Practice Test

100 Questions  I  By Ilogvinov
Practice Test
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1.  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.
2.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
3.  The contents of a protocol should generally contain:
A.
B.
C.
D.
4.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
5.  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.
6.  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.
7.  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.
8.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
9.  The term "parent" can refer to an adoptive parent.
A.
B.
10.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
11.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
12.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
13.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
14.  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.
15.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
16.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
17.  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.
18.  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.
19.  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.
20.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
21.  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.
22.  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.
23.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
24.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
25.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
26.  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.
27.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
28.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
29.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
30.  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.
31.  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.
32.  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.
33.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
34.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
35.  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.
36.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
37.  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.
38.  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.
39.  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.
40.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
41.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
42.  _______ 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.
43.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
44.  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.
45.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
46.  An IND may be submitted for one or more phases of an investigation.
A.
B.
47.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
48.  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.
49.  ______ 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.
50.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
51.  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.
52.  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.
53.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
54.  A test article includes all of the following except for _______.
A.
B.
C.
D.
55.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
56.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
57.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
58.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
59.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
60.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
61.  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.
62.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
63.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
64.  IND means ______.
A.
B.
C.
D.
65.  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.
66.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
67.  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.
68.  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.
69.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
70.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
71.  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.
72.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
73.  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.
74.  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.
75.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
76.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
77.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
78.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
79.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
80.  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.
81.  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.
82.  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.
83.  ________ 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.
84.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
85.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
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.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
88.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
89.  An IRB can consist of all members in the same profession.
A.
B.
90.  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.
91.  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.
92.  FDA stands for the ________.
A.
B.
C.
D.
93.  ______ 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.
94.  A protocol is required to contain ________.
A.
B.
C.
D.
95.  DOD stands for _______.
A.
B.
C.
D.
96.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
97.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
98.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
99.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
100.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
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