Phases Of An Investigation Quiz Questions
This test is for internal department use only.
- 1.
The ______ has overall responsibility for the technical conduct of the study.
- A.
Study coordinator
- B.
Research nurse
- C.
Study director
- D.
All of the above
Correct Answer
C. Study directorExplanation
21 CFR 58.33Rate this question:
-
- 2.
Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 58.33 (c)Rate this question:
-
- 3.
The quality assurance unit shall assure management that ____ are in conformance with the regulations.
- A.
Personnel
- B.
Equipment
- C.
Methods
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
21 CFR 58.35 (a)Rate this question:
-
- 4.
A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
21 CFR 58.35 (11)Rate this question:
-
- 5.
A representative of the _____ shall have access to the written procedures established for the inspection.
- A.
OHRP
- B.
Study director
- C.
FDA
- D.
None of the above
Correct Answer
C. FDAExplanation
21 CFR 58.35 (d)Rate this question:
-
- 6.
Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
- A.
Current summary of training
- B.
Current summary of experience
- C.
A job description
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
21 CFR 58.29 (b)Rate this question:
-
- 7.
Testing facility management may replace the study director during the conduct of the study.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 58.31 (b)Rate this question:
-
- 8.
The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
- A.
Study director
- B.
Study coordinator
- C.
Quality assurance unit
- D.
All of the above
Correct Answer
C. Quality assurance unitExplanation
21 CFR 58.35 (21)Rate this question:
-
- 9.
Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
21 CFR 58.29 (e)Rate this question:
-
- 10.
The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 58.35 (7)Rate this question:
-
- 11.
A/An ______ must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation.
- A.
Advocate
- B.
Parent
- C.
Witness
- D.
None of the above
Correct Answer
A. AdvocateExplanation
21 CFR 50.56(b)(3)Rate this question:
-
- 12.
Subpart D deals with clinical investigations for _________ .
- A.
Adults
- B.
Children
- C.
Vulnerable persons
- D.
All of the above
Correct Answer
B. ChildrenExplanation
21 CFR 50.50Rate this question:
-
- 13.
Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 50.56(a)Rate this question:
-
- 14.
Where parental permission is to be obtained, the IRB may find that the permission of ________ is sufficient, if consistent with state law, for clinical investigations to be conducted under 50.51 and 50.52.
- A.
Both parents
- B.
One parent
- C.
A legally authorized representative
- D.
All of the above
Correct Answer
B. One parentExplanation
21 CFR 50.55(e)(1)Rate this question:
-
- 15.
Clinical investigation involving greater than minimal risk but presenting the prospect of direct benefit may involve children as subjects only if the IRB finds and documents that ______.
- A.
The risk is justified by the anticipated benefit
- B.
Adequate provisions are made for soliciting the assent of the children and permission of their parents and guardians
- C.
The relation of the anticipate benefits to the risk is at least as favorable to the subjects as presented by the alternatives
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
21 CFR 50.52(a-c)Rate this question:
-
- 16.
If the clinical investigation involves more than minimal risk and no prospect of direct benefit, children may only be involved if the ______ provides approval.
- A.
IRB
- B.
Parent
- C.
Child
- D.
All of the above
Correct Answer
A. IRBExplanation
21 CFR 50.53Rate this question:
-
- 17.
Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if ________.
- A.
The clinical investigation involves no more than minimal risk
- B.
The waiver will adversely affect the rights and welfare of the subjects
- C.
The clinical investigation could not practically be carried out without the waiver
- D.
All of the above
- E.
A and c
Correct Answer
E. A and cExplanation
21 CFR 50.55(d)(1 and 3)Rate this question:
-
- 18.
When determining whether children are capable of providing assent, the IRB must take into account ______.
- A.
Maturity
- B.
Ages
- C.
Psychological state of the children involved
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
21 CFR 50.55(b)Rate this question:
-
- 19.
When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 50.55(g)Rate this question:
-
- 20.
If a clinical investigation is approved, the IRB must require appointment of a/an ______ for each child who is a ward.
