2009 RAC Practice Exam Questions with
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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).
A 510(k) submission for any Class III device MUST include:
A. Clinical results summary.
B. Risk analysis.
C. Stability evaluation.
D. Certification and summary. - Answer -D. Certification and summary.
As required by 21 CFR 807.87(j), a 510(k) for a Class III device must include a Class III certification and
summary as defined in 21 CFR 807.3(p and q) and 807.94.
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).
A company has been given a product from its British subsidiary to market for the first time in the US. The
product is marketed in the EU. A project team gathered by the regulatory professional to review the
information available for regulatory submission to FDA should:
A. Focus on labeling and marketing since mutual recognition does not require complete technical
review.
B. Include production, marketing, QA and clinical research for a thorough review.
C. Summarize financial data and distribution data which are normally required to be submitted to FDA.
D. Not be necessary if a Common Technical Document has been prepared by the subsidiary. -
Answer -B. Include production, marketing, QA and clinical research for a thorough review.
A company has found a way to produce its drug product more economically; however, the current
manufacturing process would have to be changed substantially. What would be the most appropriate
post-approval vehicle for this potential action?
A. Post-Approval Supplement: Changes Being Effected - Immediate (CBE 0).
B. Post-Approval Supplement: Changes Being Effected in 30 Days (CBE 30).
C. Prior approval supplement.
D. Annual report. - Answer -C. Prior approval supplement.
Changes made under this designation are considered to be major, representing a high potential to have
an adverse effect on the identity, strength, quality, purity or potency of a drug product. Since the
changes to the current manufacturing process are substantial, the potential of the proposed change(s) to
adversely effect the identity, strength, quality, purity or potency of the drug product is high and, thus,
represent(s) a major change. See FDA's "Guidance for Industry Changes to an Approved NDA or ANDA.
See also 21CFR §314.70(b).
A company has received a 10-page FDA-483. The regulatory affairs professional's supervisor has
prepared a detailed response assuring the FDA district office that corrective action has been taken for
each observation. Which of the following should be done?
,A. Re-audit the company's corrective actions before the letter is sent.
B. Re-audit the company's corrective actions within three months because FDA usually conducts re-
inspections within six months.
C. Re-audit the company's corrective actions during the next scheduled audit.
D. Re-audit the company's corrective actions immediately after the letter is sent. - Answer -A. Re-
audit the company's corrective actions before the letter is sent.
The letter from the supervisor states the corrective actions have already taken place. The firm may be
subject to inspection at any time; therefore, these corrections should be reviewed. Title 18 of the US
Code makes submitting false information to the government a criminal offense.
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.
A company wants to modify its device such that there is a major change to the fundamental scientific
technology of the device. The FDA has published a guidance on this technology and special controls have
been established. This change would be best filed as a(n):
A. Special 510(k).
B. Abbreviated 510(k).
C. Traditional 510(k).
D. PMA. - Answer -B. Abbreviated 510(k).
, An abbreviated 510(k) is allowed in this case because there is a published guidance and special controls
for the device exist. The abbreviated 510(k) route may allow for a more expeditious review by the FDA
than a traditional 510(k). See the CDRH guidance published in 1998 entitled "The New 510(k) Paradigm -
Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".
A company's competitor is marketing a Class II suture which dissolves during the third week of use. The
company's current product has to be removed by a physician. However, a change in weaving
configuration gives this product the same dissolving time as the competitor's. When can the company's
new suture be marketed?
A. This requires a new 510(k) since significant change in product instructions might affect efficacy.
B. After submission in a periodic report.
C. After reporting clinical studies in an annual report.
D. After submission of labeling change. - Answer -A. This requires a new 510(k) since significant
change in product instructions might affect efficacy.
A new intended use requires a 510(k) clearance.
A company's supplier of the active drug substance for the company's OTC drug product informs the
company that the supplier will be moving their production of the drug substance from the current plant
to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing
processes will remain the same and the specifications will not change. The company intends to qualify
the change suitably. How should the company report the change to FDA?
The change only needs to be reported in an annual report because the company will qualify the change
and the supplier said the process and specifications won't change.
B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval
supplement) because it is a change to the drug substance manufacturing location.
C. The change does not have to be reported because it is an OTC drug.
D. Not enough information. - Answer -D. Not enough information.
It is unclear from this question if the OTC drug product is an OTC monograph product for which there
would be no FDA administrative file to report the change to, or if this is an NDA-OTC drug product
(versus an NDA-Rx drug product). For an NDA-OTC drug product, the company would have an approved
NDA file where they could send a supplement for review.
A defective product was released into distribution and has caused patient injuries. The patients were
treated in a local hospital and may suffer further reversible medical consequences as a result of the
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Perfect Score
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).
