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1.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
2.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
3.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
4.  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.
5.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
6.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
7.  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.
8.  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.
9.  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.
10.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
11.  _______ 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.
12.  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.
13.  No fetus in utero may be involved as a subject in any activity covered by Subpart B unless _____.
A.
B.
C.
D.
14.  A test article includes all of the following except for _______.
A.
B.
C.
D.
15.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
16.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
17.  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.
18.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
19.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
20.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
21.  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.
22.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
23.  An IRB can do the following:
A.
B.
C.
D.
24.  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.
25.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
26.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
27.  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.
28.  For an industry sponsored trial, a site should allow only the sponsor's monitor access to the regulatory files.
A.
B.
29.  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.
30.  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.
31.  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.
32.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
33.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
34.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
35.  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.
36.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
37.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
38.  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.
39.  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.
Discuss this Question
40.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
41.  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.
42.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
43.  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.
Discuss this Question
44.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
45.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
46.  ________ 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.
Discuss this Question
47.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
48.  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.
49.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
50.  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.
51.  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.
52.  ______ 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.
53.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
54.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
Discuss this Question
55.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
56.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
57.  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.
58.  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.
59.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
60.  DOD stands for _______.
A.
B.
C.
D.
61.  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.
62.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
63.  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.
64.  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.
65.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
66.  The term "parent" can refer to an adoptive parent.
A.
B.
67.  ______ 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.
68.  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.
69.  An individual may not serve as an advocate for more than one child.
A.
B.
70.  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.
71.  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.
72.  When determining whether children are capable of providing assent, the IRB must take into account ______.
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.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
Discuss this Question
75.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
76.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
77.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
78.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
79.  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.
80.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
81.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
82.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
83.  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.
84.  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.
85.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
86.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
87.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
88.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
89.  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.
90.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
91.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
92.  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.
93.  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.
94.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
95.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
96.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
97.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
98.  What FDA document must all investigators sign prior to participating in a drug clinical trial?
A.
B.
C.
99.  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.
100.  The contents of a protocol should generally contain:
A.
B.
C.
D.
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