CERTIFIED RESEARCH ADMINISTRATORS (CRA) EXAM
FALL 2026 WITH ALL CORRECT & 100% VERIFIED
ANSWERS|ALREADY GRADED A+
FAIN ✔Correct Answer-Federal Award Identification Number
IHE ✔Correct Answer-Institution of Higher Education
COSO ✔Correct Answer-Committee of Sponsoring Organizations of the Treadway Commission -
1985
2013 Internal Controls Framework to combat corporate fraud
EUI ✔Correct Answer-Energy Usage Index
FAC ✔Correct Answer-Federal Audit Clearinghouse
FAPIIS ✔Correct Answer-Federal Awardee Performance Integrity and Information System
GOCO ✔Correct Answer-Government owned, Contractor operated
IBS ✔Correct Answer-Institutional Base Salary
PII ✔Correct Answer-Personally Identifiable Information
PRHP ✔Correct Answer-Post-retirement Health Plans
PTE ✔Correct Answer-pass-through entity
REUI ✔Correct Answer-Relative Energy Usage Index
SPOC ✔Correct Answer-Single Point of Contact
TFM ✔Correct Answer-Treasury Financial Manual
The TFM is the Department of the Treasury's official publication of policies, procedures, and
instructions concerning financial management in the Federal Government.
VAT ✔Correct Answer-Value Added Tax
ITAR ✔Correct Answer-International Trafficking in Arms Regulations (22 CFR 120-130) US State
Department, Directorate of Defense Trade Controls (DDTC), defense articles/tech/data, services on
US Munitions List, primarily military, space, and intelligence application, no sharing with non-US
persons AT ALL
EAR ✔Correct Answer-Export Administration Regulations (15 CFR 300-799), US Department of
Commerce, Bureau of Industry and Security (BIS), commodities, software, and technology on the
Commerce Control List, primarily commercial/civilian, sliding scale, exports may occur after a
licensing evaluation
,NRC & DOE ✔Correct Answer-Nuclear Regulatory Commission (NRC) (10 CFR 110) & US
Department of Energy (DOE) (10 CFR 810) · Nuclear reactors, fuel, sensitive nuclear technologies, etc.
FACR ✔Correct Answer-Foreign Asset Control Regulations (31 CFR 500-599), US Department of
Treasury, Office of Foreign Asset Control (OFAC), Sanctioned transactions for good and services
involving: comprehensively sanctioned countries: Cuba, Syria, North Korea, Iran, Individuals or
organizations on US Government Restricted Party List
What prevents violations? ✔Correct Answer-Restricted Party Screening!
Regulatory Exclusions related to exports and sanctions (cover most IHEs) ✔Correct Answer-1.
Public Domain, 2. Educational Information, 3. Fundamental Research
U.S. laws and regulations that regulate and restrict the release of critical items, technologies and
services to foreign nationals, within and outside of the United States, and foreign countries for
reasons of foreign policy and national security. ✔Correct Answer-Export Controls
programs are administered and enforced by the Office of Foreign Asset Control (OFAC) and utilize the
blocking of assets and trade restrictions to accomplish foreign policy and national security goals.
Prohibited transactions are trade or financial transactions and other dealings in which U.S. persons
may not engage unless authorized by OFAC or expressly exempted by statute. U.S. persons must
comply with OFAC regulations, including all U.S. citizens and permanent resident aliens regardless of
where they are located, all persons and entities within the United States, all U.S. incorporated
entities and their foreign branches. ✔Correct Answer-Sanctions
Exports ✔Correct Answer-· Physical Exports (outside US borders)
· Deemed Exports (inside the US)
US Persons ✔Correct Answer-· US Citizens
· Lawful Permanent Residents (Green Card Holders)
· Protected political status (asylee, refugee, amnesty)
· US Companies (incorporated to do business in US)
Fundamental Research ✔Correct Answer-A systematic investigation, including research
development, testing and evaluation designed to develop or contribute to generalizable knowledge
Clinical Research ✔Correct Answer-Broad: study of health and illness in people, Narrow: study of a
product in the body - effects and absorption/distribution
Clinical Trial ✔Correct Answer-(each institution has its own definition but similar key elements) - A
research project to test safety and efficacy of a drug, device, or other treatment; must develop or
contribute to generalizable knowledge. KEY: administering an intervention
Four Phases ✔Correct Answer-Number of phases in a Clinical Trial
Clinical Trial Protocol ✔Correct Answer-1. establishes the primary outcome, 2. Establishes patient
inclusion/exclusion criteria, 3. determines feasibility and budget, 4. verifies how data will be
collected and managed
3 Main Types of Clinical Trials Research ✔Correct Answer-1. Patient-oriented research, 2.
Epidemiological and behavioral studies, 3. Outcomes and health services research
,Pre-Clinical Phase ✔Correct Answer-1. Protocol development, 2. animal testing, 3. funding
applications, 4. IRB approvals
Phase I (Clinical Trial) ✔Correct Answer-Testing of new treatment on a small group of HEALTHY
subjects to determine dosage and side effects. Key Characteristics - 1. ~20-80 HEALTHY volunteers,
determine safety of drug in humans, determine basic (baseline) information of impact on humans.
