CITI TRAINING QUIZ EXAM NEWEST 2026-2027
ACTUAL EXAM WITH COMPLETE 200
QUESTIONS AND CORRECT DETAILED
ANSWERS (100% VERIFIED ANSWERS)
ALREADY GRADED A+ PROFESSOR VERIFIED
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic
neuropathy. While the study is ongoing, a new drug becomes commercially available that may
have equal or greater benefit to the subject. The investigator should do which of the following?
A. Discuss the pros and cons of both the investigational drug and the commercially available
drug and then allow the subject to decide whether to withdraw from the research to take the new
drug.
B. Tell the subject about the new drug but discourage him from switching treatments until the
study is completed
C. Withhold this new information to avoid confusing the subject with other treatment options or
alternatives
D. Do not tell the subject about the new drug since physicians have the right to try out new
treatments with their patients - CORRECT ANSWER: Discuss the pros and cons of both the
investigational drug and the commercially available drug and then allow the subject to decide
whether to withdraw from the research to take the new drug.
A researcher wants to conduct a secondary analysis using a Centers for Disease Control and
Prevention (CDC) database that was collected by the agency solely for surveillance purposes
from 1996-2006. The researcher did not participate in the initial collection of the data. The
database is publicly available. The database does not include any identifiers. The IRB makes a
determination that the individuals whose records will be reviewed do not meet the federal
definition of human subjects.
Which of the following considerations was relevant to the IRB's determination that this activity
does not constitute research with human subjects? - CORRECT ANSWER: The researcher will
not be interacting/intervening with subjects and the data has no identifiers.
,According to U.S. Federal Research Misconduct Policy, which of the following is considered to
be research misconduct?
A. Gift authorship
B. Plagiarism
C. Conflict of interest
D. Harassing a co-worker - CORRECT ANSWER: B. Plagiarism
An investigator is confronted with a life-threatening situation that necessitates using a test article
in a human subject who is unable to provide informed consent and there is no time to obtain
consent for the individual's legal representative. Under the FDA regulations, which of the
following describes the best course of action for the investigator:
A. Do not use the test article until either the subject or the subject's legally authorized
representative can give consent.
B. Submit a research protocol to the IRB and justify an expedited review approval of the consent
document so the test article can be used immediately.
C. The investigator and another physician not part of the study team agree that the situation
necessitates the use of the test article and the IRB will be notified later.
D. Sign the consent form on behalf of the subject and use the test article. - CORRECT
ANSWER: The investigator and another physician not part of the study team agree that the
situation necessitates the use of the test article and the IRB will be notified later.
An investigator obtains consent and HIPAA authorization from subjects to review their medical
records and HIV status. He plans to go back to the medical record, so the HIV status information
is stored along with subject identifiers in a database that he keeps on his laptop computer. His
laptop is stolen. This incident constitutes: - CORRECT ANSWER: A breach of confidentiality
As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of
research participants in NIH -funded genetic research for broad research use of data and data
sharing, even if the cell lines or specimens are: - CORRECT ANSWER: De-Identified
,At what point should a Data Manager get involved with the database development? - CORRECT
ANSWER: At study startup
Every member of a study team must define quality the same way in order to produce a high
quality database. - CORRECT ANSWER: False
Identify the example of when situation and time are key to assessing risk of harm in a research
study: - CORRECT ANSWER: Asking women if they have had an abortion
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA)
protects individuals from: - CORRECT ANSWER: Health insurance and employment
discrimination
If a researcher creates the idea for a project and is not listed in the preferred author order position
on resulting publications, is this considered to be research misconduct under federal policy?
A. Yes because it involves a form of falsification.
B. No; instead it is a type of authorship dispute.
C. No; instead it is a type of financial conflict of interest.
D. Yes because it involves a form of fabrication. - CORRECT ANSWER: B. No; instead it is a
type of authorship dispute.
If disclosure of a subject's involvement in a specific research study can be potentially harmful to
the subject, and the consent form is the only record linking the subject to the research, which of
the following would be most helpful:
A. Obtain a waiver of documentation of informed consent.
B. Have the subject sign the consent form under an assumed name.
C. Code the subjects' responses.
, D. Obtain a Certificate of Confidentiality. - CORRECT ANSWER: A. Obtain a waiver of
documentation of informed consent.
In order for a quality process to work, study team members must understand all of the following
EXCEPT: - CORRECT ANSWER: how to perform the other team members' jobs
In order to grant a waiver or alteration of the requirements of informed consent, an IRB must
find ? - CORRECT ANSWER: The research could not practicably be carried out without the
waiver of consent.
Informed consent is considered an application of which Belmont principle?
A. Beneficence
B. Justice
C. Non-maleficence
D. Respect for Persons - CORRECT ANSWER: Respect for persons
Prior to locking a database, a data manager should ensure all data have been entered and all
queries are resolved. - CORRECT ANSWER: True
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
A. Invasion of privacy, adverse reaction to study drug, and discrimination
B. Breach of confidentiality, loss of autonomy, and study procedures
C. Invasion of privacy, breach of confidentiality, and study procedures
D. Study procedures, breach of confidentiality, and loss of employment - CORRECT ANSWER:
Invasion of privacy, breach of confidentiality, and study procedures
ACTUAL EXAM WITH COMPLETE 200
QUESTIONS AND CORRECT DETAILED
ANSWERS (100% VERIFIED ANSWERS)
ALREADY GRADED A+ PROFESSOR VERIFIED
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic
neuropathy. While the study is ongoing, a new drug becomes commercially available that may
have equal or greater benefit to the subject. The investigator should do which of the following?
