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SOCRA Practice Exam

62 Questions  I  By Bseko
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1.  What is the FDA form 482 for?
A.
B.
C.
D.
2.  What is 21CFR50.20 Subpart B?
A.
B.
C.
D.
3.  Which of the following are considered BASIC elements of informed consent under section 21CFR50.25 Subpart B?
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
4.  Which of the following is IRB Functions and Regulations?
A.
B.
C.
D.
5.  What do the HHS stand for?
6.  What is 21CFR50 Subpart B?
A.
B.
C.
D.
7.  What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?
A.
B.
C.
D.
8.  What is 45CFR46 Subpart C?
A.
B.
C.
D.
9.  This form is used for the mandatory reporting of serious adverse events
10.  What is 21CFR50.53 Subpart D?
A.
B.
C.
D.
11.  What is the minimum number of IRB members?
A.
B.
C.
D.
12.  Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the...
A.
B.
C.
D.
13.  When a short form is used for Informed Consent, the patient signs the short form ONLY and the recieves a copy of both the summary and the short form.
A.
B.
14.  What is 21CFR50.25 Subpart B?
A.
B.
C.
D.
15.  Which of the following are necessary to satisy 21CFR50.24 Subpart B?
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
16.  21CFR56.107 Subpart B is IRB Membership.
A.
B.
17.  The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..
A.
B.
C.
D.
18.  What is 21CFR50.24 subpart B?
A.
B.
C.
D.
19.  The World Medical Association (WMA) ethical principals for medical research involving human subjects is called....
A.
B.
C.
D.
20.  What is 21CFR50.50 Subpart D?
A.
B.
C.
D.
21.  The FDA form 483 is used for ...
22.  A(n) _______________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial.
23.  What does 21CFR54 deal with?
A.
B.
C.
D.
24.  What is 21CFR50.52 Subpart D?
A.
B.
C.
25.  Who monitors the progress of all clinical trial investigations being conducted under its IND?
A.
B.
C.
D.
26.  What is 45CFR46?
A.
B.
C.
D.
27.  21CFR56 Subpart B is IRB Documentation.
A.
B.
28.  ________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
29.  What are the three fundamental ethical principals for human subjects research?
A.
B.
C.
D.
E.
F.
G.
H.
30.  What is 45CFR46 Subpart A?
A.
B.
C.
D.
31.  A(n) _______________ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
32.  What is 21CFR56.109 Subpart C?
A.
B.
C.
D.
33.  What is 21CFR50.51 Subpart D?
A.
B.
C.
D.
E.
34.  The object of GCP is part of the ICH mission statement.
A.
B.
35.  What is the FDA form 3455?
A.
B.
C.
D.
36.  What is 21CFR50 Subpart D?
A.
B.
C.
D.
37.  In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapuyetic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered __________________.
38.  What is 21CFR50.56 Subpart D?
A.
B.
C.
D.
39.  What is the FDA form 3454?
A.
B.
C.
D.
40.  The "Doctor's Trial" prompted the Bellmont Report.
A.
B.
41.  The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
A.
B.
42.  The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as...
A.
B.
C.
D.
43.  What is 21CFR50.54 Subpart D?
A.
B.
C.
D.
44.  A significant risk device....
A.
B.
C.
45.  What is 45CFR46 Subpart B?
A.
B.
C.
D.
46.  What is 21CFR50.55 Subpart D?
A.
B.
C.
D.
47.  The Code of Federal Regulations that applies to the Protection of Human Subjects is..
A.
B.
C.
D.
48.  What is the federal department responsible for helping people of Canada maintain and improve their health?
A.
B.
C.
D.
49.  Under 21CFR312, this form is the statement of the investigator of a clinical trial
A.
B.
C.
D.
50.  This form is used for the voluntary reporting of adverse events and product problems
51.  What is 21CFR56.110 Subpart C?
A.
B.
C.
D.
52.  21CFR56 is IRB Functions and Operations
A.
B.
53.  What is 21CFR50.23 Subpart B?
A.
B.
C.
D.
54.  The IRB may, for some or all subjects, waive the requirement hat the subject, or the subject's legally authroized representative, sign a written consent form if it finds that the research presents more than minimal risk of harm to subjects and involves no procedures for which written consent is normall required outside the research context.
A.
B.
55.  What is 21CFR50.27 Subpart B?
A.
B.
C.
D.
56.  A(n) ___________________ can be any unfavorable and unintended sign )including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. 
57.  When a short form is used for Informed Consent, the witness must sign either the short form or the summary.
A.
B.
58.  Which of the following is 21CFR56.106 Subpart B?
A.
B.
C.
59.  Which of the following are necessary to satisfy 21CFR50.23 Subpart B?
A.
B.
C.
D.
E.
F.
G.
H.
I.
60.  The form _____________ is used for investigational new drugs (or IND).
61.  The Code of Federal Regulations that applies to Institutional Review Boards is..
A.
B.
C.
D.
62.  The Code of Federal Regulations that applies to Investigational New Drug Applications is..
A.
B.
C.
D.
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