CITI Training HFH- General Exam Study
Guide – Practice Questions & Verified
Answers
Looking for a reliable way to ace your exams with confidence? This comprehensive study
guide is designed to help students fully understand course material, sharpen critical thinking
skills, and perform at their best in assessments.
Unlike basic revision notes, this resource focuses on exam-style practice questions that mirror
the structure, difficulty, and expectations of real exams. Every question is paired with clear,
accurate answers and detailed explanations, ensuring you understand why an answer is
correct—not just what to memorize.
What You’ll Get Inside:
✔ Extensive coverage of essential and frequently tested topics
✔ Exam-level practice questions aligned with course objectives
✔ Step-by-step explanations to simplify complex concepts
✔ Clean, structured formatting for fast and effective revision
✔ Updated content based on current academic standards
Why Students Love This Guide:
This study resource is perfect for last-minute revision, structured study planning, and
strengthening weak areas. It helps you identify knowledge gaps, improve test-taking
strategies, and approach exams with clarity and confidence.
Ideal For:
• Final exam preparation
• Midterm reviews
• Weekly study sessions
• Catching up on difficult topics
• Boosting grades and overall academic performance
,Whether you’re preparing days or weeks in advance, this guide provides the support, clarity,
and practice needed to succeed. It is a powerful supplementary tool designed to help you
study smarter, not harder.
A must-have resource for students who want results.
Which of the following is likely to be the level of review determined as appropriate by the
IRB?
Exempt as the study presents no greater than minimal risk and does not collect identifying
information.
Would this research be eligible for exemption?
No. The investigator may be able to identify subjects based on telephone numbers and birth
dates, so this should not be considered exempt.
An investigator has proposed a multi-site study of PSA (Prostate Specific Antigen) test results
among patients with prostate cancer. The research involves only review of medical records at
institutions in several states. The investigator will not collect any identifying information on
the subjects, only their PSA scores and ages (which will be collected in a range format so as to
not have the person's specific age). The investigator may correctly conclude that:
IRB review, or similar process, may be required since generally investigators are not able to
exempt their own research.
Decisions about compliance with HIPAA's research provisions may sometimes be made by:
An organization's IRB, "Privacy Board", "Privacy Officer", or "Security Officer," depending on the
particular issue and the requirements of the HIPAA regulations.
Under HIPAA, a "disclosure accounting" is required:
for all human subjects research that uses PHI without an authorization from the data subject,
except for limited data sets.
If you're unsure about the particulars of HIPAA research requirements at your organization or
have questions, you can usually consult with:
An organizational IRB or Privacy Board, "Privacy Officer", or "Privacy Official," depending on the
issue.
The HIPAA "minimum necessary" standard applies
, to all human subjects research that uses PHI without an authorization from the data subject.
HIPAA includes in its definition of "research" the activities related to
development of generalizable knowledge.
A covered entity may use or disclose PHI without an authorization, or documentation of a
waiver or an alteration of authorization, for all of the following EXCEPT:
Data that does not cross state lines when disclosed by the covered entity.
HIPAA's protections for health information used for research purposes
supplement those of the Common Rule and FDA.
Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally
is research, and so requires either an authorization or meeting one of the criteria for a waiver of
authorization.
According to the PHS federal regulations entitled "Responsibility of Applicants for Promoting
Objectivity in Research" amended in 2011, the threshold for reporting significant financial
interests (investigator and his/her spouse and dependents) is:
Greater than $5,000 of ownership in any single public entity.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which
threshold:
$25,000
Significant financial interest, as defined by the 2011 final rule that amended Public Health
Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in
Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible
Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):
- Salary from an outside institution in excess of $5,000.
- Equity/stock interests in a non-publicly traded company.
- Intellectual property rights upon receipt of income related to such rights.
- Consulting payments in excess of $5,000.
When the sponsor-investigator holds the IND for an investigational drug he or she is
responsible for annual reporting of which one of the following to FDA?
