Practice Test

100 Questions  I  By Ilogvinov
Practice Test
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1.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
2.  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.
3.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
4.  ______ 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.
5.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
6.  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.
7.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
8.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
9.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
10.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
11.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
12.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
13.  According to FDA guidelines, the financial disclosure form should be completed by all study personnel that have a significant role in the study.
A.
B.
14.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
15.  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.
16.  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.
17.  IND means ______.
A.
B.
C.
D.
18.  ______ 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.
19.  If 500 subjects were enrolled on a clinical trial and 10 subjects were excluded from the analysis, the report will only reflect the 490 subjects.
A.
B.
20.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
21.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
22.  An IND may be submitted for one or more phases of an investigation.
A.
B.
23.  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.
24.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
25.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
26.  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.
27.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
28.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
29.  An individual may not serve as an advocate for more than one child.
A.
B.
30.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
31.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
32.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
33.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
34.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
35.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
36.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
37.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
38.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
39.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
40.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
41.  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.
42.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
43.  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.
44.  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.
45.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
46.  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.
47.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
48.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
49.  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.
50.  ________ 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.
51.  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.
52.  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.
53.  FDA stands for the ________.
A.
B.
C.
D.
54.  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.
55.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
56.  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.
57.  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.
58.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
59.  A test article includes all of the following except for _______.
A.
B.
C.
D.
60.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
61.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
62.  IRB stands for _______.
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 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.
65.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
66.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
67.  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.
68.  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.
69.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
70.  The use of a test article on a human subject in a life-threatening situation in which there is no standard acceptable treatment, and in which there is not sufficient tiem to obtain IRB approval is known as emergency use.
A.
B.
71.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
72.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
73.  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.
74.  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.
75.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
76.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
77.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
78.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
79.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
80.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
81.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
82.  The contents of a protocol should generally contain:
A.
B.
C.
D.
83.  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.
84.  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.
85.  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.
86.  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.
87.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
88.  The term "parent" can refer to an adoptive parent.
A.
B.
89.  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.
90.  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.
91.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
92.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
93.  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.
94.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
95.  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.
96.  An IRB can do the following:
A.
B.
C.
D.
97.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
98.  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.
99.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
100.  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.
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