RAC Practice Exam 2009 Questions and Answers All Correct
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RAC
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RAC
RAC Practice Exam 2009 Questions and Answers All Correct
A sponsor submitted an original IDE/IND application. If the sponsor has not received any response from the FDA, what is the earliest that clinical studies can be initiated?
A. The sponsor must wait for FDA approval.
B. Upon IRB ap...
RAC Practice Exam 2009
Questions and Answers All
Correct
A sponsor submitted an original IDE/IND application. If the sponsor has not received
any response from the FDA, what is the earliest that clinical studies can be initiated?
A. The sponsor must wait for FDA approval.
B. Upon IRB approval from any study center.
C. 30 days from receipt by FDA.
D. 90 days from receipt by FDA. - Answer- C. 30 days from receipt by FDA.
The IDE/IND goes into effect 30 days after receipt by FDA, unless FDA notifies the
sponsor that the IDE/IND is on clinical hold. 21 CFR 812.30 (a)(1), 312.40(b)(1).
A clinical study sponsor's representative conducts periodic monitoring site visits for all of
the following purposes EXCEPT to:
A. Review raw data.
B. Ensure compliance with the protocol.
C. Review the protocol with the investigator.
D. Ensure the adequacy of the IRB and its procedures. - Answer- D. Ensure the
adequacy of the IRB and its procedures.
An institution conducting clinical investigations is responsible for the integrity of the IRB
and is held accountable. There is a degree of confidentiality that may not be breached
by a study monitor. The investigator, through the signed 1572 form, assures the
sponsor of IRB review. 21 CFR 812.100, 812.110; 21 CFR 312.66, 21 CFR
812.150(a)(2), 812.140(a)(1).
. Which of the following is NOT a responsibility of clinical investigators?
A. Submitting notices to the IRB of deviations from the investigational plan.
B. Maintaining records of receipt, use and disposi¬tion of investigational product.
C. Reporting to the sponsor withdrawal of IRB approval.
D. Submitting unanticipated adverse event reports to FDA. - Answer- D. Submitting
unanticipated adverse event reports to FDA.
,It is the responsibility of the sponsor to notify FDA once notified by the investigator. The
investigator is responsible for notifying both the sponsor and the IRB. 21CFR 312.60,
812.140,150(a) (1).
All of the following are requirements of an IRB EXCEPT that it:
A. Is composed of at least five members.
B. Includes at least one non-scientific member.
C. Obtains informed consent from all subjects.
D. Represents the cultural mix of the community. - Answer- C. Obtains informed
consent from all subjects.
It is the responsibility of the clinical investigator to obtain informed consent from all
subjects, not the IRB. 21 CFR 312.60.
During a monitoring visit, the sponsor discovers that an investigator had used a device
in a clinical investigation without obtaining informed consent from the subject. Which of
the following should the regulatory affairs professional do?
A. Predate the informed consent with a memo to the site file.
B. Contact the patient to obtain the informed consent immediately.
C. Ensure that the study director for the sponsor discusses the issue with the
investigator.
D. Report the protocol deviation to the IRB. - Answer- C. Ensure that the study director
for the sponsor discusses the issue with the investigator.
[per 812.150(a)(5) and (b)(8)]
Which of the following does NOT discuss the protection of human subjects?
A. Nuremberg Code.
B. Declaration of Helsinki.
C. Drug Amendment of 1962.
D. Food Drug and Cosmetic Act of 1938. - Answer- D. Food Drug and Cosmetic Act of
1938.
A company is using a clinical research organization (CRO) to develop the protocol and
monitor the clinical investigators for the company's clinical trial. The regulatory affairs
professional may interact with the CRO in which of the following situations?
A. Making presentations to the reviewing IRBs.
B. Making presentations to the reviewing division at FDA.
C. Witnessing the signing of patient consent forms.
D. Arranging for FDA investigators to observe treatment of subjects at clinical sites. -
Answer- B. Making presentations to the reviewing division at FDA.
, The CRO may assist the company in explaining the clinical protocol or data to FDA.
Which of the following changes require FDA approval of NDA supplements before the
change is made?
A. Adding an additional test method.
B. Deleting a dye from the drug product.
C. Making changes that comply with USP.
D. Relaxing the limits for a drug substance specification. - Answer- D. Relaxing the
limits for a drug substance specification.
Prior FDA approval is required for a noncompendial relaxation of release specification
limits. 21 CFR 314.70.
According to the drug regulations, the FDA will most likely put an IND study on clinical
hold for which of the following reasons:
A. Human subjects are exposed to a reasonable degree (non-significant) or risk of
illness or injury by participating in the trial.
B. The manufacturer charges a fee for the investigational product.
C. The clinical investigators are qualified by scientific training or experience to conduct
the study described in the investigator's brochure.
D. The sponsor is not pursuing marketing approval with due diligence. - Answer- D.
The sponsor is not pursuing marketing approval with due diligence.
The sponsor must be pursuing marketing approval by diligently pursuing timely studies
and commercialization per 21CFR312.42.
In conformance with GMP, which of the following departments is responsible for
approving or rejecting finished pharmaceuticals?
A. Regulatory affairs.
B. Quarantine and inspection.
C. Quality control.
D. Operations. - Answer- C. Quality control
QC has the responsibility and authority to approve or reject final products, 21 CFR
211.22. Establishment of a Quality system is a requirement for QSR, 21 CFR 820.5,
820.20, 820.22, 820.80. Additional information is available in Medical Device Quality
Systems Manual: A Small Entity Compliance Guide. GTPs also mandate establishment
of a Quality Program, 21 CFR 1271.160.
Which of the following is NOT true regarding ANDAs filed under paragraph IV
certification?
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