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100 Questions  I  By Ilogvinov
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1.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
2.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
3.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
4.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
5.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
6.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
7.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
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8.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
9.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
10.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
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.
B.
C.
D.
12.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
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13.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
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.
B.
C.
D.
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.
B.
C.
D.
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.
B.
C.
D.
17.  Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if ________.
A.
B.
C.
D.
E.
Discuss this Question
18.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
19.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
20.  If a clinical investigation is approved, the IRB must require appointment of a/an ______ for each child who is a ward.
A.
B.
C.
D.
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.
B.
22.  FDA stands for the ________.
A.
B.
C.
D.
23.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
24.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
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.
B.
26.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
27.  IND means ______.
A.
B.
C.
D.
28.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
29.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
30.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
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31.  An IND may be submitted for one or more phases of an investigation.
A.
B.
32.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
33.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
34.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
35.  A protocol is required to contain ________.
A.
B.
C.
D.
36.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
37.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
38.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
39.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
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.
B.
C.
D.
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.
B.
C.
D.
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.
B.
43.  DOD stands for _______.
A.
B.
C.
D.
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.
B.
C.
D.
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.
B.
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.
B.
C.
D.
47.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
48.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
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.
B.
C.
D.
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.
B.
C.
D.
51.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
52.  A test article includes all of the following except for _______.
A.
B.
C.
D.
53.  The ______ means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in research.
A.
B.
C.
D.
54.  _______ means a child who is placed in the legal custody of the state or other agency, institution, or entity, consistent with federal, state, or local law.
A.
B.
C.
D.
55.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
56.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
57.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
58.  IRB stands for _______.
A.
B.
C.
D.
59.  CFR stands for ______.
A.
B.
C.
D.
60.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
61.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
62.  Protocols involving an exception to the informed consent requirement under Section 50.24 must be performed under a separate investigational new drug application or investigational device exemption that clearly identifies such protocols as protocols that may include subjects who are unable to consent.
A.
B.
63.  The IRB responsible for the review, approval, and continuing review of the clinical investigation described in Section 50.24 may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is not a member of or consultant to the IRB and who is participating in the clinical investigation).
A.
B.
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64.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
65.  A statement that significant new findings developed during the course of the research which may relate tot he subject's willingness to continue participation will be provided to the subject is a/an _______.
A.
B.
C.
D.
66.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
67.  If the legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, does the subject need to be informed of the clinical investigation?
A.
B.
68.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
69.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
70.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
71.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
72.  A pregnant woman may be involved as a subject in an activity covered in Subpart B if the risk to the fetus is minimal.
A.
B.
73.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
74.  The product of conception from the implantation time, until a determination is made, following expulsion or extraction, that it is viable is known as a ________.
A.
B.
C.
D.
75.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
Discuss this Question
76.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
77.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
78.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
79.  The regulations in Subpart C are applicable to the biomedical and behavioral research conducted by the Department of Health and Human Services involving _______ as subjects.
A.
B.
C.
D.
80.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
81.  The probability and magnitude of physical or psychological harm that is normally encountered in daily lives of healthy persons is known as _______.
A.
B.
C.
D.
82.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
83.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
84.  The term "parent" can refer to an adoptive parent.
A.
B.
85.  An individual may not serve as an advocate for more than one child.
A.
B.
86.  An individual who is authorized under state or local law to consent on behalf of a child for general medical care is know as a ________.
A.
B.
C.
D.
87.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
88.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
89.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
90.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
91.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
92.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
93.  Phase 2 is usually considered to start with the initiation of studies in which the secondary objective is to explore the therapeutic efficacy in animals
A.
B.
94.  Depending on the drug and endpoint studied, pharmacodynamic studies and studies relating to drug blood levels to response (PK/PD) may be conducted in _________.
A.
B.
C.
D.
95.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
96.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
Discuss this Question
97.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
98.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
99.  The primary endpoint should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial.
A.
B.
100.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
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