20152016 IPPCR Test: October 2015 - April 2016

6/4/2016

2015- 2016 Test

October 2015 - April 2016

2015-2016 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 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 https://i ppcr.ni htr ai ni ng.com/test.php

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2015- 2016 Test

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 c arefully 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







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a.

It keeps treatment allocation free from selection bias

b.

It allows us to attribute differences in outcomes to differences i n 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 H 0 (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 (H 0) is true. a.

True

b.

False







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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 f or 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 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? risks? a.

Yes

b.

No







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2015- 2016 Test

d.

Reliability and validity

24. An instrument designed to measure a Patient-Reported Outcome (PRO) demonstrates validity when: a.

Research participants understand 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 i s 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. b

True







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30. Which of the following is TRUE about cognitive testing? a.

Quantitative techniques 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









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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 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







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2015- 2016 Test

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 c linical research. a.

True







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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:







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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







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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 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









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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







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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







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2015- 2016 Test

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.







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2015- 2016 Test

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?” 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 Community-orient ed primary care (COPC)

d.

All of the above







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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

2015­2016 IPPCR Test: October 2015 - April 2016

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