NIH IPPCR COMPLETE FINAL EXAM
Imhotep - ANSWER Egyptian, first physician figure to rise out of antiquity; known
scribe, priest, architect, astronomer and magician. performed surgery, practiced
some dentistry, extracted medicine from plants and knew the position and function of
vital organs.
Hippocrates - ANSWER Father of modern medicine; Hipprocratic oath --> high
moral standards.
Which of the following is most likely a case series study? - ANSWER Report of 5
cases of pneumocytosis pneumonia in previously healthy homosexual men
Scientific misconduct can cause which of the following? - ANSWER All of the
above
What is/are the reason(s) that NIH requires the inclusion of women and minorities in
all clinical research? - ANSWER All of the above
What can change a study's power and how power is impacted? - ANSWER
Variation in outcome (σ2): power decreases as an outcome's variance increases
A for-cause audit conducted by the Food and Drug Administration is best described
as: - ANSWER An audit performed to investigate possible fraud or misconduct
The use of common data elements (CDEs) should meet all of the following
objectives EXCEPT: - ANSWER To promote unneeded or redundant data
collection
True or False: Tests of general cognitive function, such as IQ tests and mini-mental
status exams (MMSE), provide effective tools for determining whether individuals
can give informed consent for a clinical trial. - ANSWER False
An h-index is a way to: - ANSWER Measure an author's productivity and impact
Clinical trial registration is important so that: - ANSWER A and B only
a) existing trials are publicly available; b) Trials are made publicly available even if
they are not finished
It is important to be able to replicate the randomization results, i.e., reproduce the
string of treatment assignments. - ANSWER False
Scientific misconduct includes all of the following EXCEPT: - ANSWER human
error
Which of the following four statements is TRUE about patents? - ANSWER To get
worldwide patent protection, you will have to file a patent application in each and
every country.
, Which of the following is NOT an example of a source document? - ANSWER A
worksheet that has a patient's height and weight abstracted or taken from data in the
medical record.
True or False: Planned interim data analyses, that require analysis of unblinded
data, need to be specified in the study protocol. - ANSWER True
A potential barrier to recruitment in clinical trials is/are: - ANSWER all of the above
Regarding the four major types of intellectual property, which of the following
statements is TRUE? - ANSWER A valid trademark lives for as long as the owner
actually uses it in commerce.
T or F: Excluded research is a type of research that is subject to the U.S. rules for
the protection of research subjects. - ANSWER False
Most guidelines, codes and regulations for ethical research include a requirement for
informed consent. The process of informed consent includes the following elements:
- ANSWER Disclosure of information, understanding, voluntary choice, and
authorization
What benefits should an IRB consider when deciding whether a study is acceptable?
- ANSWER Benefits to participants and to society from the knowledge learned
Scientific validity is: - ANSWER measures what it's supposed to measure. The
ability of a study to correctly answer the research question
Assuming similar access to healthcare services (including screening and
vaccinations), differences in incidence, prevalence and/or severity of a disease
between two populations may reflect: - ANSWER all the above
A research participant's decision to participate in research is "voluntary" according to
the US federal regulations if it is free from: - ANSWER C - coercion or undue
influence
Investigators' responsibilities do NOT include: - ANSWER Auditing of trial
With regard to risks to subjects from participating in research, which of the following
is/are true: - ANSWER All of the above
Coffee was reported to cause lung cancer until it was noted that coffee drinkers also
smoked. This is an example of: - ANSWER confounding!
Which of the following are responsibilities of the Data Safety Monitoring Board? -
ANSWER all of the above; Monitor protocol compliance
Monitor enrollment
Monitor adverse events
Imhotep - ANSWER Egyptian, first physician figure to rise out of antiquity; known
scribe, priest, architect, astronomer and magician. performed surgery, practiced
some dentistry, extracted medicine from plants and knew the position and function of
vital organs.
Hippocrates - ANSWER Father of modern medicine; Hipprocratic oath --> high
moral standards.
Which of the following is most likely a case series study? - ANSWER Report of 5
cases of pneumocytosis pneumonia in previously healthy homosexual men
Scientific misconduct can cause which of the following? - ANSWER All of the
above
What is/are the reason(s) that NIH requires the inclusion of women and minorities in
all clinical research? - ANSWER All of the above
What can change a study's power and how power is impacted? - ANSWER
Variation in outcome (σ2): power decreases as an outcome's variance increases
A for-cause audit conducted by the Food and Drug Administration is best described
as: - ANSWER An audit performed to investigate possible fraud or misconduct
The use of common data elements (CDEs) should meet all of the following
objectives EXCEPT: - ANSWER To promote unneeded or redundant data
collection
True or False: Tests of general cognitive function, such as IQ tests and mini-mental
status exams (MMSE), provide effective tools for determining whether individuals
can give informed consent for a clinical trial. - ANSWER False
An h-index is a way to: - ANSWER Measure an author's productivity and impact
Clinical trial registration is important so that: - ANSWER A and B only
a) existing trials are publicly available; b) Trials are made publicly available even if
they are not finished
It is important to be able to replicate the randomization results, i.e., reproduce the
string of treatment assignments. - ANSWER False
Scientific misconduct includes all of the following EXCEPT: - ANSWER human
error
Which of the following four statements is TRUE about patents? - ANSWER To get
worldwide patent protection, you will have to file a patent application in each and
every country.
, Which of the following is NOT an example of a source document? - ANSWER A
worksheet that has a patient's height and weight abstracted or taken from data in the
medical record.
True or False: Planned interim data analyses, that require analysis of unblinded
data, need to be specified in the study protocol. - ANSWER True
A potential barrier to recruitment in clinical trials is/are: - ANSWER all of the above
Regarding the four major types of intellectual property, which of the following
statements is TRUE? - ANSWER A valid trademark lives for as long as the owner
actually uses it in commerce.
T or F: Excluded research is a type of research that is subject to the U.S. rules for
the protection of research subjects. - ANSWER False
Most guidelines, codes and regulations for ethical research include a requirement for
informed consent. The process of informed consent includes the following elements:
- ANSWER Disclosure of information, understanding, voluntary choice, and
authorization
What benefits should an IRB consider when deciding whether a study is acceptable?
- ANSWER Benefits to participants and to society from the knowledge learned
Scientific validity is: - ANSWER measures what it's supposed to measure. The
ability of a study to correctly answer the research question
Assuming similar access to healthcare services (including screening and
vaccinations), differences in incidence, prevalence and/or severity of a disease
between two populations may reflect: - ANSWER all the above
A research participant's decision to participate in research is "voluntary" according to
the US federal regulations if it is free from: - ANSWER C - coercion or undue
influence
Investigators' responsibilities do NOT include: - ANSWER Auditing of trial
With regard to risks to subjects from participating in research, which of the following
is/are true: - ANSWER All of the above
Coffee was reported to cause lung cancer until it was noted that coffee drinkers also
smoked. This is an example of: - ANSWER confounding!
Which of the following are responsibilities of the Data Safety Monitoring Board? -
ANSWER all of the above; Monitor protocol compliance
Monitor enrollment
Monitor adverse events