Phase II Clinical Trial ✔Correct Answer-New treatment expanded to larger group of AFFLICTED
subjects with targeted disease/condition. Key characteristics - 1. subjects randomized (RCT), 2. Adds
a blinded control group (placebo), 3. ~100-300 patients with disease or condition, 4. Go/no-go point
(lowest point of success rate)
Phase III Clinical Trial ✔Correct Answer-Study expanded and new treatment given to large group of
afflicted subjects, usually at multiple sites. Key characteristics - 1. Usually double-blinded (both
providers and patients), 2. Confirms efficacy and safety
3., ~1,000 - 3,000 patient volunteers
After Phase III before Phase IV of Clinical Trial ✔Correct Answer-Apply for FDA approval
Phase IV Clinical Trial ✔Correct Answer-Studies long-term effectiveness, comparing new treatment
to standard treatment. Obtain additional information about risks, benefits, and optimal use. Key
characteristics - 1. intervention is already approved, 2. post-marketing/evaluating intervention use in
public, 3. refine dosage and side effects
CRF ✔Correct Answer-Clinical Trial Case Report Form
Case report forms contain data obtained during the patient's participation in the clinical trial. Before
being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing
the patient's name, medical record number, etc., and giving the patient a unique study number.
CRO ✔Correct Answer-Clinical Trial Contract Research Organization - "translates" between sponsor
and clinical trial site
ICF ✔Correct Answer-Informed Consent Form - a process, not just a signed form
Discussion - Review - Concerns - Time - Signatures
Essential Elements of Informed Consent ✔Correct Answer-1. Research description, 2. Risk, 3,
Benefits, 4. Alternatives, 5. Confidentiality, 6. Compensation, 7. Contacts, 8. Voluntary participation
or withdrawal
IND ✔Correct Answer-Clinical Trial - Investigational New Drug
Process for "sponsor" to obtain FDA approval to use an investigational new drug.
Investigator IND ✔Correct Answer-submitted by physician who initiates & conducts the study
Emergency IND ✔Correct Answer-Allows the FDA to authorize use of experimental drug in
emergency situation
Treatment IND ✔Correct Answer-Submitted for experimental new drugs showing promise in
clinical testing for serious or immediately threatening conditions
, Clinical Trial "Sponsor" ✔Correct Answer-Not necessarily the funder. Whoever oversees the clinical
trial. Could be PI if PI-initiated, or funder if funder-initiated.
IDE ✔Correct Answer-Clinical Trial Investigational Device Exemption
Process for "sponsor" to obtain FDA approval to use an investigational new device.
Required for device clinical trials designed to evaluate safety and effectiveness
Approved IDE permits device to be shipped lawfully for the purpose of conducting investigations of
the device without complying with other requirements of FD&C Act
AE ✔Correct Answer-(Clinical Trial) Adverse Event
Any type of health issue that occurs in a clinical trial participant
- very common in clinical trials
- may or may not be related to the intervention
SAE ✔Correct Answer-(Clinical Trial) Serious Adverse Event
According to 21 CFR 312.32(a)
"An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the
investigator or sponsor, it results in any of the following outcomes:
1. Death
2. A life-threatening adverse event
3. Inpatient hospitalization or prolongs hospitalization
4. Significant life disruption
5. congenital anomaly/birth defect
Nuremberg Code ✔Correct Answer-(1947) First international standard in response to Nazi
atrocities
Comprised of 10 points - introduced IC
Framework for performing experiements
Nuremberg Code: 10 Ethical Principles (1-5) ✔Correct Answer-1. Research participants must
voluntarily consent to research participation
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid any unnecessary physical and mental suffering
5. No research projects can go forward where serious injury and/or death are potential outcomes
Nuremberg Code: 10 Ethical Principles (6-10) ✔Correct Answer-6. The degree of risk taken with
research participants cannot exceed anticipated benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at any time
10. Scientist must be prepared to terminate the experiment if there is cause to believe that
continuation will be harmful or result in injury or death
Nuremberg Code summarized by three categories ✔Correct Answer-Participants, Researchers,
Research
Nuremberg code eventually led to ✔Correct Answer-ICH-GCP (International Conference on
Harmonization - Good Clinical Practice) referred to as GCPs - created at conference in 1996 and
endorsed by FDA in 1997 - 13 principles (read principles separately)
FALL 2026 WITH ALL CORRECT & 100% VERIFIED
ANSWERS|ALREADY GRADED A+
FAIN ✔Correct Answer-Federal Award Identification Number
IHE ✔Correct Answer-Institution of Higher Education
COSO ✔Correct Answer-Committee of Sponsoring Organizations of the Treadway Commission -
1985
2013 Internal Controls Framework to combat corporate fraud
EUI ✔Correct Answer-Energy Usage Index
FAC ✔Correct Answer-Federal Audit Clearinghouse
FAPIIS ✔Correct Answer-Federal Awardee Performance Integrity and Information System
GOCO ✔Correct Answer-Government owned, Contractor operated
IBS ✔Correct Answer-Institutional Base Salary
PII ✔Correct Answer-Personally Identifiable Information
PRHP ✔Correct Answer-Post-retirement Health Plans
PTE ✔Correct Answer-pass-through entity
REUI ✔Correct Answer-Relative Energy Usage Index
SPOC ✔Correct Answer-Single Point of Contact
TFM ✔Correct Answer-Treasury Financial Manual
The TFM is the Department of the Treasury's official publication of policies, procedures, and
instructions concerning financial management in the Federal Government.
