Practice Test

100 Questions  I  By Ilogvinov on September 3, 2009
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1.  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.
2.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
3.  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.
4.  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.
5.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
6.  An IRB can do the following:
A.
B.
C.
D.
7.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
8.  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.
9.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
10.  An IND may be submitted for one or more phases of an investigation.
A.
B.
11.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
12.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
13.  IND means ______.
A.
B.
C.
D.
14.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
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B.
C.
D.
15.  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.
16.  The term "parent" can refer to an adoptive parent.
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B.
17.  In general, protocols for ______ studies may be less detailed and more flexible.
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B.
C.
D.
18.  Which of the following is not an additional duty of the IRB where prisoners are involved:
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B.
C.
D.
19.  _______ means a child's affirmative agreement to participate in research.
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B.
C.
D.
20.  The contents of a protocol should generally contain:
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B.
C.
D.
21.  For a double blind study, ________ are unaware of the treatment assignments.
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B.
C.
D.
22.  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.
23.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
24.  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.
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B.
C.
D.
25.  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.
26.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
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B.
27.  For an IRB, there must be at least one member ________.
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B.
C.
D.
28.  If the clinical investigation involves more than minimal risk and no prospect of direct benefit, children may only be involved if the ______ provides approval.
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B.
C.
D.
29.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
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B.
30.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
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B.
31.  _______ are expanded controlled and uncontrolled trials.
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B.
C.
D.
32.  Subpart D deals with clinical investigations for _________ .
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B.
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D.
33.  ________ is a technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be identical.
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B.
C.
D.
34.  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.
35.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
36.  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.
37.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
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B.
C.
D.
38.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
39.  Sponsor means a person who does not initiate a clinical investigation.
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B.
40.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
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B.
C.
D.
41.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
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B.
C.
D.
42.  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?
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B.
43.  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.
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B.
C.
D.
44.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
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B.
C.
D.
45.  CFR stands for ______.
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B.
C.
D.
46.  If the short form method is utilized, the witness shall sign _______.
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B.
C.
D.
47.  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.
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B.
48.  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.
49.  Clinical investigation means any experiment that involves a test article and no human subjects.
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B.
50.  A representative of the _____ shall have access to the written procedures established for the inspection.
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B.
C.
D.
51.  A test article includes all of the following except for _______.
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B.
C.
D.
52.  ______ studies usually include from several hundred to several thousand subjects.
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B.
C.
D.
53.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
54.  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.
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B.
55.  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.
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B.
56.  The informed consent shall contain a description of ________.
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B.
C.
D.
57.  An IRB shall conduct continuing review of research covered at intervals appropriate to the degree of risk, but not _______ a year.
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B.
C.
D.
58.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
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B.
59.  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.
60.  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 _______.
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B.
C.
D.
61.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
62.  When there are sponsor representatives on the Independent Data Monitoring Committee, their role should be clearly defined in the committee's operating procedures.
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B.
63.  If a clinical investigation is approved, the IRB must require appointment of a/an ______ for each child who is a ward.
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B.
C.
D.
64.  Investigational new drug means a _______ that is used in a clinical investigation.
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B.
C.
D.
65.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
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B.
C.
D.
66.  A pregnant woman may be involved as a subject in an activity covered in Subpart B if the risk to the fetus is minimal.
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B.
67.  ______ means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.
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B.
C.
D.
68.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
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B.
69.  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.
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B.
70.  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.
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B.
C.
D.
71.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
72.  ______ 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.
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B.
C.
D.
73.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
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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.
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B.
75.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
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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.  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 ________.
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B.
C.
D.
78.  A _______ trial has the primary objective of showing that the reponse to the investigational product is superior to a comparative agent.
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B.
C.
D.
79.  Testing facility management may replace the study director during the conduct of the study.
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B.
80.  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.
81.  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).
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B.
C.
D.
82.  An individual may not serve as an advocate for more than one child.
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B.
83.  For a Phase 2 study, which of the following statements is not correct:
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B.
C.
D.
84.  Depending on the drug and endpoint studied, pharmacodynamic studies and studies relating to drug blood levels to response (PK/PD) may be conducted in _________.
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B.
C.
D.
85.  An IRB can consist of all members in the same profession.
A.
B.
86.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
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B.
87.  A waiver request is required to contain at least _______.
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B.
C.
D.
88.  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.
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B.
C.
D.
89.  A statement that participation is voluntary is a ________.
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B.
C.
D.
90.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
91.  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.
92.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
93.  Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if ________.
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B.
C.
D.
E.
94.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
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B.
C.
D.
95.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
96.  In reporting adverse events for a trial , you will need to report ________ adverse events.
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B.
C.
D.
97.  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.
98.  ________ means an individual who actually conducts a clinical investigation.
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B.
C.
D.
99.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
100.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
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