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100 Questions  I  By Ilogvinov
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1.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
2.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
3.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
4.  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.
5.  An IRB can do the following:
A.
B.
C.
D.
6.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
7.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
8.  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.
9.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
10.  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.
11.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
12.  A test article includes all of the following except for _______.
A.
B.
C.
D.
13.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
14.  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.
15.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
16.  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.
17.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
18.  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.
19.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
20.  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.
21.  ______ 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.
22.  IRB stands for _______.
A.
B.
C.
D.
23.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
24.  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.
25.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
26.  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.
27.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
28.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
29.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
30.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
31.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
32.  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.
33.  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.
34.  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.
35.  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.
36.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
37.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
38.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
39.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
40.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
41.  The term "parent" can refer to an adoptive parent.
A.
B.
42.  An individual may not serve as an advocate for more than one child.
A.
B.
43.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
44.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
45.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
46.  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.
47.  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.
48.  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.
49.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
50.  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.
51.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
52.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
53.  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.
54.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
55.  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.
56.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
57.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
58.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
59.  A protocol is required to contain ________.
A.
B.
C.
D.
60.  ______ 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.
61.  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.
62.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
63.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
64.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
65.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
66.  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.
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 pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
69.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
70.  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.
71.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
72.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
73.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
74.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
75.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
76.  _______ 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.
77.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
78.  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.
79.  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.
80.  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.
81.  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.
82.  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.
83.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
84.  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.
85.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
86.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
87.  DOD stands for _______.
A.
B.
C.
D.
88.  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.
89.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
90.  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.
91.  An IRB can consist of all members in the same profession.
A.
B.
92.  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.
93.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
94.  IND means ______.
A.
B.
C.
D.
95.  ________ 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.
96.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
97.  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.
98.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
99.  An IND may be submitted for one or more phases of an investigation.
A.
B.
100.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
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