Test IPPCR

1. Which of the following is most likely a case series study?

a. Report of 5 cases of pneumocystis pneumonia in previously healthy homosexual
men
b. National survey of health and nutrition

c. Association study of maternal use of stilbesterol with tumor appearance

d. Observational study of cardiovascular health in men and women over 65

2. Which of the following statements about control groups or control arms in a
study is FALSE?
a. Control groups can take many different forms.

b. The specific question being addressed in the study directs the choice of the
control group or groups for the study.
c. All good studies have a placebo control arm.
3. Mark the TRUE statement about Blinding/Masking.
a. A purpose of blinding or masking is to reduce the possibility of bias impacting
study outcomes.
b. There are almost always design features that can be implemented to at least
partially mask a study.
c. A few of the different labels applied to studies include double-blind, single-
masked, assessor-masked, unmasked, or open-label.
d. Protocols should clearly specify who is masked, why, to what information each
person is masked, and the criteria for unmasking.
e. All of the above
4. Which of the following is a type of randomized study?
a. Group sequential trial

b. Historical control study

c. Cohort study

d. Case-control study
5. Epidemiology assumes disease has causal and preventative factors that can be
identified through systematic investigation.
a. Yes

b. No
6. The anachronism C.U.E. represents the cardinal elements of a desired and
important partnership between patient/volunteers and researchers. The letters C.U.E
.stand for Communication, Understanding, and Empathy.
a. True

b. False
7. The main purpose(s) of establishing exclusionary criteria is/are:
a. For balancing between-participant variance

b. For safety issues

c. To decrease potential confounding

d. B and C only
8. What are reasons for carefully considering selection of participants in a research
study:
a. The characteristics of your study participants could help determine your ability to
generalize findings
b. It could impact feasibility of your study

c. It may impact outcomes of your study

d. It can help clarify your question and study design

e. All of the above

9. Which of the following is NOT a legitimate way to randomize?
a. Using stratified randomization by clinical site

b. Using the last digit of the medical record number

c. Varying block size while using block randomization

d. Randomizing each patient to a treatment with a known probability

10. The more stratification variables, the better.
a. True

b. False
11. In multi-site trials, it is recommended to use site as a stratification variable.
a. True

b. False
12. Randomization is important because:
a. It keeps treatment allocation free from selection bias

b. It allows us to attribute differences in outcomes to differences in efficacy of the

treatments under study (causality)
c. Both a and b

d. None of the above

13. If gender is a stratification variable in a randomized controlled trial, we expect:
a. As many men as women in Treatment T1, and as many men as women in
Treatment T2.
b. As many men in Treatment T1 as in Treatment T2, and as many women in
Treatment T1 as in Treatment T2.
c. Both (a) and (b)

d. Neither (a) nor (b)

14. What does failing to reject H0 (the null hypothesis) mean?
a. There is not enough evidence in your sample to reject the null hypothesis.

b. The null hypothesis is true.

15. If the 95% confidence interval does not include the value of the null hypothesis
(e.g. of zero difference), the result is statistically significant at the 5% alpha level.
a. True

b. False
16. Power is the probability of detecting an effect when it actually exists.
a. True

b. False
17. The p-value is the probability that the null hypothesis (H0) is true.
a. True

b. False
18. The basic formulas for sample size use which of the following:
a. Type I error

b. Type II error

c. Variance

d. Difference (effect) to be detected

e. All of the above

19. What can change a studys power and how is power impacted?
a. Sample size (n): power increases as sample size increases

b. Difference (effect) to be detected (): power increases as this difference

increases.
c. Variation in outcome (2): power decreases as an outcomes variance increases

