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 ✔ -
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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
