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Which phase of a clinical trial involves testing the efficacy of a
drug or device? -
ANSWER-
Phase II
The common rule is found at - ANSWER-Section 45 CFR part 46
Subpart A
In a PI initiated clinical trial, the sponsor according to the FDA
is - ANSWER-
The PI submitting the IND to
the FDA
Which of the following expenses would be include in the
distribution base of
modified total direct costs? - ANSWER-equipment
depreciation
,Who owns the following copyrightable works: an online
course on intellectual
property developed by University staff? - ANSWER-
The University
A study subject may have more than one informed
consent/authorization
document for the Study due to - ANSWER-Study
amendment
Under which of the following conditions is a Certificate of
Current Cost and
Pricing required? - ANSWER-From any institution that
received more than
$500,000 in federal
funding
The primary agency having scope over clinical trials is the -
ANSWER-DHHS
Which phase of a clinical trial involves assessing the safety of a
drug or device?
- ANSWER-
Phase I
State and local governments are subject to which of the
following OMB
Circulars? - ANSWER-
A-102
, The first two digits of the CFDA number represent the: -
ANSWER-Sponsor
Mrs. I. M. Hurt is participating in a hypertension study and is
injured. When would it be contractually appropriate for the
sponsor to pay for Mrs. Hurt's injuries - ANSWER-If Mrs. Hurt
was injured by the study drug
Which of the following OMB Circulars addresses the cost
principles for state,
local, and Indian
tribal
Governments? -
ANSWER-A-87
iEdison helps people comply with the requirements of -
ANSWER-Bayh-Dole
Act
The ____ clause in an agreement contemplates the transfer of
agreement rights
from one party, who is an existing party to the agreement, to
another party, who
is not an existing party to the agreement: - ANSWER-
Assignment