CRA 2019 Study Guide Exam
2025/2026
Export controls - banned countries - ANSWER Cuba, Crimea, Iran, North Korea, Syria,
Sudan
CPM (critical path method) - ANSWER scheduling project activities; longest overall
duration
AU-C 935 Materiality - ANSWER apply to each major program rather than all the
programs combined
Qui Tam Action - ANSWER under False Claims Act, brings action on behalf of
government, also known as whistleblower
CFR title 45 - ANSWER Public Welfare
45 CFR 46 - ANSWER Common Rule: human subjects
NSDD-189 - ANSWER policy for controlling fundamental research
CFR title 9 - ANSWER animals and animal products
Unsolicited proposal - ANSWER request for applications (RFA)
Proposal with specified due date - ANSWER request for proposals (RFP)
20 USC 1001(a) - ANSWER U.S. Code's general definition for institutions of higher
education
Export - Dept of Commerce - ANSWER Export Administration Regulations (EAR)
EAR99 - ANSWER items and equipment used to conduct fundamental research and not
restricted by U.S. export controls
Export - U.S. Dept of State - ANSWER International Traffic in Arms Regulations (ITAR)
ITAR - ANSWER munitions list: licenses always required, focus on potential military
applications
EAR - ANSWER commerce control list: dual use-having both legitimate commercial
purpose and potential military application
Clinical trial - ANSWER A research study in which one or more human subjects are
prospectively assigned to one or more interventions (which may include placebo or
,other control) to evaluate the effects of those interventions on health-related biomedical
or behavioral outcomes.
Human subject - ANSWER A living individual about whom an investigator (whether
professional or student) conducting research obtains (1) data through intervention or
interaction with the individual, or(2) identifiable private information.
Solomon Amendment - ANSWER deny federal grants to institutions of higher education if
they prohibit or prevent ROTC or military recruitment on campus (1996)
Stevens Amendment - ANSWER give the federal government public credit for federally
funded programs and projects (give credit where credit is due)
Bayh-Dole Act (37 CFR 401) - ANSWER a uniform patent policy among the many federal
agencies that fund research, enabling small businesses and non-profit organizations,
including universities, to retain title to inventions made under federally-funded research
programs (1980)
Davis-Bacon Act - ANSWER establishes the requirement for paying the local prevailing
wages on public works projects for laborers and mechanics (1931)
Grants - ANSWER provides assistance; generally little involvement from sponsor,
includes general T&C
Cooperative Agreement - ANSWER provides assistance; substantial programmatic
involvement in project described in specific terms
Contracts - ANSWER acquisition mechanism for goods and services, direct benefit to
the government, usually government-initiated
NIH Other Transactions - ANSWER new; used when greater flexibility is needed for
agency and applicant, no clear allowable/unallowable, non-traditional partners, CFRs do
not apply
SF269 - ANSWER financial status report
SF271 - ANSWER reimbursement for construction programs
SF502 - ANSWER medical record
SF272 - ANSWER federal cash transaction report for expenditures
SF428 - ANSWER tangible property report
STTR - ANSWER research institution
SBIR - ANSWER private, for-profit
Small business contracting plan - ANSWER over $700k, for supplies, travel and
equipment
, Automated Standard Application for Payments (ASAP) - ANSWER electronic payment
application for federal agencies to quickly and securely disburse funds to recipient
organizations
Cost Accounting Standards Board (CASB) - ANSWER a U.S. federal government body
with a mandate of promoting consistency and uniformity in cost accounting activities
involving government grants and contracts; 19 standards
Phase I Clinical Trial - ANSWER assess the safety of a drug or device, several months to
complete, usually small number of healthy volunteers (20 to 100)
Phase II Clinical Trial - ANSWER test the efficacy of a drug or device, can last from
several months to two years, involves up to several hundred patients
Phase III Clinical Trial - ANSWER test the efficacy of a drug or device (second phase of
testing), can last from several months to two years, involves up to several hundred
patients
Phase IV Clinical Trial - ANSWER conducted after a drug or device has been approved
for consumer sale. Pharmaceutical companies have several objectives at this stage: (1)
to compare a drug with other drugs already in the market; (2) to monitor a drug's
long-term effectiveness and impact on a patient's quality of life; and (3) to determine the
cost-effectiveness of a drug therapy relative to other traditional and new therapies. can
result in a drug or device being taken off the market or restrictions of use could be
placed on the product depending on the findings in the study.
Shelby Amendment - ANSWER allowing members of the public to gain access to specific
research data that has resulted from federally sponsored research projects (1998)
CFDA - ANSWER government-wide compendium of Federal programs, projects,
services, and activities that provide assistance or benefits to the American public
Yellow Book - ANSWER outlines the requirements for audit reports, professional
qualifications for auditors, and audit organization quality control. Auditors of federal,
state, and local government programs use these standards to perform their audits and
produce their reports.
