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Practice Test

100 Questions  I  By Ilogvinov
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1.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
2.  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.
3.  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.
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.  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.
7.  An individual may not serve as an advocate for more than one child.
A.
B.
8.  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.
9.  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.
10.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
11.  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.
12.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
13.  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.
14.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
15.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
16.  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.
17.  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.
18.  An IRB can consist of all members in the same profession.
A.
B.
19.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
20.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
21.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
22.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
23.  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.
24.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
25.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
26.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
27.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
28.  A protocol is required to contain ________.
A.
B.
C.
D.
29.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
30.  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.
31.  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.
32.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
33.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
34.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
35.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
36.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
37.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
38.  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.
39.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
40.  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.
41.  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.
42.  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.
43.  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.
44.  ______ 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.
45.  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.
46.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
47.  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.
48.  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.
49.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
50.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
51.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
52.  IND means ______.
A.
B.
C.
D.
53.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
54.  The contents of a protocol should generally contain:
A.
B.
C.
D.
55.  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.
56.  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.
57.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
58.  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.
59.  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.
60.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
61.  _______ 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.
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.  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.
64.  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.
65.  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.
66.  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.
67.  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.
68.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
69.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
70.  FDA stands for the ________.
A.
B.
C.
D.
71.  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.
72.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
73.  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.
74.  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.
75.  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.
76.  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.
77.  A test article includes all of the following except for _______.
A.
B.
C.
D.
78.  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.
79.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
80.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
81.  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.
82.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
83.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
84.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
85.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
86.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
87.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
88.  IRB stands for _______.
A.
B.
C.
D.
89.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
90.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
91.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
92.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
93.  An IND may be submitted for one or more phases of an investigation.
A.
B.
94.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
95.  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.
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.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
98.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
99.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
100.  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.
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