Practice Test

100 Questions  I  By Ilogvinov on September 3, 2009
This test is for internal department use only.

  

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1.  The only way an IRB member may participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest is to provide information to the IRB.
A.
B.
2.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
3.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
4.  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.
5.  The term "parent" can refer to an adoptive parent.
A.
B.
6.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
7.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
8.  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.
9.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
10.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
11.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
12.  CFR stands for ______.
A.
B.
C.
D.
13.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
14.  IRB stands for _______.
A.
B.
C.
D.
15.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
16.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
17.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
18.  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.
19.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
20.  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.
21.  The term _______ as used in section 520(g) of the act is deemed to be synonymous with the term institution for purposes of this part.
A.
B.
C.
D.
22.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
23.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
24.  The safety and tolerability properties of a drug are commonly summarized across studies continuously during an investigational product's development, and in particular, for the submission of a marketing application.
A.
B.
25.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
26.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
27.  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.
28.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
29.  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.
30.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
31.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
32.  A _______ trial has the primary objective of showing that the reponse to the investigational product is superior to a comparative agent.
A.
B.
C.
D.
33.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
34.  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.
35.  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.
36.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
37.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
38.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
39.  ______ means that the probability of and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
A.
B.
C.
D.
40.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
41.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
42.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
43.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
44.  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.
45.  _______ 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.
46.  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.
47.  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.
48.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
49.  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.
50.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
51.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
52.  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.
53.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
54.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
55.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
56.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
57.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
58.  In combination with blinding, ________ helps to avoid possible bias in the selection and allocation of subjects arising from the predictability of treatment assignments.
A.
B.
C.
D.
59.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
60.  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.
61.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
62.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
63.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
64.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
65.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
66.  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.
67.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
68.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
69.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
70.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
71.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
72.  FDA stands for the ________.
A.
B.
C.
D.
73.  An individual may not serve as an advocate for more than one child.
A.
B.
74.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
75.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
76.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
77.  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.
78.  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.
79.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
80.  ______ means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.
A.
B.
C.
D.
81.  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.
82.  An IRB can consist of all members in the same profession.
A.
B.
83.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
84.  Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to formal completion of a trial is an interim analysis.
A.
B.
85.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
86.  The purpose of an IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and the welfare of human subjects.
A.
B.
87.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
88.  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.
89.  IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.
A.
B.
90.  ________ is a technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be identical.
A.
B.
C.
D.
91.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
92.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
93.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
94.  An overall summary and synthesis of the evidence on safety and efficacy from all the reported clinical trials is not required for a marketing application.
A.
B.
95.  In order for the IRB to approve research, the IRB shall determine that all of the following requirements have been met:
A.
B.
C.
D.
96.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
97.  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.
98.  An IRB shall conduct continuing review of research covered at intervals appropriate to the degree of risk, but not _______ a year.
A.
B.
C.
D.
99.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
100.  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.
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