d. All of the above

20. In order to define the survival outcome variable we do NOT need to define which
of the following?
a. The event

b. The time origin

c. The time scale

d. The covariates

e. The time at which an event occurs

21. You are reviewing a manuscript with the results of an observational study that
looked at survival for several groups. The statistical methods section states stratified
logrank tests were performed to compare overall survival between groups. The figures
include several Kaplan-Meier curves and reports the p-values from the logrank tests.
The manuscript does not mention any other statistical methods. What other statistical
 analysis method could you recommend be used before making conclusions about the
study results?
a. The answer is always the same regardless of the statistical analysis method.
Kaplan Meier, any type of Cox regression, logistic regression, it does not matter which type of analysis
is used to evaluate the time-to-event or survival data.
b. The Cox proportional hazards model is the best method to use for time-to-event
analyses. You can always assume proportional hazards.
c. Cox models can be used to analyze the study data. Cox models can be used to
make inference about continuous and categorical covariates such as age and gender in time-to-event
models. For consistent unbiased estimates the Cox model requires independent censoring, either
directly or given the covariates in the model. The proportional hazards assumption should be
evaluated because it may not be true. There are Cox models that do not assume proportional hazards.
Also, depending on the study design there are other statistical analysis methods that may be
appropriate.
22. Does the Kaplan Meier have a sensible interpretation for competing risks?
a. Yes

b. No
23. Which of the following characteristics are the most important in determining a
good measure?
a. Cost and categorization

b. Feasibility and frequency of publication

c. Scale and specialization

d. Reliability and validity

24. An instrument designed to measure a Patient-Reported Outcome (PRO)
demonstrates validity when:
a. Research participants understand the items in the same way as the measure
developers
b. Patients whose health condition is stable will receive the same score after
repeated administrations of the measure
c. The instrument measures what it is supposed to measure (and nothing else)

d. The instrument contains more than two items

25. Newer measures of Patient-Reported Outcomes (PROs) are being developed
using a statistical approach known as Item Response Theory (IRT). Which of the
following is one of the benefits of measures developed using IRT?
a. Any and all items can be administered to obtain a valid score

b. Measures developed with IRT cost less to develop

c. Items are easier for people to understand

26. Which of the following is TRUE about self-report measures?
a. The respondents mood at the time of the survey is irrelevant

b. The respondent may be influenced by social desirability

c. Measurement error is not a concern

d. A blood pressure reading is an example
27. Factual data are objectively verifiable.
a. True

b. False
28. Respondents tend to give more socially acceptable answers when self-
responding versus giving answers to an interviewer.
a. True

b. False
29. Broad survey questions tend to work better than specific ones.
a. True

b. False
30. Which of the following is TRUE about cognitive testing?
a. Quantitative techniques are used to find common themes.

b. Focus of testing is mainly on the response options.

c. Participant characteristics should reflect the general population.

d. Participants start to lose focus after about an hour.

31. Which of the following is an example of secondary data?
a. Survey data

b. Administrative billing data

c. Disease Registry

d. Demographic data from a randomized trial

32. Secondary data are useful for which of the following reasons?
a. To study geographic variation in service delivery

b. To study the impact of a rare disease

c. To study the impact of a new health care policy

d. All of the above

33. Use of secondary data is limited by which of the following?
a. Missing data

b. Lack of clinical detail

c. Subject misclassification

d. All of the above

34. Disclosure of which of the following items is necessary for an informed consent
document?
a. The diagnosis or identification of a subjects condition or problem
b. The nature and purpose of the proposed treatment or intervention

c. The foreseeable risks and benefits of the proposed treatment or intervention

d. All of the above

35. An individual enrolled in a protocol at the NIH Clinical Center may appoint a
surrogate decision-maker to make medical and/or research decisions in the event s/he
becomes incapable through use of a Durable Power of Attorney for Health Care, also
known as a DPA.
a. True

b. False
36. Most guidelines, codes and regulations for ethical research include a
requirement for informed consent. The process of informed consent includes the
following elements:

a.
A written consent form with a disclaimer

b.
Understanding written information

c.
The signature of the participant

d.
Disclosure of information, understanding, voluntary choice, and authorization

37. Scientific validity is an important aspect of an ethical study. Assessing scientific

validity includes consideration of:
a. Sample size and study design

b. Costs and budget

c. Informed consent

d. Amount of compensation to participants

38. In the proposed ethical framework for clinical research, the final principle
respect for enrolled subjects is understood to include:
a. Establishing a contract between the subject and the researcher

