We have sent an email with your new password.


Practice Test

100 Questions  I  By Ilogvinov
Online Test Quizzes & Trivia
This test is for internal department use only.

   or Create Online Test
Changes are done, please start the quiz.


Question Excerpt

Removing question excerpt is a premium feature

Upgrade and get a lot more done!
1.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
2.  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.
3.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
4.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
5.  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.
6.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
7.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
8.  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.
9.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
10.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
11.  The contents of a protocol should generally contain:
A.
B.
C.
D.
12.  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.
13.  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.
14.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
15.  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.
16.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
17.  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.
18.  A test article includes all of the following except for _______.
A.
B.
C.
D.
19.  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.
20.  ______ 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.
21.  The term "parent" can refer to an adoptive parent.
A.
B.
22.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
23.  ______ 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.
24.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
25.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
26.  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.
27.  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.
28.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
29.  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.
30.  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.
31.  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.
32.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
33.  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.
34.  ________ 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.
35.  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.
36.  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.
37.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
38.  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.
39.  An individual may not serve as an advocate for more than one child.
A.
B.
40.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
41.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
42.  CFR stands for ______.
A.
B.
C.
D.
43.  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.
44.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
45.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
46.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
47.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
48.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
49.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
50.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
51.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
52.  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.
53.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
54.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
55.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
56.  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.
57.  A protocol is required to contain ________.
A.
B.
C.
D.
58.  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.
59.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
60.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
61.  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.
62.  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.
63.  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.
64.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
65.  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.
66.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
67.  IND means ______.
A.
B.
C.
D.
68.  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.
69.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
70.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
71.  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.
72.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
73.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
74.  FDA stands for the ________.
A.
B.
C.
D.
75.  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.
76.  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.
77.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
78.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
79.  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.
80.  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.
81.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
82.  An IRB can do the following:
A.
B.
C.
D.
83.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
84.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
85.  An IND may be submitted for one or more phases of an investigation.
A.
B.
86.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
87.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
88.  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.
89.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
90.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
91.  DOD stands for _______.
A.
B.
C.
D.
92.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
93.  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.
94.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
95.  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.
96.  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.
97.  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.
98.  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.
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.  IRB stands for _______.
A.
B.
C.
D.
Back to top

Removing ad is a premium feature

Upgrade and get a lot more done!
Take Another Quiz