Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical Properties and Formulation" section of an IB?
A. A review of available data to support the determination of the chemical structure and
physical attributes of the drug substance plus batch analysis and stability data for the
finished formulation
B. A detailed summary of the physical and chemical properties of the drug product with a
signed expert statement addressing the suitability and stability of the formulation for its
intended use
C. A description and flow chart illustrating the synthetic route for the active ingredient and
the preparation method of the finished product
D. A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation
ANSWER : D
RAC-GS Sample Question 14
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?
A. The process information and analytical result of Company X API
B. The process information and analytical result of Company Y API
C. The process information and the comparative analytical result of APIs from both
companies
D. Information deemed appropriate by the regulatory authority
ANSWER : C
RAC-GS Sample Question 15
According to ICH, which of the following components of study information is NOT required in a clinical study report?
A. Randomization scheme and codes
B. Protocol and protocol amendments
C. ListoflECsorlRBs
D. Detailed CVofall investigators
ANSWER : D