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100 Questions  I  By Ilogvinov
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1.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
2.  The contents of a protocol should generally contain:
A.
B.
C.
D.
3.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
4.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
5.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
6.  ______ 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.
7.  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.
8.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
9.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
10.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
11.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
12.  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.
13.  An IND may be submitted for one or more phases of an investigation.
A.
B.
14.  An IRB can do the following:
A.
B.
C.
D.
15.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
16.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
17.  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.
18.  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.
19.  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.
20.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
21.  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.
22.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
23.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
24.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
25.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
26.  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.
27.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
28.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
29.  ______ 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.
30.  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.
31.  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.
32.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
33.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
34.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
35.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
36.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
37.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
38.  ________ means an individual who actually conducts a clinical investigation.
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.  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.
41.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
42.  ________ 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.
43.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
44.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
45.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
46.  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.
47.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
48.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
49.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
50.  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.
51.  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.
52.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
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.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
55.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
56.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
57.  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.
58.  IND means ______.
A.
B.
C.
D.
59.  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.
60.  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.
61.  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.
62.  IRB stands for _______.
A.
B.
C.
D.
63.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
64.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
65.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
66.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
67.  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.
68.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
69.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
70.  The term "parent" can refer to an adoptive parent.
A.
B.
71.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
72.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
73.  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.
74.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
75.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
76.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
77.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
78.  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.
79.  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.
80.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
81.  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.
82.  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.
83.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
84.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
85.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
86.  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.
87.  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.
88.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
89.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
90.  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.
91.  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.
92.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
93.  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.
94.  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.
95.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
96.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
97.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
98.  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.
99.  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.
100.  FDA stands for the ________.
A.
B.
C.
D.
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