CRA EXAM QUESTIONS WITH
CORRECT SOLUTIONS||100%
GUARANTEED PASS||A+
GRADED||UPDATED 2026/2027
SYLLABUS||<<NEWEST VERSION>>
fundamental research exemption can be voided by - ANSWER ✓ performing
research that is not basic or applied
accepting a restriction form a sponsor on the inclusion of foreign nationals in a
research project
accepting a publication restriction in a research agreement
once an institution submits a proposal to a sponsor in response to an RFP -
ANSWER ✓ proposal constitutes a binding offer on the part of the institution to
conduct the work as proposed
to be protected by copyright work must - ANSWER ✓ be original
include a copyright notice
include a disclaimer
phase III clinical trial - ANSWER ✓ involves randomized and blind testing in
several hundred to several thousand patients to evaluate the risks and benefits of
drug or device
department of energy - ANSWER ✓ oversees the office of science
office of scientific integrity - ANSWER ✓ located within NIH
intergovernmental personnel act - ANSWER ✓ covers the temporary exchange of
employees within federal agencies
simplified method for determining F&A - ANSWER ✓ can be used when the
total direct cost of work does not exceed $10million
, Executive order 12372 - ANSWER ✓ fosters an intergovernmental partnership
and strengthens federalism by relying on state and local processes for the
coordination and review of proposed federal assistance
FDA - ANSWER ✓ part of DHHS
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
Which federal agency is responsible for prosecuting institutional violations of
effort reporting - ANSWER ✓ U.S. Department of Justice, under the False Claims
Act
The National Institutes of Health requires a written description of a program for
providing instruction in the responsible conduct of research for - ANSWER ✓
Institutional National Research Service Awards
What site areas are viewed during a PQV? - ANSWER ✓ Subject room,
monitoring area, pharmacy, storage area, back-up generators, & fax, phone, email,
& Internet access
Name common Central IRBs - ANSWER ✓ WIRB (Western IRB), Schulman,
Quorum, Copernicus
Name local IRBs - ANSWER ✓ Cornell IRB (NY), Emory IRB (GA), St. Jude
IRB(TN)
483 - ANSWER ✓ Letter of non compliance issued by FDA (Food & Drug
Administration)
CORRECT SOLUTIONS||100%
GUARANTEED PASS||A+
GRADED||UPDATED 2026/2027
SYLLABUS||<<NEWEST VERSION>>
fundamental research exemption can be voided by - ANSWER ✓ performing
research that is not basic or applied
accepting a restriction form a sponsor on the inclusion of foreign nationals in a
research project
accepting a publication restriction in a research agreement
once an institution submits a proposal to a sponsor in response to an RFP -
ANSWER ✓ proposal constitutes a binding offer on the part of the institution to
conduct the work as proposed
to be protected by copyright work must - ANSWER ✓ be original
include a copyright notice
include a disclaimer
phase III clinical trial - ANSWER ✓ involves randomized and blind testing in
several hundred to several thousand patients to evaluate the risks and benefits of
drug or device
department of energy - ANSWER ✓ oversees the office of science
office of scientific integrity - ANSWER ✓ located within NIH
intergovernmental personnel act - ANSWER ✓ covers the temporary exchange of
employees within federal agencies
simplified method for determining F&A - ANSWER ✓ can be used when the
total direct cost of work does not exceed $10million
, Executive order 12372 - ANSWER ✓ fosters an intergovernmental partnership
and strengthens federalism by relying on state and local processes for the
coordination and review of proposed federal assistance
FDA - ANSWER ✓ part of DHHS
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
Which federal agency is responsible for prosecuting institutional violations of
effort reporting - ANSWER ✓ U.S. Department of Justice, under the False Claims
Act
The National Institutes of Health requires a written description of a program for
providing instruction in the responsible conduct of research for - ANSWER ✓
Institutional National Research Service Awards
What site areas are viewed during a PQV? - ANSWER ✓ Subject room,
monitoring area, pharmacy, storage area, back-up generators, & fax, phone, email,
& Internet access
Name common Central IRBs - ANSWER ✓ WIRB (Western IRB), Schulman,
Quorum, Copernicus
Name local IRBs - ANSWER ✓ Cornell IRB (NY), Emory IRB (GA), St. Jude
IRB(TN)
483 - ANSWER ✓ Letter of non compliance issued by FDA (Food & Drug
Administration)