A 510(k) submission for any Class III device MUST include:
A. Clinical results summary.
B. Risk analysis.
C. Stability evaluation.
D. Certification and summary. - Answer -D. Certification and summary.
As required by 21 CFR 807.87(j), a 510(k) for a Class III device must include a Class III certification and
summary as defined in 21 CFR 807.3(p and q) and 807.94.
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).
A company has been given a product from its British subsidiary to market for the first time in the US. The
product is marketed in the EU. A project team gathered by the regulatory professional to review the
information available for regulatory submission to FDA should:
A. Focus on labeling and marketing since mutual recognition does not require complete technical
review.
B. Include production, marketing, QA and clinical research for a thorough review.
C. Summarize financial data and distribution data which are normally required to be submitted to FDA.
D. Not be necessary if a Common Technical Document has been prepared by the subsidiary. -
Answer -B. Include production, marketing, QA and clinical research for a thorough review.
A company has found a way to produce its drug product more economically; however, the current
manufacturing process would have to be changed substantially. What would be the most appropriate
post-approval vehicle for this potential action?
A. Post-Approval Supplement: Changes Being Effected - Immediate (CBE 0).
B. Post-Approval Supplement: Changes Being Effected in 30 Days (CBE 30).
C. Prior approval supplement.
D. Annual report. - Answer -C. Prior approval supplement.
Changes made under this designation are considered to be major, representing a high potential to have
an adverse effect on the identity, strength, quality, purity or potency of a drug product. Since the
changes to the current manufacturing process are substantial, the potential of the proposed change(s) to
adversely effect the identity, strength, quality, purity or potency of the drug product is high and, thus,
represent(s) a major change. See FDA's "Guidance for Industry Changes to an Approved NDA or ANDA.
See also 21CFR §314.70(b).
A company has received a 10-page FDA-483. The regulatory affairs professional's supervisor has
prepared a detailed response assuring the FDA district office that corrective action has been taken for
each observation. Which of the following should be done?
,A. Re-audit the company's corrective actions before the letter is sent.
B. Re-audit the company's corrective actions within three months because FDA usually conducts re-
inspections within six months.
C. Re-audit the company's corrective actions during the next scheduled audit.
D. Re-audit the company's corrective actions immediately after the letter is sent. - Answer -A. Re-
audit the company's corrective actions before the letter is sent.
The letter from the supervisor states the corrective actions have already taken place. The firm may be
subject to inspection at any time; therefore, these corrections should be reviewed. Title 18 of the US
Code makes submitting false information to the government a criminal offense.
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.
A company wants to modify its device such that there is a major change to the fundamental scientific
technology of the device. The FDA has published a guidance on this technology and special controls have
been established. This change would be best filed as a(n):
A. Special 510(k).
B. Abbreviated 510(k).
C. Traditional 510(k).
D. PMA. - Answer -B. Abbreviated 510(k).
, An abbreviated 510(k) is allowed in this case because there is a published guidance and special controls
for the device exist. The abbreviated 510(k) route may allow for a more expeditious review by the FDA
than a traditional 510(k). See the CDRH guidance published in 1998 entitled "The New 510(k) Paradigm -
Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".
A company's competitor is marketing a Class II suture which dissolves during the third week of use. The
company's current product has to be removed by a physician. However, a change in weaving
configuration gives this product the same dissolving time as the competitor's. When can the company's
new suture be marketed?
A. This requires a new 510(k) since significant change in product instructions might affect efficacy.
B. After submission in a periodic report.
C. After reporting clinical studies in an annual report.
D. After submission of labeling change. - Answer -A. This requires a new 510(k) since significant
change in product instructions might affect efficacy.
A new intended use requires a 510(k) clearance.
A company's supplier of the active drug substance for the company's OTC drug product informs the
company that the supplier will be moving their production of the drug substance from the current plant
to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing
processes will remain the same and the specifications will not change. The company intends to qualify
the change suitably. How should the company report the change to FDA?
The change only needs to be reported in an annual report because the company will qualify the change
and the supplier said the process and specifications won't change.
B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval
supplement) because it is a change to the drug substance manufacturing location.
C. The change does not have to be reported because it is an OTC drug.
D. Not enough information. - Answer -D. Not enough information.
It is unclear from this question if the OTC drug product is an OTC monograph product for which there
would be no FDA administrative file to report the change to, or if this is an NDA-OTC drug product
(versus an NDA-Rx drug product). For an NDA-OTC drug product, the company would have an approved
NDA file where they could send a supplement for review.
A defective product was released into distribution and has caused patient injuries. The patients were
treated in a local hospital and may suffer further reversible medical consequences as a result of the