VAT ✔Correct Answer-Value Added Tax
ITAR ✔Correct Answer-International Trafficking in Arms Regulations (22 CFR 120-130) US State
Department, Directorate of Defense Trade Controls (DDTC), defense articles/tech/data, services on
US Munitions List, primarily military, space, and intelligence application, no sharing with non-US
persons AT ALL
EAR ✔Correct Answer-Export Administration Regulations (15 CFR 300-799), US Department of
Commerce, Bureau of Industry and Security (BIS), commodities, software, and technology on the
Commerce Control List, primarily commercial/civilian, sliding scale, exports may occur after a
licensing evaluation
,NRC & DOE ✔Correct Answer-Nuclear Regulatory Commission (NRC) (10 CFR 110) & US
Department of Energy (DOE) (10 CFR 810) · Nuclear reactors, fuel, sensitive nuclear technologies, etc.
FACR ✔Correct Answer-Foreign Asset Control Regulations (31 CFR 500-599), US Department of
Treasury, Office of Foreign Asset Control (OFAC), Sanctioned transactions for good and services
involving: comprehensively sanctioned countries: Cuba, Syria, North Korea, Iran, Individuals or
organizations on US Government Restricted Party List
What prevents violations? ✔Correct Answer-Restricted Party Screening!
Regulatory Exclusions related to exports and sanctions (cover most IHEs) ✔Correct Answer-1.
Public Domain, 2. Educational Information, 3. Fundamental Research
U.S. laws and regulations that regulate and restrict the release of critical items, technologies and
services to foreign nationals, within and outside of the United States, and foreign countries for
reasons of foreign policy and national security. ✔Correct Answer-Export Controls
programs are administered and enforced by the Office of Foreign Asset Control (OFAC) and utilize the
blocking of assets and trade restrictions to accomplish foreign policy and national security goals.
Prohibited transactions are trade or financial transactions and other dealings in which U.S. persons
may not engage unless authorized by OFAC or expressly exempted by statute. U.S. persons must
comply with OFAC regulations, including all U.S. citizens and permanent resident aliens regardless of
where they are located, all persons and entities within the United States, all U.S. incorporated
entities and their foreign branches. ✔Correct Answer-Sanctions
Exports ✔Correct Answer-· Physical Exports (outside US borders)
· Deemed Exports (inside the US)
US Persons ✔Correct Answer-· US Citizens
· Lawful Permanent Residents (Green Card Holders)
· Protected political status (asylee, refugee, amnesty)
· US Companies (incorporated to do business in US)
Fundamental Research ✔Correct Answer-A systematic investigation, including research
development, testing and evaluation designed to develop or contribute to generalizable knowledge
Clinical Research ✔Correct Answer-Broad: study of health and illness in people, Narrow: study of a
product in the body - effects and absorption/distribution
Clinical Trial ✔Correct Answer-(each institution has its own definition but similar key elements) - A
research project to test safety and efficacy of a drug, device, or other treatment; must develop or
contribute to generalizable knowledge. KEY: administering an intervention
Four Phases ✔Correct Answer-Number of phases in a Clinical Trial
Clinical Trial Protocol ✔Correct Answer-1. establishes the primary outcome, 2. Establishes patient
inclusion/exclusion criteria, 3. determines feasibility and budget, 4. verifies how data will be
collected and managed
3 Main Types of Clinical Trials Research ✔Correct Answer-1. Patient-oriented research, 2.
Epidemiological and behavioral studies, 3. Outcomes and health services research
,Pre-Clinical Phase ✔Correct Answer-1. Protocol development, 2. animal testing, 3. funding
applications, 4. IRB approvals
Phase I (Clinical Trial) ✔Correct Answer-Testing of new treatment on a small group of HEALTHY
subjects to determine dosage and side effects. Key Characteristics - 1. ~20-80 HEALTHY volunteers,
determine safety of drug in humans, determine basic (baseline) information of impact on humans.
