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NIH Principles and Practices of Clinical Research.docx 1. Document information

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NIH Principles and Practices of Clinical
Research (IPPCR) Final Exam 2024-2025
Imhotep - CORRECT ANSWERS-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 - CORRECT ANSWERS-Father of modern medicine; Hipprocratic oath -->
high moral standards.
Which of the following is most likely a case series study? - CORRECT ANSWERS-
Report of 5 cases of pneumocytosis pneumonia in previously healthy homosexual men
Scientific misconduct can cause which of the following? - CORRECT ANSWERS-All of
the above
What is/are the reason(s) that NIH requires the inclusion of women and minorities in all
clinical research? - CORRECT ANSWERS-All of the above
What can change a study's power and how power is impacted? - CORRECT
ANSWERS-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:
- CORRECT ANSWERS-An audit performed to investigate possible fraud or misconduct
The use of common data elements (CDEs) should meet all of the following objectives
EXCEPT: - CORRECT ANSWERS-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. - CORRECT ANSWERS-False
An h-index is a way to: - CORRECT ANSWERS-Measure an author's productivity and
impact
Clinical trial registration is important so that: - CORRECT ANSWERS-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. - CORRECT ANSWERS-False
Scientific misconduct includes all of the following EXCEPT: - CORRECT ANSWERS-
human error
Which of the following four statements is TRUE about patents? - CORRECT
ANSWERS-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? - CORRECT
ANSWERS-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. - CORRECT ANSWERS-True
A potential barrier to recruitment in clinical trials is/are: - CORRECT ANSWERS-all of
the above

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Subido en
6 de julio de 2025
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4
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2024/2025
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