Practice Test

100 Questions  I  By Ilogvinov
Please take the quiz to rate it.

Practice Test
This test is for internal department use only.

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


Questions and Answers Excerpt

Removing question excerpt is a premium feature

Upgrade and get a lot more done!
1.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
2.  The composition of the board where prisoners are involved shall meet the following requirements:
A.
B.
C.
D.
3.  A test article includes all of the following except for _______.
A.
B.
C.
D.
4.  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.
5.  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.
6.  _______ means any experiment that involves a test article and one or more human subjects.
A.
B.
C.
D.
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.  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.
9.  ______ are not considered to be a vulnerable population.
A.
B.
C.
D.
10.  An IND may be submitted for one or more phases of an investigation.
A.
B.
11.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
12.  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.
13.  The quality assurance unit shall assure management that ____ are in conformance with the regulations.
A.
B.
C.
D.
14.  An individual may not serve as an advocate for more than one child.
A.
B.
15.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
16.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
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.  _______ 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.
19.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
20.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
21.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
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.  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.
24.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
25.  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.
26.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
27.  An IRB can consist of all members in the same profession.
A.
B.
28.  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.
29.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
30.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
31.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
32.  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.
33.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
34.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
35.  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.
36.  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.
37.  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.
38.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
39.  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.
40.  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.
41.  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.
42.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
43.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
44.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
45.  Investigational new drug means a _______ that is used in a clinical investigation.
A.
B.
C.
D.
46.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
47.  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.
48.  The term "parent" can refer to an adoptive parent.
A.
B.
49.  An IRB can do the following:
A.
B.
C.
D.
50.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
51.  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.
52.  FDA stands for the ________.
A.
B.
C.
D.
53.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
54.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
55.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
56.  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.
57.  Together with the Institutional Review Board/Independent Ethics Committee, the _______ share the responsibility for the protection of clinical trial subjects.
A.
B.
C.
D.
58.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
59.  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.
60.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
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.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
63.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
64.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
65.  When the IRB determines that assent is required, it also must determine whether and how assent must be documented.
A.
B.
66.  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.
67.  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.
68.  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.
69.  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.
70.  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.
71.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
72.  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.
73.  ______ 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.
74.  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.
75.  Which of the following is not an additional duty of the IRB where prisoners are involved:
A.
B.
C.
D.
76.  CFR stands for ______.
A.
B.
C.
D.
77.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
78.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
79.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
80.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
81.  DOD stands for _______.
A.
B.
C.
D.
82.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
83.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
84.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
85.  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.
86.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
87.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
88.  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.
89.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
90.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
91.  ______ 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.
92.  The ______ has overall responsibility for the technical conduct of the study.
A.
B.
C.
D.
93.  Additional drug interaction, dose-response, and safety studies are some examples of a ______ study.
A.
B.
C.
D.
94.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
95.  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.
96.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
97.  Activities involving a dead fetus shall be conducted only in accordance with any applicable state or local laws regarding such activities.
A.
B.
98.  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.
99.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
100.  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.
Back to top

Removing ad is a premium feature

Upgrade and get a lot more done!
Take Another Quiz
We have sent an email with your new password.