A. Discuss the pros and cons of both the investigational drug and the commercially available
drug and then allow the subject to decide whether to withdraw from the research to take the new
drug.
B. Tell the subject about the new drug but discourage him from switching treatments until the
study is completed
C. Withhold this new information to avoid confusing the subject with other treatment options or
alternatives
D. Do not tell the subject about the new drug since physicians have the right to try out new
treatments with their patients - CORRECT ANSWER: Discuss the pros and cons of both the
investigational drug and the commercially available drug and then allow the subject to decide
whether to withdraw from the research to take the new drug.
A researcher wants to conduct a secondary analysis using a Centers for Disease Control and
Prevention (CDC) database that was collected by the agency solely for surveillance purposes
from 1996-2006. The researcher did not participate in the initial collection of the data. The
database is publicly available. The database does not include any identifiers. The IRB makes a
determination that the individuals whose records will be reviewed do not meet the federal
definition of human subjects.
Which of the following considerations was relevant to the IRB's determination that this activity
does not constitute research with human subjects? - CORRECT ANSWER: The researcher will
not be interacting/intervening with subjects and the data has no identifiers.
,According to U.S. Federal Research Misconduct Policy, which of the following is considered to
be research misconduct?
A. Gift authorship
B. Plagiarism
C. Conflict of interest
D. Harassing a co-worker - CORRECT ANSWER: B. Plagiarism
An investigator is confronted with a life-threatening situation that necessitates using a test article
in a human subject who is unable to provide informed consent and there is no time to obtain
consent for the individual's legal representative. Under the FDA regulations, which of the
following describes the best course of action for the investigator:
A. Do not use the test article until either the subject or the subject's legally authorized
representative can give consent.
B. Submit a research protocol to the IRB and justify an expedited review approval of the consent
document so the test article can be used immediately.
C. The investigator and another physician not part of the study team agree that the situation
necessitates the use of the test article and the IRB will be notified later.
D. Sign the consent form on behalf of the subject and use the test article. - CORRECT
ANSWER: The investigator and another physician not part of the study team agree that the
situation necessitates the use of the test article and the IRB will be notified later.
An investigator obtains consent and HIPAA authorization from subjects to review their medical
records and HIV status. He plans to go back to the medical record, so the HIV status information
is stored along with subject identifiers in a database that he keeps on his laptop computer. His
laptop is stolen. This incident constitutes: - CORRECT ANSWER: A breach of confidentiality
As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of
research participants in NIH -funded genetic research for broad research use of data and data
sharing, even if the cell lines or specimens are: - CORRECT ANSWER: De-Identified
,At what point should a Data Manager get involved with the database development? - CORRECT
ANSWER: At study startup
Every member of a study team must define quality the same way in order to produce a high
quality database. - CORRECT ANSWER: False
Identify the example of when situation and time are key to assessing risk of harm in a research
study: - CORRECT ANSWER: Asking women if they have had an abortion
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA)
protects individuals from: - CORRECT ANSWER: Health insurance and employment
discrimination
If a researcher creates the idea for a project and is not listed in the preferred author order position
on resulting publications, is this considered to be research misconduct under federal policy?
A. Yes because it involves a form of falsification.
B. No; instead it is a type of authorship dispute.
C. No; instead it is a type of financial conflict of interest.
D. Yes because it involves a form of fabrication. - CORRECT ANSWER: B. No; instead it is a
type of authorship dispute.
If disclosure of a subject's involvement in a specific research study can be potentially harmful to
the subject, and the consent form is the only record linking the subject to the research, which of
the following would be most helpful:
A. Obtain a waiver of documentation of informed consent.
B. Have the subject sign the consent form under an assumed name.
C. Code the subjects' responses.
, D. Obtain a Certificate of Confidentiality. - CORRECT ANSWER: A. Obtain a waiver of
documentation of informed consent.
In order for a quality process to work, study team members must understand all of the following
EXCEPT: - CORRECT ANSWER: how to perform the other team members' jobs
In order to grant a waiver or alteration of the requirements of informed consent, an IRB must
find ? - CORRECT ANSWER: The research could not practicably be carried out without the
waiver of consent.
Informed consent is considered an application of which Belmont principle?
A. Beneficence
B. Justice
C. Non-maleficence
D. Respect for Persons - CORRECT ANSWER: Respect for persons
Prior to locking a database, a data manager should ensure all data have been entered and all
queries are resolved. - CORRECT ANSWER: True
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
A. Invasion of privacy, adverse reaction to study drug, and discrimination
B. Breach of confidentiality, loss of autonomy, and study procedures
C. Invasion of privacy, breach of confidentiality, and study procedures
D. Study procedures, breach of confidentiality, and loss of employment - CORRECT ANSWER:
Invasion of privacy, breach of confidentiality, and study procedures