b. Monitoring the subjects welfare and protecting confidentiality of information

c. Keeping the financial costs of participation reasonable

d. Informing the subject of new information only after the study is published
39. If you are conducting clinical research that is funded by the NIH, you are always
required to follow the Common Rule:
a. True

b. False
40. Planned interim data analyses that require analysis of unblinded data need to
be specified in the study protocol.
a. True

b. False
41. If the Data Safety Monitoring Board makes a recommendation to terminate a
study, the ultimate decision to end the study lies with
a. The Study Sponsor

b. The Institutional Review Board

c. The Date Safety Monitoring Board

42. Which of the following are responsibilities of the Data Safety Monitoring Board?
a. Monitor protocol compliance

b. Monitor enrollment

c. Monitor adverse events

d. All of the above

e. Answers a and c only

43. Which of the following are requirements for informed consent for clinical
research (choose all that apply):

a.
The individual must understand the study

b.
The individual must have the disease being studied

c.
The individual must agree that the study is important

d.
The individual must make a voluntary decision to enroll

e.
a&d

44. 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.
a. True

b. False
45. A GANNT chart may show the interdependencies of the following:
a. Timelines

b. Capital expenditures

c. Personnel required

d. All of the above

e. None of the above

46. You want to create a target product profile for your new drug, the best place to
get information on the different attributes for the Gold Standard you want to make
comparisons to is:
a. The latest review in Science

b. A textbook of pharmacology

c. The approved labeling

d. A and B

e. None of the above

47. Which of the following is NOT an example of a source document?
a. Pathology report

b. A signed and dated handwritten daily diary such as a pain log maintained by the
patient
c. Nurses notes in the medical record

d. A worksheet that has a patients height and weight abstracted or taken from data
in the medical record.
48. An event that prolongs a hospitalization for a patient in a clinical trial is
considered a serious adverse event:
a. True

b. False
49. What describes a properly designed Case Report Form (CRF)?
a. Collects relevant data in accordance with the protocol

b. Allows for efficient and complete data processing and analysis

c. Facilitates the pooling of data across studies

d. All of the above

50. When collecting key data on the Case Report Form (CRF) for analysis, all of the
following are true, EXCEPT:
a. Provide consistent units of measure to ensure comparable values

b. Include multiple open ended questions with free-text responses

c. Provide choices to questions to allow for efficient summarization

d. Avoid collecting the same data in different parts of the CRF

51. It is the research nurses responsibility to determine whether an adverse event
is related to the medical treatment of procedure.
a. True

b. False
52. Authorship is based on significant contribution to:
a. The conceptualization and design of the research project

b. The execution of the experiments

c. Writing of the paper

d. Assumption of responsibility for the entire study

e. All of the above

53. Which of these is NOT considered to be research misconduct?
a. In your manuscript copying verbatim a paragraph from another scientists
published manuscript with no attribution
b. Submitting a previously published table of data without attribution to the original
work
c. Preparing a figure for a paper using only those experiments which had laboratory
controls that worked
d. Changing some of the numbers in a table so that the standard error is smaller
54. The expedited programs that the United States Food and Drug Administration
(FDA) can use to facilitate drug development and approval are: fast track designation,
breakthrough therapy designation, accelerated approval, and priority review
designation.
a. True

b. False
55. What is the reason NIH requires the inclusion of women and minorities in all
clinical research?
a. United States legal requirement applicable to all NIH-supported investigators

b. Ethical principle of justice

c. Responses to clinical interventions may differ between males and females and/or
different racial and ethnic groups
d. All of the above
56. Since the implementation of the NIH inclusion policy:
a. Knowledge has been gained about differences in cardiovascular symptoms
between men and women
b. More research participants from minority groups have participated in clinical
research, particularly in Phase III clinical trials
c. More women than men have participated in clinical research

d. All of the above

57. Experimental design is concerned with reducing and controlling variability in
ways which make statistical theory applicable to decisions about nature.
a. True

b. False
58. The United States Food and Drug Administrations Gold Standard for approval
does NOT include:
a. Two adequate and well-controlled trials

b. 3 peer-reviewed journal articles

c. Pre-specified end-points

d. Clinical benefit
59. Clinical Data Interchange Standards Consortium (CDISC) End-to-End Standards
do NOT include:
a. Study Data Tabulation Model (SDTM)

b. Analysis Data Model (ADaM)

c. Clinical Data Awesomeness (CDA)

d. Clinical Data Acquisition Standards Harmonization (CDASH)

e. Operational Data Model (ODM)