Phase II Clinical Trial ✔Correct Answer-New treatment expanded to larger group of AFFLICTED
subjects with targeted disease/condition. Key characteristics - 1. subjects randomized (RCT), 2. Adds
a blinded control group (placebo), 3. ~100-300 patients with disease or condition, 4. Go/no-go point
(lowest point of success rate)
Phase III Clinical Trial ✔Correct Answer-Study expanded and new treatment given to large group of
afflicted subjects, usually at multiple sites. Key characteristics - 1. Usually double-blinded (both
providers and patients), 2. Confirms efficacy and safety
3., ~1,000 - 3,000 patient volunteers
After Phase III before Phase IV of Clinical Trial ✔Correct Answer-Apply for FDA approval
Phase IV Clinical Trial ✔Correct Answer-Studies long-term effectiveness, comparing new treatment
to standard treatment. Obtain additional information about risks, benefits, and optimal use. Key
characteristics - 1. intervention is already approved, 2. post-marketing/evaluating intervention use in
public, 3. refine dosage and side effects
CRF ✔Correct Answer-Clinical Trial Case Report Form
Case report forms contain data obtained during the patient's participation in the clinical trial. Before
being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing
the patient's name, medical record number, etc., and giving the patient a unique study number.
CRO ✔Correct Answer-Clinical Trial Contract Research Organization - "translates" between sponsor
and clinical trial site
ICF ✔Correct Answer-Informed Consent Form - a process, not just a signed form
Discussion - Review - Concerns - Time - Signatures
Essential Elements of Informed Consent ✔Correct Answer-1. Research description, 2. Risk, 3,
Benefits, 4. Alternatives, 5. Confidentiality, 6. Compensation, 7. Contacts, 8. Voluntary participation
or withdrawal
IND ✔Correct Answer-Clinical Trial - Investigational New Drug
Process for "sponsor" to obtain FDA approval to use an investigational new drug.
Investigator IND ✔Correct Answer-submitted by physician who initiates & conducts the study
Emergency IND ✔Correct Answer-Allows the FDA to authorize use of experimental drug in
emergency situation
Treatment IND ✔Correct Answer-Submitted for experimental new drugs showing promise in
clinical testing for serious or immediately threatening conditions
, Clinical Trial "Sponsor" ✔Correct Answer-Not necessarily the funder. Whoever oversees the clinical
trial. Could be PI if PI-initiated, or funder if funder-initiated.
IDE ✔Correct Answer-Clinical Trial Investigational Device Exemption
Process for "sponsor" to obtain FDA approval to use an investigational new device.
Required for device clinical trials designed to evaluate safety and effectiveness
Approved IDE permits device to be shipped lawfully for the purpose of conducting investigations of
the device without complying with other requirements of FD&C Act
AE ✔Correct Answer-(Clinical Trial) Adverse Event
Any type of health issue that occurs in a clinical trial participant
- very common in clinical trials
- may or may not be related to the intervention
SAE ✔Correct Answer-(Clinical Trial) Serious Adverse Event
According to 21 CFR 312.32(a)
"An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the
investigator or sponsor, it results in any of the following outcomes:
1. Death
2. A life-threatening adverse event
3. Inpatient hospitalization or prolongs hospitalization
4. Significant life disruption
5. congenital anomaly/birth defect
Nuremberg Code ✔Correct Answer-(1947) First international standard in response to Nazi
atrocities
Comprised of 10 points - introduced IC
Framework for performing experiements
Nuremberg Code: 10 Ethical Principles (1-5) ✔Correct Answer-1. Research participants must
voluntarily consent to research participation
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid any unnecessary physical and mental suffering
5. No research projects can go forward where serious injury and/or death are potential outcomes
Nuremberg Code: 10 Ethical Principles (6-10) ✔Correct Answer-6. The degree of risk taken with
research participants cannot exceed anticipated benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at any time
10. Scientist must be prepared to terminate the experiment if there is cause to believe that
continuation will be harmful or result in injury or death
Nuremberg Code summarized by three categories ✔Correct Answer-Participants, Researchers,
Research
Nuremberg code eventually led to ✔Correct Answer-ICH-GCP (International Conference on
Harmonization - Good Clinical Practice) referred to as GCPs - created at conference in 1996 and
endorsed by FDA in 1997 - 13 principles (read principles separately)
