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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.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
3.  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.
4.  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.
5.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
6.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
7.  DOD stands for _______.
A.
B.
C.
D.
8.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
9.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
10.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
11.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
12.  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.
13.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
14.  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.
15.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
16.  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.
17.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
18.  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.
19.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
20.  An IND may be submitted for one or more phases of an investigation.
A.
B.
21.  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.
22.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
23.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
24.  IND means ______.
A.
B.
C.
D.
25.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
26.  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.
27.  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.
28.  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.
29.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
30.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
31.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
32.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
33.  An IRB can do the following:
A.
B.
C.
D.
34.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
35.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
36.  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.
37.  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.
38.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
39.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
40.  FDA stands for the ________.
A.
B.
C.
D.
41.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
42.  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.
43.  ______ 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.
44.  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.
45.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
46.  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.
47.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
48.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
49.  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.
50.  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.
51.  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.
52.  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.
53.  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.
54.  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.
55.  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.
56.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
57.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
58.  An individual may not serve as an advocate for more than one child.
A.
B.
59.  ________ means an individual who actually conducts a clinical investigation.
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.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
62.  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.
63.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
64.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
65.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
66.  An IRB can consist of all members in the same profession.
A.
B.
67.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
68.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
69.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
70.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
71.  _______ 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.
72.  A test article includes all of the following except for _______.
A.
B.
C.
D.
73.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
74.  The contents of a protocol should generally contain:
A.
B.
C.
D.
75.  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.
76.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
77.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
78.  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.
79.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
80.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
81.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
82.  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.
83.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
84.  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.
85.  ______ 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.
86.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
87.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
88.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
89.  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.
90.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
91.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
92.  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.
93.  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.
94.  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.
95.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
96.  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.
97.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
98.  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.
99.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
100.  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.
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