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100 Questions  I  By Ilogvinov
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1.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
2.  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.
3.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
4.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
5.  IND means ______.
A.
B.
C.
D.
6.  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.
7.  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.
8.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
9.  An IRB can do the following:
A.
B.
C.
D.
10.  DOD stands for _______.
A.
B.
C.
D.
11.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
12.  The term "parent" can refer to an adoptive parent.
A.
B.
13.  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.
14.  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.
15.  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.
16.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
17.  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.
18.  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.
19.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
20.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
21.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
22.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
23.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
24.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
25.  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.
26.  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.
27.  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.
28.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
29.  IRB stands for _______.
A.
B.
C.
D.
30.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
31.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
32.  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.
33.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
34.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
35.  FDA stands for the ________.
A.
B.
C.
D.
36.  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.
37.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
38.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
39.  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.
40.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
41.  An IRB can consist of all members in the same profession.
A.
B.
42.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
43.  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.
44.  A protocol is required to contain ________.
A.
B.
C.
D.
45.  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.
46.  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.
47.  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.
48.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
49.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
50.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
51.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
52.  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.
53.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
54.  ______ 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.
55.  The contents of a protocol should generally contain:
A.
B.
C.
D.
56.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
57.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
58.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
59.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
60.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
61.  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.
62.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
63.  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.
64.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
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 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.
67.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
68.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
69.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
70.  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.
71.  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.
72.  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.
73.  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.
74.  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.
75.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
76.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
77.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
78.  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.
79.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
80.  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.
81.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
82.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
83.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
84.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
85.  ________ 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.
86.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
87.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
88.  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.
89.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
90.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
91.  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.
92.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
93.  An IND may be submitted for one or more phases of an investigation.
A.
B.
94.  CFR stands for ______.
A.
B.
C.
D.
95.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
96.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
97.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
98.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
99.  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.
100.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
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