Public Law 89-544 - ANSWER Animal Welfare Act 1966; the only Federal law in the
United States that regulates the treatment of animals in research, exhibition, transport,
and by dealers; the minimum acceptable standard
CFR title 48 - ANSWER Federal acquisition (government procurement)
CFR title 46 - ANSWER Coast Guard, Dept of Homeland Security (shipping)
CFR title 47 - ANSWER Telecommunications (FCC)
CFR title 49 - ANSWER transportation (hazardous materials)
2025/2026
Export controls - banned countries - ANSWER Cuba, Crimea, Iran, North Korea, Syria,
Sudan
CPM (critical path method) - ANSWER scheduling project activities; longest overall
duration
AU-C 935 Materiality - ANSWER apply to each major program rather than all the
programs combined
Qui Tam Action - ANSWER under False Claims Act, brings action on behalf of
government, also known as whistleblower
CFR title 45 - ANSWER Public Welfare
45 CFR 46 - ANSWER Common Rule: human subjects
NSDD-189 - ANSWER policy for controlling fundamental research
CFR title 9 - ANSWER animals and animal products
Unsolicited proposal - ANSWER request for applications (RFA)
Proposal with specified due date - ANSWER request for proposals (RFP)
20 USC 1001(a) - ANSWER U.S. Code's general definition for institutions of higher
education
Export - Dept of Commerce - ANSWER Export Administration Regulations (EAR)
EAR99 - ANSWER items and equipment used to conduct fundamental research and not
restricted by U.S. export controls
Export - U.S. Dept of State - ANSWER International Traffic in Arms Regulations (ITAR)
ITAR - ANSWER munitions list: licenses always required, focus on potential military
applications
EAR - ANSWER commerce control list: dual use-having both legitimate commercial
purpose and potential military application
Clinical trial - ANSWER A research study in which one or more human subjects are
prospectively assigned to one or more interventions (which may include placebo or
,other control) to evaluate the effects of those interventions on health-related biomedical
or behavioral outcomes.
Human subject - ANSWER A living individual about whom an investigator (whether
professional or student) conducting research obtains (1) data through intervention or
interaction with the individual, or(2) identifiable private information.
Solomon Amendment - ANSWER deny federal grants to institutions of higher education if
they prohibit or prevent ROTC or military recruitment on campus (1996)
Stevens Amendment - ANSWER give the federal government public credit for federally
funded programs and projects (give credit where credit is due)
Bayh-Dole Act (37 CFR 401) - ANSWER a uniform patent policy among the many federal
agencies that fund research, enabling small businesses and non-profit organizations,
including universities, to retain title to inventions made under federally-funded research
programs (1980)
Davis-Bacon Act - ANSWER establishes the requirement for paying the local prevailing
wages on public works projects for laborers and mechanics (1931)
Grants - ANSWER provides assistance; generally little involvement from sponsor,
includes general T&C
Cooperative Agreement - ANSWER provides assistance; substantial programmatic
involvement in project described in specific terms
Contracts - ANSWER acquisition mechanism for goods and services, direct benefit to
the government, usually government-initiated
NIH Other Transactions - ANSWER new; used when greater flexibility is needed for
agency and applicant, no clear allowable/unallowable, non-traditional partners, CFRs do
not apply
SF269 - ANSWER financial status report
SF271 - ANSWER reimbursement for construction programs
SF502 - ANSWER medical record
SF272 - ANSWER federal cash transaction report for expenditures
SF428 - ANSWER tangible property report
STTR - ANSWER research institution
SBIR - ANSWER private, for-profit
Small business contracting plan - ANSWER over $700k, for supplies, travel and
equipment
, Automated Standard Application for Payments (ASAP) - ANSWER electronic payment
application for federal agencies to quickly and securely disburse funds to recipient
organizations
Cost Accounting Standards Board (CASB) - ANSWER a U.S. federal government body
with a mandate of promoting consistency and uniformity in cost accounting activities
involving government grants and contracts; 19 standards
Phase I Clinical Trial - ANSWER assess the safety of a drug or device, several months to
complete, usually small number of healthy volunteers (20 to 100)
Phase II Clinical Trial - ANSWER test the efficacy of a drug or device, can last from
several months to two years, involves up to several hundred patients
Phase III Clinical Trial - ANSWER test the efficacy of a drug or device (second phase of
testing), can last from several months to two years, involves up to several hundred
patients
Phase IV Clinical Trial - ANSWER conducted after a drug or device has been approved
for consumer sale. Pharmaceutical companies have several objectives at this stage: (1)
to compare a drug with other drugs already in the market; (2) to monitor a drug's
long-term effectiveness and impact on a patient's quality of life; and (3) to determine the
cost-effectiveness of a drug therapy relative to other traditional and new therapies. can
result in a drug or device being taken off the market or restrictions of use could be
placed on the product depending on the findings in the study.
Shelby Amendment - ANSWER allowing members of the public to gain access to specific
research data that has resulted from federally sponsored research projects (1998)
CFDA - ANSWER government-wide compendium of Federal programs, projects,
services, and activities that provide assistance or benefits to the American public
Yellow Book - ANSWER outlines the requirements for audit reports, professional
qualifications for auditors, and audit organization quality control. Auditors of federal,
state, and local government programs use these standards to perform their audits and
produce their reports.
Public Law 89-544 - ANSWER Animal Welfare Act 1966; the only Federal law in the
United States that regulates the treatment of animals in research, exhibition, transport,
and by dealers; the minimum acceptable standard
CFR title 48 - ANSWER Federal acquisition (government procurement)
CFR title 46 - ANSWER Coast Guard, Dept of Homeland Security (shipping)
CFR title 47 - ANSWER Telecommunications (FCC)
CFR title 49 - ANSWER transportation (hazardous materials)
