SOCRA CCRP TEST QUESTIONS & ANSWERS
WITH COMPLETE SOLUTIONS GRADED A+
QUESTIONS AND ANSWERS
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
WITH COMPLETE SOLUTIONS GRADED A+
QUESTIONS AND ANSWERS
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
