Socra Practice Exam

62 Questions  I  By Bseko

  
Changes are done, please start the quiz.


Question Excerpt

Removing question excerpt is a premium feature

Upgrade and get a lot more done!
1.  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.
2.  A significant risk device....
A.
B.
C.
3.  The "Doctor's Trial" prompted the Bellmont Report.
A.
B.
4.  The FDA form 483 is used for ...
5.  What is the FDA form 482 for?
A.
B.
C.
D.
6.  What is the FDA form 3455?
A.
B.
C.
D.
7.  21CFR56 is IRB Functions and Operations
A.
B.
8.  What is 21CFR50.50 Subpart D?
A.
B.
C.
D.
9.  What is 21CFR50.52 Subpart D?
A.
B.
C.
10.  When a short form is used for Informed Consent, the witness must sign either the short form or the summary.
A.
B.
11.  The object of GCP is part of the ICH mission statement.
A.
B.
12.  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. 
13.  What do the HHS stand for?
14.  What is 45CFR46 Subpart A?
A.
B.
C.
D.
15.  What is 45CFR46 Subpart B?
A.
B.
C.
D.
16.  The Code of Federal Regulations that applies to Investigational New Drug Applications is..
A.
B.
C.
D.
17.  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.
18.  Which of the following is 21CFR56.106 Subpart B?
A.
B.
C.
19.  The form _____________ is used for investigational new drugs (or IND).
20.  ________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
21.  What is 45CFR46?
A.
B.
C.
D.
22.  Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the...
A.
B.
C.
D.
23.  What is the federal department responsible for helping people of Canada maintain and improve their health?
A.
B.
C.
D.
24.  What is 21CFR50 Subpart D?
A.
B.
C.
D.
25.  What is 21CFR50.51 Subpart D?
A.
B.
C.
D.
E.
26.  This form is used for the mandatory reporting of serious adverse events
27.  What is 21CFR50.25 Subpart B?
A.
B.
C.
D.
28.  What is 21CFR50.54 Subpart D?
A.
B.
C.
D.
29.  What is 21CFR50 Subpart B?
A.
B.
C.
D.
30.  What is 21CFR50.53 Subpart D?
A.
B.
C.
D.
31.  A(n) _______________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial.
32.  What is 45CFR46 Subpart C?
A.
B.
C.
D.
33.  Who monitors the progress of all clinical trial investigations being conducted under its IND?
A.
B.
C.
D.
34.  The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..
A.
B.
C.
D.
35.  The Code of Federal Regulations that applies to the Protection of Human Subjects is..
A.
B.
C.
D.
36.  Under 21CFR312, this form is the statement of the investigator of a clinical trial
A.
B.
C.
D.
37.  What is 21CFR50.20 Subpart B?
A.
B.
C.
D.
38.  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.
39.  The World Medical Association (WMA) ethical principals for medical research involving human subjects is called....
A.
B.
C.
D.
40.  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.
41.  What does 21CFR54 deal with?
A.
B.
C.
D.
42.  What is the FDA form 3454?
A.
B.
C.
D.
43.  Which of the following are necessary to satisy 21CFR50.24 Subpart B?
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
44.  21CFR56.107 Subpart B is IRB Membership.
A.
B.
45.  What is the minimum number of IRB members?
A.
B.
C.
D.
46.  What is 21CFR56.109 Subpart C?
A.
B.
C.
D.
47.  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.
48.  This form is used for the voluntary reporting of adverse events and product problems
49.  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.
50.  Which of the following are necessary to satisfy 21CFR50.23 Subpart B?
A.
B.
C.
D.
E.
F.
G.
H.
I.
51.  What is 21CFR50.24 subpart B?
A.
B.
C.
D.
52.  What is 21CFR50.55 Subpart D?
A.
B.
C.
D.
53.  21CFR56 Subpart B is IRB Documentation.
A.
B.
54.  What are the three fundamental ethical principals for human subjects research?
A.
B.
C.
D.
E.
F.
G.
H.
55.  What is 21CFR50.23 Subpart B?
A.
B.
C.
D.
56.  The Code of Federal Regulations that applies to Institutional Review Boards is..
A.
B.
C.
D.
57.  What is 21CFR50.56 Subpart D?
A.
B.
C.
D.
58.  What is 21CFR50.27 Subpart B?
A.
B.
C.
D.
59.  Which of the following is IRB Functions and Regulations?
A.
B.
C.
D.
60.  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 __________________.
61.  What is 21CFR56.110 Subpart C?
A.
B.
C.
D.
62.  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.
Back to top


to post comments.

Removing ad is a premium feature

Upgrade and get a lot more done!
Take Another Quiz