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100 Questions  I  By Ilogvinov
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1.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
2.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
3.  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.
4.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
5.  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.
6.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
7.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
8.  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.
9.  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.
10.  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.
11.  ______ 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.
12.  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.
13.  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.
14.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
15.  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.
16.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
17.  ________ 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.
18.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
19.  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.
20.  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.
21.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
22.  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.
23.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
24.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
25.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
26.  FDA stands for the ________.
A.
B.
C.
D.
27.  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.
28.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
29.  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.
30.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
31.  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.
32.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
33.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
34.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
35.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
36.  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.
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 ______ 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.
39.  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.
40.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
41.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
42.  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.
43.  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.
44.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
45.  IRB stands for _______.
A.
B.
C.
D.
46.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
47.  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.
48.  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.
49.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
50.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
51.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
52.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
53.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
54.  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.
55.  An IRB can consist of all members in the same profession.
A.
B.
56.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
57.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
58.  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.
59.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
60.  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.
61.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
62.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
63.  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.
64.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
65.  The term "parent" can refer to an adoptive parent.
A.
B.
66.  A test article includes all of the following except for _______.
A.
B.
C.
D.
67.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
68.  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.
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.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
71.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
72.  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.
73.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
74.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
75.  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.
76.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
77.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
78.  ______ 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.
79.  An IND may be submitted for one or more phases of an investigation.
A.
B.
80.  CFR stands for ______.
A.
B.
C.
D.
81.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
82.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
83.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
84.  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.
85.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
86.  An IRB can do the following:
A.
B.
C.
D.
87.  IND means ______.
A.
B.
C.
D.
88.  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.
89.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
90.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
91.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
92.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
93.  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.
94.  When determining whether children are capable of providing assent, the IRB must take into account ______.
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.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
97.  DOD stands for _______.
A.
B.
C.
D.
98.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
99.  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.
100.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
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