60. Real World Data sources include claims databases, social media, electronic
health records, patient registries, randomized controlled trials, and smart phones.
a. True

b. False
61. Which of the following is/are reasons to perform audits as part of your
organizations Quality Assurance Programs?
a. To assure all patient protection measures are followed

b. To ensure protocol adherence

c. To find and correct errors

d. To ensure study results are valid

e. All of the above

62. All of the following are examples of what auditors/monitors look for during the
audit process EXCEPT:
a. Regulatory binder to include copies of current Clinical Laboratory Improvement
Amendment (CLIA) certificates for all labs used by patients on a study
b. Copy of the signed contract located in the patients budget sheet

c. All eligibility criteria are met prior to patient enrollment on study

d. Documentation in the patients medical record of study drug administration
including dose, route, missed doses, modified doses
63. Why do sponsors conduct monitoring visits?
a. Required by law and to try to find new investigators

b. Required by law and to check on the use of grant money

c. Required by law and to ensure that subjects rights are protected

64. What is a systematic and independent examination of trial-related activities and
documents to determine whether the evaluation trial-related activities were conducted
and the data were recorded, analyzed, and accurately reported according to the
protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and the
applicable regulatory requirements?
a. Amendment

b. Site Evaluation

c. Audit

d. Inspection
65. Which of the following is a key clinical information database that is most similar
to PubMed in subject coverage, and is particularly valuable for drug, toxicology,
conference and international information coverage?
a. Web of Science

b. Scopus

c. Embase

d. Biosis

e. Micromedex
66. Which of the following five statements is TRUE about patents?
a. The invention being patented must work significantly better than the prior
versions
b. To get worldwide patent protection, you will have to file a patent application in
each and every country
c. Patenting research tools is illegal

d. A non-confidential disclosure of your invention before any patent application has

been filed will not jeopardize patent rights if you only tell your friends
67. A typical Confidential Disclosure Agreement normally includes all but one of
the following items (in other words, select the one that is NOT normally there):
a. A general description of the information to be disclosed by each party

b. The disclosing partys duty to mark each document having confidential

information, CONFIDENTIAL
c. The disclosing partys rights in future inventions made by the receiving party

d. How long the recipients duty to maintain confidentiality will last

68. Implementation studies focus primarily on:
a. Whether and how an evidence-based intervention that is known to be efficacious
can be implemented in a real-world setting
b. Whether an intervention is efficacious in a highly selected sample of research
participants
c. Whether a treatment can be implemented in a highly selected sample of
research participants
d. Whether and how an intervention that does not have known efficacy can be
implemented in a controlled setting
69. Differences in health outcomes among different demographic groups are the
result the complex interaction of several factors, including:
a. Cultural and racial/ethnic identity

b. Socioeconomic and occupational trajectory

c. Biology

d. Health care

e. Environment and geography

f. All of the above

70. A racial/ethnic difference in health care use can be considered a disparity after
the following factors have been evaluated:
a. Need and appropriateness of recommended treatment

b. Health outcomes

c. Racial/ethnic group beliefs influencing decision making

d. Comorbidities

e. All of the above

71. When preparing a budget for a clinical trial, what should you consider?
a. The effort of the coordinator and Principal Investigator (PI)

