SoCRA CERTIFICATION EXAM AND PRACTICE EXAM
20232024 ACTUAL EXAMS 200 QUESTIONS AND
CORRECT DETAILED ANSWERS WITH RATIONALES
(VERIFIED ANSWERS) | ALREADY GRADED A+
If an IRB disagrees with the sponsors determination that a device is non-significant risk who needs to be
notified?
A. The manufacturer
B. OHRP
C. FDA
D. The institution - ANSWER-C. FDA
If a device is determined to be Non-significant Risk it does not need to be labeled as investigational
A. True
B. False - ANSWER-B. False
Which devices typically only require general controls?
A. Class I
B. Class II
C. Class III
D. HUDs - ANSWER-A. Class I
A custom device not being tested for commercial distribution is exempt from IDE requirements.
A. True
B. False - ANSWER-A. True
If changes are made to the investigational plan for a device study a _______ must be submitted to the
FDA.
A. Protocol Amendment
B. Supplemental Application
,C. A Modification
D. Nothing, the FDA does not need to be notified - ANSWER-B. Supplemental Application
A diagnostic device is exempt from IDE requirements if:
A. It is noninvasive
B. It does not require an invasive sampling procedure
C. It does not introduce energy into the subject
D. It is not used as a diagnostic procedure without confirmation by an established procedure
E. All of the above - ANSWER-E. All of the above
If an IRB disagrees with the sponsor's non-significant risk determination how many days does the
sponsor have to report to the FDA?
A.10
B. 5
C. 15
D. 30 - ANSWER-B. 5
Drug-eluting stent, a nicotine patch, surgical mesh with antibiotic coating, and prefilled syringes are
examples of:
A. Drugs
B. Devices
C. Combination Products
D. HUDs - ANSWER-C. Combination Products
When is a 510(k) used?
A. To investigate a Class II device
B. For a Premarket Approval
C. To demonstrate substantial equivalence to a legally marketed device
D. All of the above - ANSWER-C. To demonstrate substantial equivalence to a legally marketed device
,A sponsor must obtain an IDE from the FDA in order to test a non-significant risk device.
A. True
B. False - ANSWER-B. False
A medical device:
A. Diagnoses, cures, lessens, treats or prevents disease
B. Affects the function or structure of the body
C. Does not achieve its primary intended purposes through chemical action
D. All of the above - ANSWER-D. All of the above
Emergency use of a test article may occur prior to IRB approval, provided the use is reported to the IRB
within how many working days?
A. 15 Days
B. 7 Days
C. 3 Days
D. 5 Days - ANSWER-D. 5 Days
Who has responsibility to control the investigational devices?
A. Investigator
B. Sponsor
C. FDA
D. Study Coordinator - ANSWER-A. Investigator
A medical device intended for the treatment or diagnosis of a disease that affects fewer than 8000
individuals in the US each year is:
A. IDE
B. IND
C. HUD
, D. HDE - ANSWER-C. HUD
When evaluating the causality of a suspected adverse reaction which of the following should be a
consideration?
A. Whether the event is listed in the investigator's brochure.
B. Whether the event is otherwise uncommon in the population exposed to the drug.
C. The method used to randomize subjects
D. The number of planned interventions in the protocol - ANSWER-B. Whether the event is otherwise
uncommon in the population exposed to the drug.
Accurate reporting of adverse events is most important for
A. Updating recruitment materials.
B. Allowing re-challenge of subjects.
C. Ensuring correct site reimbursement for work performed.
D. Ensuring subject safety. - ANSWER-D. Ensuring subject safety.
A subject of a research study is a passenger in a car involved in a motor vehicle crash. The subject
sustained a broken wrist and mild concussion. The subject was treated and released from the
emergency department. What should the investigator do when learning of the crash?
A. Report adverse events of both a broken wrist and a mild concussion to the Sponsor according to the
timetable specified in the protocol.
B. No report is needed because the subject was a passenger in the vehicle and not driving.
C. No report is needed because these are not serious adverse events.
D. Report both a broken wrist and a mild concussion to the Sponsor immediately. - ANSWER-A. Report
adverse events of both a broken wrist and a mild concussion to the Sponsor according to the timetable
specified in the protocol.
A subject presents to the emergency department (ED) with complaints of chest pain and shortness of
breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a
history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a
Phase 1 study of a new lipid lowering agent. Which individual should determine causality of the serious
adverse event?
