6/4/2016 2015­2016 Test

October 2015 - April 2016

2015­2016 IPPCR Test
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.
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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. All of the above

e. 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:

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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

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e. All of the above

19. What can change a study's power and how is power impacted?

a. Sample size (n): power increases as sample size increases

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

c. Variation in outcome (σ2): power decreases as an outcome’s 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

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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

d. None of the above

26. Which of the following is TRUE about self-report measures?

a. The respondent’s 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 agreeable 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

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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 subject’s 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.

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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 subject’s 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
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 41. If
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2015­2016 Test 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 evaluating whether individuals can give informed consent for clinical research.

a. True

b. False

45. The name of the conceptual structure of a group of people of different disciplines who each report to
someone OUTSIDE the team structure is known as a Matrix model team:

a. True

b. False

46. Which of the following is NOT an example of a source document?

a. Pathology report

b. A handwritten daily diary such as a pain log maintained by the patient

c. Nurse’s notes in the medical record

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

a. True

b. False

48. 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

49. 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

50. It is the research nurse’s responsibility to determine whether an adverse event is related to the medical
treatment of procedure.

a. True

b. False

51. 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

52. Which of these is NOT considered to be research misconduct?

a. In your manuscript copying verbatim a paragraph from another scientist’s 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

Changing some of the numbers in a table so that the standard error is smaller
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d. Changing some of the numbers in a table so that the standard error is smaller

53. 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

54. 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

55. 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

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

a. True

b. False

57. The United States Food and Drug Administration's "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

58. Clinical Data Interchange Standards Consortium (CDISC) End-to-End Standards do NOT include:

a. Study Data Tabulation Model (SDTM)

b. Analysis Data Model (ADaM)

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c. Clinical Data Awesomeness (CDA)

d. Clinical Data Acquisition Standards Harmonization (CDASH)

e. Operational Data Model (ODM)

59. “Real World Data” sources include claims databases, social media, electronic health records, patient
registries, randomized controlled trials, and smart phones.

a. True

b. False

60. Which of the following is/are reasons to perform audits as part of your organization’s 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

61. 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 informed consent is located in the patient’s medical record

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

d. Documentation in the patient’s medical record of study drug administration including dose, route, missed doses,
modified doses

62. 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

63. 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
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c. Audit

d. Inspection

64. Which of the following is a key clinical information database that is very similar in subject coverage to
PubMed, and is particularly valuable for drug, toxicology, conference and international information
coverage?

a. Web of Science

b. Scopus

c. Embase

d. Biosis

e. Micromedex

65. 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. Nothing involving DNA can be patented

e. 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

66. 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 party’s duty to mark each document having confidential information, “CONFIDENTIAL”

c. The disclosing party’s rights in future inventions made by the receiving party

d. Ground rules for how publication of research results will be enabled while preserving confidentiality of the original
information

e. How long the recipient’s duty to maintain confidentiality will last

67. 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

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68. 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

69. 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

70. 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

71. 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

72. When talking to a reporter it is important to be aware of terms of the journalistic trade. What does "On the
Record” mean?
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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

73. 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

74. 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

75. 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

76. 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

77. Under the United States’

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77. Under the United States’ Freedom of Information Act a document stamped "Confidential" may still be
released to the requester

a. True

b. False

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. “I’d be happy to talk with you, but I am not allowed”

c. “I’d 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

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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. All of the above

e. 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. Appropriateness of the Budget does not affect the Overall Impact Score

e. 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

Finalize Test

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