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100 Questions  I  By Ilogvinov
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1.  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.
2.  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.
3.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
4.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
5.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
6.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
7.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
8.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
9.  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.
10.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
11.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
12.  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.
13.  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.
14.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
15.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
16.  The formal evaluation of the quantitative evidence from two or more trials bearing the same question is known as a _______.
A.
B.
C.
D.
17.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
18.  A ______ fetus means a fetus ex utero which, although living, is not viable.
A.
B.
C.
D.
19.  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.
20.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
21.  An IRB can do the following:
A.
B.
C.
D.
22.  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.
23.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
24.  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.
25.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
26.  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.
27.  The term "parent" can refer to an adoptive parent.
A.
B.
28.  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.
29.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
30.  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.
31.  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.
32.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
33.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
34.  A test article includes all of the following except for _______.
A.
B.
C.
D.
35.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
36.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
37.  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.
38.  A protocol is required to contain ________.
A.
B.
C.
D.
39.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
40.  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.
41.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
42.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
43.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
44.  IND means ______.
A.
B.
C.
D.
45.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
46.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
47.  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.
48.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
49.  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.
50.  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.
51.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
52.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
53.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
54.  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.
55.  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.
56.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
57.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
58.  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.
59.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
60.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
61.  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.
62.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
63.  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.
64.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
65.  _______ 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.
66.  DOD stands for _______.
A.
B.
C.
D.
67.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
68.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
69.  ______ 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.
70.  ________ 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.
71.  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.
72.  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.
73.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
74.  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.
75.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
76.  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.
77.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
78.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
79.  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.
80.  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.
81.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
82.  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.
83.  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.
84.  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.
85.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
86.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
87.  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.
88.  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.
89.  An IND may be submitted for one or more phases of an investigation.
A.
B.
90.  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.
91.  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.
92.  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.
93.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
94.  An IRB can consist of all members in the same profession.
A.
B.
95.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
96.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
97.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
98.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
99.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
100.  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.
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