Practice Test

100 Questions  I  By Ilogvinov
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1.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
2.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
3.  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.
4.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
5.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
6.  The term "parent" can refer to an adoptive parent.
A.
B.
7.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
8.  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.
9.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
10.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
11.  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.
12.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
13.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
14.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
15.  A protocol is required to contain ________.
A.
B.
C.
D.
16.  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.
17.  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.
18.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
19.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
20.  An IRB can do the following:
A.
B.
C.
D.
21.  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.
22.  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.
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.  DOD stands for _______.
A.
B.
C.
D.
25.  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.
26.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
27.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
28.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
29.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
30.  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.
31.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
32.  ______ 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.
33.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
34.  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.
35.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
36.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
37.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
38.  IND means ______.
A.
B.
C.
D.
39.  An individual may not serve as an advocate for more than one child.
A.
B.
40.  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.
41.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
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.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
44.  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.
45.  ______ 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.
46.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
47.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
48.  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.
49.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
50.  When determining whether children are capable of providing assent, the IRB must take into account ______.
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.  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.  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.
54.  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.
55.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
56.  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.
57.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
58.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
59.  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.
60.  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.
61.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
62.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
63.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
64.  ________ 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.
65.  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.
66.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
67.  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.
68.  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.
69.  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.
70.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
71.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
72.  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.
73.  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.
74.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
75.  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.
76.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
77.  IRB stands for _______.
A.
B.
C.
D.
78.  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.
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.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
81.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
82.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
83.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
84.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
85.  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.
86.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
87.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
88.  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.
89.  An IND may be submitted for one or more phases of an investigation.
A.
B.
90.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
91.  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.
92.  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.
93.  An IRB can consist of all members in the same profession.
A.
B.
94.  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.
95.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
96.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
97.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
98.  CFR stands for ______.
A.
B.
C.
D.
99.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
100.  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.
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