Contract Research Organization
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 i
...
Contract Research Organization
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?
False-they must sign both
What is FDA form 3454
Certification Financial Interests and Arrangements of Clinical Investigators
What are the three main basic ethical principles of the Belmont Report?
Respect for persons.
Beneficence.
Justice.
Phase III
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
20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Phase II
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
protection of human subjects
21 CFR 50 part D
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.
adverse event
The FDA form 483 is used for _______
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
GCP
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