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100 Questions  I  By Ilogvinov
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1.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
2.  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.
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.  FDA stands for the ________.
A.
B.
C.
D.
5.  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.
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.  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.
8.  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.
9.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
10.  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.
11.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
12.  _______ 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.
13.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
14.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
15.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
16.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
17.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
18.  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.
19.  DOD stands for _______.
A.
B.
C.
D.
20.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
21.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
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.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
24.  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.
25.  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.
26.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
27.  A protocol is required to contain ________.
A.
B.
C.
D.
28.  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.
29.  ______ 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.
30.  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.
31.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
32.  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.
33.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
34.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
35.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
36.  ________ 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.
37.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
38.  IND means ______.
A.
B.
C.
D.
39.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
40.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
41.  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.
42.  An individual may not serve as an advocate for more than one child.
A.
B.
43.  An IRB can consist of all members in the same profession.
A.
B.
44.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
45.  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.
46.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
47.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
48.  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.
49.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
50.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
51.  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.
52.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
53.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
54.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
55.  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.
56.  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.
57.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
58.  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.
59.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
60.  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.
61.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
62.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
63.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
64.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
65.  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.
66.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
67.  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.
68.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
69.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
70.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
71.  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.
72.  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.
73.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
74.  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.
75.  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.
76.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
77.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
78.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
79.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
80.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
81.  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.
82.  The contents of a protocol should generally contain:
A.
B.
C.
D.
83.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
84.  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.
85.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
86.  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.
87.  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.
88.  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.
89.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
90.  CFR stands for ______.
A.
B.
C.
D.
91.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
92.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
93.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
94.  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.
95.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
96.  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.
97.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
98.  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.
99.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
100.  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.
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