- A.
Parent
- B.
Advocate
- C.
Guardian
- D.
All of the above
Correct Answer
B. AdvocateExplanation
21 CFR 50.56(b)Rate this question:
-
- 21.
A clinical investigation involving the use of a placebo is exempt from the requirements of this part if the investigation does not otherwise submission of an IND.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 312.2(5)Rate this question:
-
- 22.
FDA stands for the ________.
- A.
Food and Device Administration
- B.
Freedom and Drug Association
- C.
Food and Drug Administration
- D.
Food and Drug Association
Correct Answer
C. Food and Drug AdministrationExplanation
21 CFR 312.3(b)Rate this question:
-
- 23.
________ means an individual who actually conducts a clinical investigation.
- A.
Clinical Research Organization
- B.
Food and Drug Administration
- C.
Sponsor
- D.
Investigator
Correct Answer
D. InvestigatorExplanation
21 CFR 312.3(b)Rate this question:
-
- 24.
Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 312.3(b)Rate this question:
-
- 25.
After the sponsor has found that the results of an investigation appear to establish sufficient data to support a marketing application, it is acceptable for the sponsor to prolong the investigation.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
21 CFR 312.7(c)Rate this question:
-
- 26.
A waiver request is required to contain at least _______.
- A.
Other information justifying a waiver
- B.
A description of alternative submission or course of action
- C.
An explanation of why the sponsor's compliance with the requirement is unnecessary or cannot be achieved
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
21 CFR 312.10(a)Rate this question:
-
- 27.
IND means ______.
- A.
Investigation new drug application
- B.
Investigational new drug application
- C.
Investigator new drug application
- D.
Investigational new device application
Correct Answer
B. Investigational new drug applicationExplanation
21 CFR 312.3(b)Rate this question:
-
- 28.
Investigational new drug means a _______ that is used in a clinical investigation.
- A.
New biological drug
- B.
New drug
- C.
All of the above
- D.
None of the above
Correct Answer
C. All of the aboveExplanation
21 CFR 312.3(b)Rate this question:
-
- 29.
An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
- A.
Safety
- B.
Rights
- C.
Well-being
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
21 CFR 312.3(b)Rate this question:
-
- 30.
The contract research organization assumes all of the following for a sponsor except for ______.
- A.
Evaluation of reports
- B.
Accrual of subjects
- C.
Design of the protocol
- D.
Preparation of materials to be submitted to the FDA
Correct Answer
B. Accrual of subjectsExplanation
21 CFR 312.3(b)Rate this question:
-
- 31.
An IND may be submitted for one or more phases of an investigation.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
21 CFR 312.21Rate this question:
-
- 32.
The FDA shall provide a written determination ______ after FDA received the IND or earlier.
- A.
15 days
- B.
30 days
- C.
2 months
- D.
1 year
Correct Answer
B. 30 daysExplanation
21 CFR 312.20(c)Rate this question:
-
- 33.
______ studies usually include from several hundred to several thousand subjects.
- A.
Phase 1
- B.
Phase 2
- C.
Phase 3
- D.
All of the above
Correct Answer
C. Phase 3Explanation
21 CFR 312.21(c)Rate this question:
-
- 34.
In general, protocols for ______ studies may be less detailed and more flexible.
- A.
Phase 1
- B.
Phase 2
- C.
Phase 3
- D.
All of the above
Correct Answer
A. Phase 1Explanation
21 CFR 312.23(6)Rate this question:
-
- 35.
A protocol is required to contain ________.
- A.
A description of the observations and measurements to fulfill the study's objectives
- B.
A description of the clinical procedures and laboratory procedures
- C.
A statement of the objectives and purpose
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
21 CFR 312.23(6)(iii)Rate this question:
-
- 36.
For a Phase 2 study, which of the following statements is not correct:
- A.
They include several hundred to several thousand subjects.
- B.
They are well controlled.
- C.
They are closely monitored.
- D.