A. Pharmacist
20232024 ACTUAL EXAMS 200 QUESTIONS AND
CORRECT DETAILED ANSWERS WITH RATIONALES
(VERIFIED ANSWERS) | ALREADY GRADED A+
If an IRB disagrees with the sponsors determination that a device is non-significant risk who needs to be
notified?
A. The manufacturer
B. OHRP
C. FDA
D. The institution - ANSWER-C. FDA
If a device is determined to be Non-significant Risk it does not need to be labeled as investigational
A. True
B. False - ANSWER-B. False
Which devices typically only require general controls?
A. Class I
B. Class II
C. Class III
D. HUDs - ANSWER-A. Class I
A custom device not being tested for commercial distribution is exempt from IDE requirements.
A. True
B. False - ANSWER-A. True
If changes are made to the investigational plan for a device study a _______ must be submitted to the
FDA.
A. Protocol Amendment
B. Supplemental Application
,C. A Modification
D. Nothing, the FDA does not need to be notified - ANSWER-B. Supplemental Application
A diagnostic device is exempt from IDE requirements if:
A. It is noninvasive
B. It does not require an invasive sampling procedure
C. It does not introduce energy into the subject
D. It is not used as a diagnostic procedure without confirmation by an established procedure
E. All of the above - ANSWER-E. All of the above
If an IRB disagrees with the sponsor's non-significant risk determination how many days does the
sponsor have to report to the FDA?
A.10
B. 5
C. 15
D. 30 - ANSWER-B. 5
Drug-eluting stent, a nicotine patch, surgical mesh with antibiotic coating, and prefilled syringes are
examples of:
A. Drugs
B. Devices
C. Combination Products
D. HUDs - ANSWER-C. Combination Products
When is a 510(k) used?
A. To investigate a Class II device
B. For a Premarket Approval
C. To demonstrate substantial equivalence to a legally marketed device
D. All of the above - ANSWER-C. To demonstrate substantial equivalence to a legally marketed device
,A sponsor must obtain an IDE from the FDA in order to test a non-significant risk device.
A. True
B. False - ANSWER-B. False
A medical device:
A. Diagnoses, cures, lessens, treats or prevents disease
B. Affects the function or structure of the body
C. Does not achieve its primary intended purposes through chemical action
D. All of the above - ANSWER-D. All of the above
Emergency use of a test article may occur prior to IRB approval, provided the use is reported to the IRB
within how many working days?
A. 15 Days
B. 7 Days
C. 3 Days
D. 5 Days - ANSWER-D. 5 Days
Who has responsibility to control the investigational devices?
A. Investigator
B. Sponsor
C. FDA
D. Study Coordinator - ANSWER-A. Investigator
A medical device intended for the treatment or diagnosis of a disease that affects fewer than 8000
individuals in the US each year is:
A. IDE
B. IND
C. HUD
, D. HDE - ANSWER-C. HUD
When evaluating the causality of a suspected adverse reaction which of the following should be a
consideration?
A. Whether the event is listed in the investigator's brochure.
B. Whether the event is otherwise uncommon in the population exposed to the drug.
C. The method used to randomize subjects
D. The number of planned interventions in the protocol - ANSWER-B. Whether the event is otherwise
uncommon in the population exposed to the drug.
Accurate reporting of adverse events is most important for
A. Updating recruitment materials.
B. Allowing re-challenge of subjects.
C. Ensuring correct site reimbursement for work performed.
D. Ensuring subject safety. - ANSWER-D. Ensuring subject safety.
A subject of a research study is a passenger in a car involved in a motor vehicle crash. The subject
sustained a broken wrist and mild concussion. The subject was treated and released from the
emergency department. What should the investigator do when learning of the crash?
A. Report adverse events of both a broken wrist and a mild concussion to the Sponsor according to the
timetable specified in the protocol.
B. No report is needed because the subject was a passenger in the vehicle and not driving.
C. No report is needed because these are not serious adverse events.
D. Report both a broken wrist and a mild concussion to the Sponsor immediately. - ANSWER-A. Report
adverse events of both a broken wrist and a mild concussion to the Sponsor according to the timetable
specified in the protocol.
A subject presents to the emergency department (ED) with complaints of chest pain and shortness of
breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a
history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a
Phase 1 study of a new lipid lowering agent. Which individual should determine causality of the serious
adverse event?
A. Pharmacist
