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Practice Test

100 Questions  I  By Ilogvinov
Practice Test
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1.  ________ 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.
2.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
3.  ______ 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.
4.  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.
5.  CFR stands for ______.
A.
B.
C.
D.
6.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
7.  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.
8.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
9.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
10.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
11.  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.
12.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
13.  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.
14.  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.
15.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
16.  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.
17.  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.
18.  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.
19.  _______ 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.
20.  IRB stands for _______.
A.
B.
C.
D.
21.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
22.  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.
23.  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.
24.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
25.  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.
26.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
27.  An IRB can consist of all members in the same profession.
A.
B.
28.  DOD stands for _______.
A.
B.
C.
D.
29.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
30.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
31.  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.
32.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
33.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
34.  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.
35.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
36.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
37.  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.
38.  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.
39.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
40.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
41.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
42.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
43.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
44.  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.
45.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
46.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
47.  A protocol is required to contain ________.
A.
B.
C.
D.
48.  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.
49.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
50.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
51.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
52.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
53.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
54.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
55.  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.
56.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
57.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
58.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
59.  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.
60.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
61.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
62.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
63.  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.
64.  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.
65.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
66.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
67.  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.
68.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
69.  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.
70.  A test article includes all of the following except for _______.
A.
B.
C.
D.
71.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
72.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
73.  An individual may not serve as an advocate for more than one child.
A.
B.
74.  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.
75.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
76.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
77.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
78.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
79.  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.
80.  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.
81.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
82.  An IND may be submitted for one or more phases of an investigation.
A.
B.
83.  The term "parent" can refer to an adoptive parent.
A.
B.
84.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
85.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
86.  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.
87.  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.
88.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
89.  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.
90.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
91.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
92.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
93.  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.
94.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
95.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
96.  FDA stands for the ________.
A.
B.
C.
D.
97.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
98.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
99.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
100.  IND means ______.
A.
B.
C.
D.
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