They usually involve no more than several hundred subjects
Correct Answer
A. They include several hundred to several thousand subjects.Explanation
21 CFR 312.21(c)Rate this question:
-
- 37.
_______ are expanded controlled and uncontrolled trials.
- A.
Phase 1
- B.
Phase 2
- C.
Phase 3
- D.
All of the above
Correct Answer
C. Phase 3Explanation
21 CFR 312.21(c)Rate this question:
-
- 38.
Phase 1 studies may be conducted in ______.
- A.
Patients
- B.
Animals
- C.
Normal volunteer subjects
- D.
A and c
Correct Answer
D. A and cExplanation
21 CFR 312.21(a)Rate this question:
-
- 39.
The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
- A.
Protocol
- B.
Amendment
- C.
IND
- D.
Waiver
Correct Answer
C. INDExplanation
21 CFR 312.20(a)Rate this question:
-
- 40.
The sponsor shall submit a/an _____ of all submissions to the IND file, including the original submission and all of the amendments and reports.
- A.
Two copies
- B.
Three copies
- C.
Original and two copies
- D.
One copy
Correct Answer
C. Original and two copiesExplanation
21 CFR 312.23Rate this question:
-
- 41.
The obtaining of informed consent shall be deemed feasible unless, before use of test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing that _______.
- A.
The human subject is confronted by a life-threatening situation
- B.
Time is not sufficient to obtain consent from the subject's legal representative
- C.
Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from the subject
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
21 CFR 50.23(a)(1-3)Rate this question:
-
- 42.
The information that is given to a subject or the representative does not need to be in a language understandable to the subject or the representative.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
21 CFR 50.20Rate this question:
-
- 43.
DOD stands for _______.
- A.
Division of Defense
- B.
Department of Direction
- C.
Department of Defense
- D.
None of the above
Correct Answer
C. Department of DefenseExplanation
21 CFR 50.23(d)(1)Rate this question:
-
- 44.
The ________ may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation.
- A.
Secretary of Defense
- B.
Vice President
- C.
President
- D.
All of the above
Correct Answer
C. PresidentExplanation
21 CFR 50.23(d)(1)Rate this question:
-
- 45.
The sponsor will provide training to the appropriate medical personnel and potential recipients on the specific investigation new drug to be administered prior to its use.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
21 CFR 50.23(d)(1)(xiv)Rate this question:
-
- 46.
The _______ is responsible for ensuring the adequacy of the information required in Section 50.25 (except for the information described in 50.25(a)(8).
- A.
IRB
- B.
Sponsor
- C.
Investigator
- D.
Department of Defense
Correct Answer
A. IRBExplanation
21 CFR 50.23(e)(5)Rate this question:
-
- 47.
The documentation required after using a test article shall be submitted to the IRB within _____ working days.
- A.
Five
- B.
Three
- C.
Ten
- D.
Seven
Correct Answer
A. FiveExplanation
21 CFR 50.23(c)Rate this question:
-
- 48.
Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
- A.
Protocol
- B.
Consent form
- C.
Written information sheet
- D.
None of the above
Correct Answer
C. Written information sheetExplanation
21 CFR 50.23(d)(1)(viii)Rate this question:
-
- 49.
The ______ provide adequate follow-up to assess whether there are beneficial or adverse health consequences that result from the use of the investigational product.
- A.
President
- B.
Secretary of Defense
- C.
Department of Defense
- D.
None of the above
Correct Answer
C. Department of DefenseExplanation
21 CFR 50.23(d)(1)(xi)Rate this question:
-
- 50.
The duly constituted IRB, must include at least ______ non-affiliated members who shall not be employees or officers of the Federal Government and shall be required to obtain any necessary security clearances.
- A.
Five
- B.
Three
- C.
Two
- D.
One
Correct Answer
B. ThreeExplanation
21 CFR 50.23(d)(2)Rate this question:
-
Quiz Review Timeline +
Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.
-
Current Version
-
Mar 22, 2023Quiz Edited by
ProProfs Editorial Team -
Sep 03, 2009Quiz Created by
Ilogvinov
Back to top