When a short form is used for informed consent the witness must sign the short form or the summary? - ANSWER- False-they must sign both
What is FDA form 3454 - ANSWER- Certification Financial Interests and Arrangements of Clinical Investigators
What are the three main basic ethical principles...
Socra CCRP Exam Questions and
Answers(SCORED A+)
Contract Research Organization - ANSWER- A person or an organization (commercial,
academic, or other) contracted by the sponsor to
perform one or more of a sponsor's trial-related duties and functions.
When a short form is used for informed consent the witness must sign the short form or
the summary? - ANSWER- False-they must sign both
What is FDA form 3454 - ANSWER- Certification Financial Interests and Arrangements
of Clinical Investigators
What are the three main basic ethical principles of the Belmont Report? - ANSWER-
Respect for persons.
Beneficence.
Justice.
Phase III - ANSWER- Study Participants: 300 to 3,000 volunteers who have the disease
or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
Phase I - ANSWER- 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Phase II - ANSWER- Study Participants: Up to several hundred people with the
disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
The main concept of 21 CFR 50 is - ANSWER- protection of human subjects
21 CFR 50 part D - ANSWER- protection of childern
, A____________ 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. - ANSWER- adverse event
The FDA form 483 is used for _______ - ANSWER- Inspectional oberservation
The international ethical and scientific quality standard for designing, conducting,
recording and reporting trials that involve the participation of human subjects is known
as - ANSWER- GCP
A(n) _________ is an investigational or marketed product, or placebo, used as a
reference in a clinical trial. - ANSWER- comparator
What is 21 CFR 50.23 Subpart B? - ANSWER- the exception to the general
requirements
This form is used for the voluntary reporting of adverse events and product problems -
ANSWER- 3500
is permission to examine, analyze, verify, and reproduce any records and reports that
are important to evaluation of a clinical trial - ANSWER- direct access
21 cfr part b - ANSWER- ICF
Belmont Report (1979) - ANSWER- respect for persons, beneficence, justice
significant risk device - ANSWER- s a study of a device that presents a potential for
serious risk to the health, safety, or welfare of a subject and (1) is intended as an
implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial
importance in diagnosing, curing, mitigating
A ________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 -
ANSWER- crf
sae form - ANSWER- 3500a
The sponsor shall notify the FDA by telephone or fax any unexpected fatal or life-
threatening experience associated with the use of the drug as soon as possible but no
later than _____ after the sponsor's initial receipt of the information - ANSWER- 7 days
Unexpected serious suspected adverse reactions and observations from animal studies
suggesting significant risk to human subjects must be reported to FDA as soon as
possible but no later than within __ calendar days following the sponsor's initial receipt
of the information. - ANSWER- 15 days
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