Question

Q1. FDA Form ________ is used for financial disclosure.

	A.	1571
	B.	3412
	C.	3430
	D.	3455

QUESTION 2

Different from a traditional IND, expanded access programs do not require investigators to maintain compliance with the requirements of Part 312 subpart D.

True Or False

QUESTION 3

Which of the following are true statements?

	A.	Expanded access use may begin 30 days after FDA's receipt of the request, NO exceptions
	B.	For emergency access use the FDA must determine that the patient cannot obtain the drug under another IND ( or similar program).
	C.	In order to request expanded access under a treatment IND clinical trials must be either be in progress of have been completed.
	D.	Details on treatment INDs are not noted in Part 312

QUESTION 4

The section of the CFR covering expanded access programs is

	A.	Part 58
	B.	Part 211
	C.	Part 312
	D.	Part 210

QUESTION 5

Investigators must disclose any financial interests with the test article under study (21 CFR part 54) to discourage bias.

True or False

QUESTION 6

Which of the following should be considered when determining if a data monitoring committee is needed?

	A.	toxicity concerns
	B.	fragile patient populations (children for example)
	C.	number of centers where research is being conducted
	D.	All of the above

QUESTION 7

Withholding of data is defined as data that has not been presented 8 months post study completion.

True or False

QUESTION 8

Please select each item that is related to Conflicts of Interest in clinical research.

	A.	FDA Investigator Disclosure Regulations
	B.	Public Health Service regulations for institutions conducting research
	C.	FDA Compliance Policies
	D.	Federal Policy for the Protection of Human Subjects in Research (Common Rule)

QUESTION 9

A 'significan financial interest" might be

	A.	stock options
	B.	copyrights
	C.	payment for services
	D.	All of the above
	E.	A and B only

QUESTION 10

Select expanded access use of regulated products can be approved without a form of IND.

True or False