Socra Practice Test

180 Questions  I  By Lucyb122 on November 2, 2011
Practice test for SOCRA exam certification

  

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1.  Grounds for imposition of clinical hold include the following:
A.
B.
C.
D.
2.  Study _____ means the date the protocol is signed by the _____.
A.
B.
C.
D.
3.  The immediate package of an investigational new drug intended for human use shall bear a label with the statement
A.
B.
C.
D.
4.  _____ 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.
5.  Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.
A.
B.
C.
D.
6.  ______ means any person or organization element, except the study director, designated by the testing facililty management to perform the duties relating to quality assurance of nonclinical laboratory study.
A.
B.
C.
D.
7.  Dose-response studies and studies using an active control drug, as well as placebo, are strongly encouraged.
A.
B.
8.  When determining whether children are capable of providing assent, the IRB must take into account ______.
A.
B.
C.
D.
9.  The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.
A.
B.
C.
D.
10.  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.
11.  An investigation may only resume after the FDA has notified the sponsor that the investigation may proceed.
A.
B.
12.  ______ studies usually include from several hundred to several thousand subjects.
A.
B.
C.
D.
13.  A sponsor shall submit a protocol amendment describing any change in a _____ protocol that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study.
A.
B.
C.
D.
14.  An IND goes into effect _____ after the FDA receives the IND, unless the FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold.
A.
B.
C.
D.
15.  The sponsor's request for a regulatory hearing must be made within _____ of the sponsor's receipt of the FDA's notification of non-acceptance.
A.
B.
C.
D.
16.  The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.
A.
B.
C.
D.
17.  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.
18.  The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review process when necessary to protect the rights or welfare of subjects.
A.
B.
19.  Disability is a non-substantial disruption of a person's ability to conduct normal life functions.
A.
B.
20.  For a Phase 2 study, which of the following statements is not correct:
A.
B.
C.
D.
21.  Sponsor means a person who does not initiate a clinical investigation.
A.
B.
22.  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.
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23.  A subject may only be in normal health.
A.
B.
24.  The existence of an investigational new drug application will not be disclosed by the FDA unless it has previously been publicly disclosed or aknowledged.
A.
B.
25.  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.
26.  _____ must be obtained by each investigator from each subject participating in an investigation of the device, unless documentation is waived by an IRB.
A.
B.
C.
D.
27.  At any time during the course of the investigation, the FDA may communicate with the sponsor about _____.
A.
B.
C.
D.
28.  A person who initiates and supports, by provision of financial or other resources, a nonclinical study is the ______.
A.
B.
C.
D.
29.  Prior to submission of the initial IND, the sponsor may request a pre-investigational new drug meeting.
A.
B.
30.  DOD stands for _______.
A.
B.
C.
D.
31.  The FDA may place a proposed or ongoing Phase 2 or 3 investigation on clinical hold if it finds that the protocol is clearly deficient in design to meet the stated objectives.
A.
B.
32.  Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.
A.
B.
33.  A representative of the _____ shall have access to the written procedures established for the inspection.
A.
B.
C.
D.
34.  An unapproved IDE permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.
A.
B.
35.  The following categories of investigations are considered to have approved applications for IDE's, unless the FDA has notified a sponsor that approval of an application is required:
A.
B.
C.
D.
36.  The FDA shall provide a written determination ______ after the FDA receives the IND or earlier.  
A.
B.
C.
D.
37.  If an IND is terminated, the sponsor shall _____.
A.
B.
C.
D.
38.  The formal evaluation of the quantitive evidence from two or more trials bearing the same questions is known as a _____.
A.
B.
C.
D.
39.  A statement that participation is voluntary is a ________.
A.
B.
C.
D.
40.  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.
41.  The patient population studied with a new antihypertensive drug should be include a broad range of patients with _____.
A.
B.
C.
D.
42.  ______ means a person who actually conducts a nonclinical laboratory study.
A.
B.
C.
D.
43.  Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.  
A.
B.
C.
D.
44.  The primary basis of assessment of efficacy of antihypertensive drugs is the effect of the drug on _____ pressure.
A.
B.
C.
D.
45.  When a rating scale is used as a primary variable, it is important to address the following factors:
A.
B.
C.
D.
46.  GCP does not required informed consent in life-threatening situations when the IEC reviewing the study finds, before the initiation of the study, that informed consent is not feasible.
A.
B.
47.  The primary endpoint should be the variable capable of providing the most clinically relevant and convincing evidence
A.
B.
48.  The contract research organization shall select a monitor that is _____.
A.
B.
C.
D.
49.  The safety and efficacy of combinations can also be assessed by examining the effect of the combination in patients failing to respond to both of  the single drugs.
A.
B.
50.  CFR stands for ______.  
A.
B.
C.
D.
51.  In general, protocols for ______ studies may be less detailed and more flexible.
A.
B.
C.
D.
52.  A sponsor is not required to submit an annual report to an IND on inactive status.
