SOCRA CCRP Exam Flashcards| 62 QUESTIONS|
100% CORRECT 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
100% CORRECT 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