b. The procedures that will be done by another department

c. The overhead of your organization

d. All of the above

e. None of the above

72. To protect the liability of your patient and your organization, what can you do?
a. Pre-certify each patients insurance coverage as it pertains to research
participation
b. State clearly in the informed consent what items will be paid for by the study
budget, and what items will be the patients responsibility
c. Set up in advance of enrollment a way to capture study patients in the billing
system to prevent double billing
d. All of the above
e. None of the above
73. When talking to a reporter it is important to be aware of terms of the journalistic
trade. What does "On the Record mean?
a. This means that a reporter cannot use your information in a story as coming from
you; however, the reporter can use it in other ways such as getting another source to respond to your
comment
b. This means that the reporter can use the information you give, including direct
quotes, but you are not to be named. You may be identified as a NIH scientist, or a knowledgeable NIH
source
c. This means that a reporter can quote you directly, using your name and title
74. When talking to a reporter it is important to be aware of terms of the journalistic
trade. What does not for attribution and on background mean?
a. This means that a reporter cannot use your information in a story as coming from
you; however, the reporter can use it in other ways such as getting another source to respond to your
comment
b. This means that the reporter can use the information you give, including direct
quotes, but you are not to be named. You may be identified as a NIH scientist, or a knowledgeable NIH
source
c. This means that a reporter can quote you directly, using your name and title
75. When talking to a reporter it is important to be aware of terms of the journalistic
trade. What does "Off the Record" mean?
a. This means that the a reporter cannot use your information in a story as coming
from you; however, the reporter can use it in others ways such as getting another source to respond to
your comment
b. This means that the reporter can use the information you give, including direct
quotes, but you are not to be named. You may be identified as a NIH scientist or a knowledgeable NIH
source
c. This means that a reporter can quote you directly, using your name and title
76. Despite the ground rules, when talking to a reporter it is always best to be?
a. On the record

b. Not for attribution and on background

c. Off the record

77. The United States Freedom of Information Act (FOIA) provides individuals with a
right to access records in the possession of the federal government. Which item best
describes what may be available under the FOIA?
a. Minutes of NIH Institution Review Boards

b. Your computer files

c. Document drafts

d. Your e-mail messages

e. Approved research protocols

f. All of the above

78. The best response for you to give when a reporter contacts you directly is?
a. Sure, I can talk with you right now. What would you like to talk about?

b. Id be happy to talk with you, but I am not allowed

c. Id be happy to talk with you. Would you coordinate this with my Communication
Office?
79. Which of the following are examples of engagement approaches to conducting
clinical research studies in community settings?
a. Practice-based research networks (PBRNs)

b. Community-based participatory research (CBPR)

c. Community-oriented primary care (COPC)

d. All of the above

80. Which of the following is an important principle of community engagement for
community-based participatory research?
a. Make certain to only tell one community leader about the purpose of your
engagement and research effort
b. Only spend time in the community once you have prepared your research
protocol for review by community leaders
c. Be clear about the purposes or goals of the community engagement effort, and
the populations and/or communities you want to engage
d. Only commit to the community engagement for the short term (as long as
funding remains available)
81. What is the purpose of having a detailed protocol for each clinical trial?
a. Provide clear instructions so that the study procedures can be carried out the
same way with all participants
b. Provide detailed instructions for training new staff if there is turn over

c. Improve the likelihood of reproducibility of the trial results by providing detailed

documentation of how the trial was conducted
d. All of the above
82. Overall NIH success rates for clinical research grants are lower than success
rates for basic research grants because:
a. Clinical research grants are assigned to study sections with inappropriate
scientific expertise
b. Clinical research grants are harder to design well and the Principal Investigator
may give up rather than revise and resubmit his/her application
c. Clinical research grants have higher requested budgets and do not do as well
during review
d. None of the above
83. Which of the following statement(s) about the NIH Dual Review System is TRUE?

a.
The Scientific Review Group constitutes the first level of review
b.
The Advisory Council constitutes the second level of review

c.
The Scientific Review Group makes funding decisions

d.
a and b

e.
a, b, and c are all true

84. Which of the following statements about the NIH first level of review is FALSE?
a. The NIH Scoring Scale goes from 1 to 9

b. There are five core review criteria: Significance, Investigator, Innovation,

Approach, Environment
c. The Overall Impact Score is determined by averaging the subscores for the five
core review criteria
d. The Review Group can defer the review of an application if they need more
information to score it
85. A successful NIH grant submission include(s):
a. Understanding the psychology of the review process

b. Beginning the submission process early

c. Performing a critical self-assessment

d. Examination of currently funded research in the area

e. All of the above