Practice Test

100 Questions  I  By Ilogvinov on September 3, 2009
This test is for internal department use only.

  

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1.  FDA stands for the ________.
A.
B.
C.
D.
2.  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.
3.  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.
4.  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.
5.  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.
6.  _______ are persons who have not attained the legal age for consent to treatments or procedures involved in the research.
A.
B.
C.
D.
7.  Any individual involuntarily confined or detained in a penal institution is known as prisoner.
A.
B.
8.  _______ are expanded controlled and uncontrolled trials.
A.
B.
C.
D.
9.  Blinding is intended to limit the occurrence of ________ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
10.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
11.  Inducements, monetary or otherwise, may be offered to terminate a pregnancy for purposes of the activity.
A.
B.
12.  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.
13.  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.
14.  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.
15.  Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.
A.
B.
16.  An IND may be submitted for one or more phases of an investigation.
A.
B.
17.  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.
18.  _______ means a child's affirmative agreement to participate in research.
A.
B.
C.
D.
19.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
20.  The _______ should be taken into account in selecting the subject population, as should prior non-clinical and clinical knowledge.
A.
B.
C.
D.
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.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
23.  ______ 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.
24.  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.
25.  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.
26.  The regulations in Subpart B are applicable to supporting research, development, and related activities involving the following:
A.
B.
C.
D.
27.  When a short form written consent document is used, there shall be a ________ to the oral presentation.
A.
B.
C.
D.
28.  The pre-analysis review blinded to study treatment should ______.
A.
B.
C.
D.
29.  Test article means any ______ under the act or under sections 351 or 354-360F of the Public Health Service Act.
A.
B.
C.
D.
30.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.
A.
B.
C.
D.
31.  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.
32.  No individual clinical trial can be expected to be totally representative of future uses because of possible influences of _______.
A.
B.
C.
D.
33.  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.
34.  Subpart D deals with clinical investigations for _________ .
A.
B.
C.
D.
35.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
36.    Pregnancy encompasses the period of time from implantation confirmation until expulsion or extraction of the fetus.
A.
B.
37.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
38.  The informed consent shall provide an explanation of whom to contact for answers to pertinent questions about the _______.
A.
B.
C.
D.
39.  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.
40.  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.
41.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
42.  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.
43.  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.
44.  CFR stands for ______.
A.
B.
C.
D.
45.  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.
46.  The FDA shall provide a written determination ______ after FDA received the IND or earlier.
A.
B.
C.
D.
47.  A protocol is required to contain ________.
A.
B.
C.
D.
48.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
49.  A test article includes all of the following except for _______.
A.
B.
C.
D.
50.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
51.  The father's informed consent need not be secured for the following:
A.
B.
C.
D.
52.  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.
53.  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.
54.  Testing facility management may replace the study director during the conduct of the study.
A.
B.
55.  _______ 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.
56.  DOD stands for _______.
A.
B.
C.
D.
57.  Only the principal investigator is allowed to transcribe data from the document to the CRF.
A.
B.
58.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
59.  An IRB can consist of all members in the same profession.
A.
B.
60.  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.
61.  A waiver request is required to contain at least _______.
A.
B.
C.
D.
62.  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.
63.  The informed consent shall contain a description of ________.
A.
B.
C.
D.
64.  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.
65.  An IEC ensured the protection of the ______ of human subjects in a clinical investigation.
A.
B.
C.
D.
66.  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.
67.  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.
68.  ________ are the two most important design techniques for avoiding bias in a clinical trial.
A.
B.
C.
D.
69.  What date should an investigator write when he failed to sign the consent form on the date of the consent?
A.
B.
C.
70.  IRB stands for _______.
A.
B.
C.
D.
71.  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.
72.  Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.
A.
B.
73.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
74.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
75.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
76.  The Ethical Advisory Board may not have a board member who is a full-time employee of the _____.
A.
B.
C.
D.
77.  Clinical investigation means any experiment that involves a test article and no human subjects.
A.
B.
78.  Comparative effectiveness studies, large simple trials, and pharmacoeconomic studies are classified as _______ study.
A.
B.
C.
D.
79.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
80.  ______ 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.
81.  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.
82.  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.
83.  ________ is not an objective of a human pharmacology study.
A.
B.
C.
D.
84.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
85.  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.
86.  The terms research, clinical research, clinical study, study, and clinical investigation are all synonymous with protocol.
A.
B.
87.  The FDA requires specific elements to be included in an informed consent document.
A.
B.
88.  For a drug expected to be used in children, evaluation should be made in the appropriate age group.
A.
B.
89.  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.
90.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
91.  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.
92.  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.
93.  For a double blind study, ________ are unaware of the treatment assignments.
A.
B.
C.
D.
94.  IND means ______.
A.
B.
C.
D.
95.  For an IRB, there must be at least one member ________.
A.
B.
C.
D.
96.  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.
97.  In reporting adverse events for a trial , you will need to report ________ adverse events.
A.
B.
C.
D.
98.  ________ 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.
99.  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.
100.  The ICH document "General Considerations for Clinical Trials" is intended to present an overview of the ICH clinical safety and efficacy documents?
A.
B.
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