Practice Test

100 Questions  I  By Ilogvinov
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1.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
2.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
3.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
4.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
5.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
6.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
7.  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.
8.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
9.  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.
10.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
11.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
12.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
13.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
14.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
15.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
16.  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.
17.  Each IRB shall have at least _______ members, with varying background to promote complte and adequate review of the research activities at their institution.
A.
B.
C.
D.
18.  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.
19.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
20.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
21.  The term "parent" can refer to an adoptive parent.
A.
B.
22.  The contents of a protocol should generally contain:
A.
B.
C.
D.
23.  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.
24.  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.
25.  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.
26.  CFR stands for ______.
A.
B.
C.
D.
27.  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.
28.  Any investigation commenced before July 27, 1981, and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date still requires IRB review.
A.
B.
29.  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.
30.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
31.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
32.  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.
33.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
34.  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.
35.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
36.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
37.  An IRB can consist of all members in the same profession.
A.
B.
38.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
39.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
40.  FDA stands for the ________.
A.
B.
C.
D.
41.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
42.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
43.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
44.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
45.  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.
46.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
47.  A test article includes all of the following except for _______.
A.
B.
C.
D.
48.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
49.  IRB stands for _______.
A.
B.
C.
D.
50.  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.
51.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
52.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
53.  An individual may not serve as an advocate for more than one child.
A.
B.
54.  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.
55.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
56.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
57.  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.
58.  DOD stands for _______.
A.
B.
C.
D.
59.  ________ 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.
60.  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.
61.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
62.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
63.  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.
64.  If an IRB uses an expedited review procedure, the other IRB members do not have to be informed of the research proposals which have been approved by expedited review.
A.
B.
65.  An IND may be submitted for one or more phases of an investigation.
A.
B.
66.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
67.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
68.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
69.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
70.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
71.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
72.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
73.  A protocol is required to contain ________.
A.
B.
C.
D.
74.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
75.  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.
76.  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.
77.  If the research presents no more than minimal risk or harm and involves no procedure for which written consent is normally required outside the research content, the IRB may waive the requirement for a signed written consent form.
A.
B.
78.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
79.  When there are sponsor representatives on the Independent Data Monitoring Committee, their role should be clearly defined in the committee's operating procedures.
A.
B.
80.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
81.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
82.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
83.  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.
84.  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.
85.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
86.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
87.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
88.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
89.  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.
90.  An IRB can do the following:
A.
B.
C.
D.
91.  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.
92.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
93.  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.
94.  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.
95.  IND means ______.
A.
B.
C.
D.
96.  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.
97.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
98.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
99.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
100.  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.
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