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100 Questions  I  By Ilogvinov
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1.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
2.  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.
3.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
4.  IND means ______.
A.
B.
C.
D.
5.  CFR stands for ______.
A.
B.
C.
D.
6.  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.
7.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
8.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
9.  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.
10.  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.
11.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
12.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
13.  A waiver request is required to contain at least _______.
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.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
16.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
17.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
18.  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.
19.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
20.  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.
21.  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.
22.  The term "parent" can refer to an adoptive parent.
A.
B.
23.  An IND may be submitted for one or more phases of an investigation.
A.
B.
24.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
25.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
26.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
27.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
28.  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.
29.  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.
30.  The contents of a protocol should generally contain:
A.
B.
C.
D.
31.  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.
32.  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.
33.  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.
34.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
35.  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.
36.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
37.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
38.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
39.  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.
40.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
41.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
42.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
43.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
44.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
45.  IRB stands for _______.
A.
B.
C.
D.
46.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
47.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
48.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
49.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
50.  FDA stands for the ________.
A.
B.
C.
D.
51.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
52.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
53.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
54.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
55.  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.
56.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
57.  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.
58.  ________ 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.
59.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
60.  DOD stands for _______.
A.
B.
C.
D.
61.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
62.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
63.  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.
64.  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.
65.  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.
66.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
67.  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.
68.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
69.  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.
70.  ______ 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.
71.  An IRB can consist of all members in the same profession.
A.
B.
72.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
73.  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).
A.
B.
C.
D.
74.  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.
75.  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.
76.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
77.  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.
78.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
79.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
80.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
81.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
82.  ______ 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.
83.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
84.  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.
85.  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.
86.  An IRB can do the following:
A.
B.
C.
D.
87.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
88.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
89.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
90.  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.
91.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
92.  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.
93.  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.
94.  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.
95.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
96.  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.
97.  A protocol is required to contain ________.
A.
B.
C.
D.
98.  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.
99.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
100.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
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