A.
B.
53.  As soon as possible, and no more than _____ after the imposition of the clinical hold, the Division Director will provide the sponsor with a written explanation on the basis for the hold.
A.
B.
C.
D.
54.  The FDA may propose to terminate an IND during Phase 2 or Phase 3 if the FDA finds _____.
A.
B.
C.
D.
55.  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.
56.  A sponsor may transfer resonsibility for any or all of the obligations to a _____.
A.
B.
C.
D.
57.  The term "person" includes all of the following except ______.
A.
B.
C.
D.
58.  ________ means an individual who actually conducts a clinical investigation.
A.
B.
C.
D.
59.  _____ means a device subject to section 520(I) of the act, that is, a device that the FDA considered to be a new drug or an antibiotic drug before May 28, 1976.
A.
B.
C.
D.
60.  Specimen means any material derived from a test system for examination or analysis.
A.
B.
61.  IRB approval means the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an insitution within the constraints set forth by the IRB and by other institutional and Federal requirements.
A.
B.
62.  A sponsor of a clinical study of a marketed drug is not required to make a safety report for any adverse experience associated with the use of the drug that is not from the clinical study itself.
A.
B.
63.  GCP stands for _____.
A.
B.
C.
D.
64.  A brief summary of the status of each study in progess and each study completed in the previous year is known as _____.
A.
B.
C.
D.
65.  Phase 1 studies may be conducted in ______.
A.
B.
C.
D.
66.  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.
67.  A sponsor shall have ______ of the anniversary date that the IND went into effect to submit a brief report of the investigation's progress. 
A.
B.
C.
D.
68.  A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.
A.
B.
69.  Subpart D of 21 CFR 50 lists the 
A.
B.
C.
D.
70.  Permission means the agreement of _______ to the participation of their child or ward in a clinical investigation.
A.
B.
C.
D.
71.  Misbranding is identified in _____ of the Federal Food, Drug, and Cosmetic Act.
A.
B.
C.
D.
72.  Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of less than 30 days.
A.
B.
73.  No individual clinical trial can be expected to be totally representative of futures uses because of the possible influences of ______.
A.
B.
C.
D.
74.  Disclosure - Fianancial Interests and Arrangements of Clinical Investigators
A.
B.
C.
D.
75.  The contract research organization assumes all of the following for a sponsor except for ______.
A.
B.
C.
D.
76.  A test article includes all of the following except for _______.
A.
B.
C.
D.
77.  Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
A.
B.
78.  The certification shall describe the drug that is to be exported, identify the country or countries to which the drug is to be exported, and affirm that the _____.
A.
B.
C.
D.
79.  An investigational new drug may be exported from the United States for use in a clinical investigation under any of the following conditions:
A.
B.
C.
D.
80.  If the testing facility refuses an inspection, the FDA will not consider a nonclinical laboratory study in support of an application for a research or marketing permit.
A.
B.
81.  The sponsor shall monitor investigations to indentify when an IRB determines that it cannot approve the research because it does not meet the criteria for exception or because of other relevant ethical concerns.
A.
B.
82.  A _____ trial has the primary objective of showing that the response to the investigational product is superior to a comparative agent.
A.
B.
C.
D.
83.  In combination with blinding, _____ helps avoid possible bias in the selection and allocation of subjects arising from the predictability of treatment assignments.
A.
B.
C.
D.
84.  The FDA may propose to terminate an IND during Phase 1 if it finds _____.
A.
B.
C.
D.
85.  What is FDA form 1571?
A.
B.
C.
D.
86.  If the short form method is utilized, the witness shall sign _______.
A.
B.
C.
D.
87.  An IND may be submitted for one or more phases of an investigation.
A.
B.
88.  IDE stand for _____.
A.
B.
C.
D.
89.  Condition of blood pressure measurement should be well described and standarized with respect to the _____.
A.
B.
C.
D.
90.  The Belmont report consists of three main priciple: benefice, respect for person, and _______
91.  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.
92.  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.
93.  The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _____ following the study's completion.
A.
B.
C.
D.
94.  If the sponsor disagrees with the reasons cited for the clinical hold, the sponsor may request a/an ______.
A.
B.
C.
D.
95.  The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.
A.
B.
96.  Parent means a child's biological parent, but it does not refer to an adoptive parent.
A.
B.
97.  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.
98.  FDA stands for the ________.
A.
B.
C.
D.
99.  Investigational new drug means a _______ that is used in a clinical investigation.  
A.
B.
C.
D.
100.  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.
101.  The secondary endpoint of studies to assess antihypertensive effect is the absolute change at the end of the dosing interval from the drug-free baseline blood pressure compared to the change in the control group.
A.
B.
102.  Blinding is intended to limit the occurrence of ______ bias in the conduct and interpretation of a clinical trial.
A.
B.
C.
D.
103.  The documentation required after using a test article shall be submitted to the IRB within _____ working days.
A.
B.
C.
D.
104.  In general, patients with target organ damage secondary to hypertension should not be included in _____ trials of more than very brief duration.
A.
B.
C.
D.
105.  A waiver request is required to contain at least _______.
A.
B.
C.
D.