IND report
Guide – Practice Questions & Verified
Answers
Looking for a reliable way to ace your exams with confidence? This comprehensive study
guide is designed to help students fully understand course material, sharpen critical thinking
skills, and perform at their best in assessments.
Unlike basic revision notes, this resource focuses on exam-style practice questions that mirror
the structure, difficulty, and expectations of real exams. Every question is paired with clear,
accurate answers and detailed explanations, ensuring you understand why an answer is
correct—not just what to memorize.
What You’ll Get Inside:
✔ Extensive coverage of essential and frequently tested topics
✔ Exam-level practice questions aligned with course objectives
✔ Step-by-step explanations to simplify complex concepts
✔ Clean, structured formatting for fast and effective revision
✔ Updated content based on current academic standards
Why Students Love This Guide:
This study resource is perfect for last-minute revision, structured study planning, and
strengthening weak areas. It helps you identify knowledge gaps, improve test-taking
strategies, and approach exams with clarity and confidence.
Ideal For:
• Final exam preparation
• Midterm reviews
• Weekly study sessions
• Catching up on difficult topics
• Boosting grades and overall academic performance
,Whether you’re preparing days or weeks in advance, this guide provides the support, clarity,
and practice needed to succeed. It is a powerful supplementary tool designed to help you
study smarter, not harder.
A must-have resource for students who want results.
Which of the following is likely to be the level of review determined as appropriate by the
IRB?
Exempt as the study presents no greater than minimal risk and does not collect identifying
information.
Would this research be eligible for exemption?
No. The investigator may be able to identify subjects based on telephone numbers and birth
dates, so this should not be considered exempt.
An investigator has proposed a multi-site study of PSA (Prostate Specific Antigen) test results
among patients with prostate cancer. The research involves only review of medical records at
institutions in several states. The investigator will not collect any identifying information on
the subjects, only their PSA scores and ages (which will be collected in a range format so as to
not have the person's specific age). The investigator may correctly conclude that:
IRB review, or similar process, may be required since generally investigators are not able to
exempt their own research.
Decisions about compliance with HIPAA's research provisions may sometimes be made by:
An organization's IRB, "Privacy Board", "Privacy Officer", or "Security Officer," depending on the
particular issue and the requirements of the HIPAA regulations.
Under HIPAA, a "disclosure accounting" is required:
for all human subjects research that uses PHI without an authorization from the data subject,
except for limited data sets.
If you're unsure about the particulars of HIPAA research requirements at your organization or
have questions, you can usually consult with:
An organizational IRB or Privacy Board, "Privacy Officer", or "Privacy Official," depending on the
issue.
The HIPAA "minimum necessary" standard applies
, to all human subjects research that uses PHI without an authorization from the data subject.
HIPAA includes in its definition of "research" the activities related to
development of generalizable knowledge.
A covered entity may use or disclose PHI without an authorization, or documentation of a
waiver or an alteration of authorization, for all of the following EXCEPT:
Data that does not cross state lines when disclosed by the covered entity.
HIPAA's protections for health information used for research purposes
supplement those of the Common Rule and FDA.
Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally
is research, and so requires either an authorization or meeting one of the criteria for a waiver of
authorization.
According to the PHS federal regulations entitled "Responsibility of Applicants for Promoting
Objectivity in Research" amended in 2011, the threshold for reporting significant financial
interests (investigator and his/her spouse and dependents) is:
Greater than $5,000 of ownership in any single public entity.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which
threshold:
$25,000
Significant financial interest, as defined by the 2011 final rule that amended Public Health
Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in
Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible
Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):
- Salary from an outside institution in excess of $5,000.
- Equity/stock interests in a non-publicly traded company.
- Intellectual property rights upon receipt of income related to such rights.
- Consulting payments in excess of $5,000.
When the sponsor-investigator holds the IND for an investigational drug he or she is
responsible for annual reporting of which one of the following to FDA?
IND report
