Other

Question 1

Adverse events

Answer 1

are, by definition, events that cause harm to subjects.

Question 2

Unanticipated problems

Answer 2

are events that increase risk to subjects. [ Risk is not harm; it is the possibility of harm. ]

Question 3

How does Federal Regulation define a human subject ?

also applies to Common Rule

Answer 3

Federal regulations define a human subject as a living individual about whom an investigator conducting research obtains:

(1) Data through intervention or interaction with the individual or
(2) identifiable private information

Reference Page 79

Question 4

How does Federal Regulations define research?

also applies to Common Rule

Answer 4

Federal regulations define “research” as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Reference page 78

Question 5

What are the Sponsor’s responsibilities in FDA-Regulated Research ?

Answer 5

The responsibilities of the research sponsor can be divided into four main areas:

1) qualifying and informing investigators
2) monitoring study conduct
3) completing regulatory filings
4) control of product (drug, biological or device) shipment and disposition