Report of 5 cases of pneumocystis pneumonia in previously healthy homosexual men National survey of health and nutrition
Association study of maternal use of stilbesterol with tumor appearance Observational study of cardiovascular health in men and women over 65 a.
b. c. d.
Control groups can take many different forms
The specific question being addressed in the study directs the choice of the control group or groups for the study All good studies have a placebo control arm
a. b. c.
A purpose of blinding or masking is to reduce the possibility of bias impacting study outcomes There are almost always design features that can be implemented to at least partially mask a study
A few of the different labels applied to studies include double-blind, single-masked, assessor-masked, unmasked, or open-label
Protocols should clearly specify who is masked, why, to what information each person is masked, and the criteria for unmasking
All of the above a.
b. c. d. e.
Group sequential trial Historical control study Cohort study Case-control study a. b. c. d. Yes No a. b. True False a. b. October 2015 - April 2016
20152016 IPPCR Test
1. Which of the following is most likely a case series study?
2. Which of the following statements about control groups or control arms in a study is FALSE?
3. Mark the TRUE statement about Blinding/Masking.
4. Which of the following is a type of randomized study?
5. Epidemiology assumes disease has causal and preventative factors that can be identified through systematic
investigation.
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.
For balancing between-participant variance For safety issues
To decrease potential confounding All of the above
B and C only a. b. c. d. e.
The characteristics of your study participants could help determine your ability to generalize findings It could impact feasibility of your study
It may impact outcomes of your study
It can help clarify your question and study design All of the above
a. b. c. d. e.
Using stratified randomization by clinical site Using the last digit of the medical record number Varying block size while using block randomization
Randomizing each patient to a treatment with a known probability a. b. c. d. True False a. b. True False a. b.
It keeps treatment allocation free from selection bias
It allows us to attribute differences in outcomes to differences in efficacy of the treatments under study (causality) Both a and b
None of the above a.
b. c. d.
As many men as women in Treatment T1, and as many men as women in Treatment T2 a.
7. The main purpose(s) of establishing exclusionary criteria is/are:
8. What are reasons for carefully considering selection of participants in a research study:
9. Which of the following is NOT a legitimate way to randomize?
10. The more stratification variables, the better.
11. In multi-site trials, it is recommended to use site as a stratification variable.
12. Randomization is important because:
As many men in Treatment T1 as in Treatment T2, and as many women in Treatment T1 as in Treatment T2 Both (a) and (b)
Neither (a) nor (b) b.
c. d.
There is not enough evidence in your sample to reject the null hypothesis The null hypothesis is true
a. b. True False a. b. True False a. b. True False a. b. Type I error Type II error Variance
Difference (effect) to be detected All of the above
a. b. c. d. e.
Sample size (n): power increases as sample size increases
Difference (effect) to be detected (δ): power increases as this difference increases. Variation in outcome (σ2): power decreases as an outcome’s variance increases All of the above
a. b. c. d.
The event The time origin a.
b.
14. What does failing to reject H
0(the null hypothesis) mean?
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.
16. Power is the probability of detecting an effect when it actually exists.
17. The p-value is the probability that the null hypothesis (H
0) is true.
18. The basic formulas for sample size use which of the following:
19. What can change a study's power and how is power impacted?
The time scale The covariates
The time at which an event occurs c.
d. e.
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 The Cox proportional hazards model is the best method to use for time-to-event analyses. You can always assume proportional hazards.
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 a. b. c. Yes No a. b.
Cost and categorization
Feasibility and frequency of publication Scale and specialization
Reliability and validity a.
b. c. d.
Research participants understand the items in the same way as the measure developers
Patients whose health condition is stable will receive the same score after repeated administrations of the measure The instrument measures what it is supposed to measure (and nothing else)
The instrument contains more than two items a.
b. c. d.
Any and all items can be administered to obtain a valid score Measures developed with IRT cost less to develop
Items are easier for people to understand a.
b. c. d.
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?
22. Does the Kaplan Meier have a sensible interpretation for competing risks?
23. Which of the following characteristics are the most important in determining a good measure?
24. An instrument designed to measure a Patient-Reported Outcome (PRO) demonstrates validity when:
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?
None of the above
The respondent’s mood at the time of the survey is irrelevant The respondent may be influenced by social desirability Measurement error is not a concern
A blood pressure reading is an example a. b. c. d. True False a. b. True False a. b. True False a. b.
Quantitative techniques are used to find common themes Focus of testing is mainly on the response options
Participant characteristics should reflect the general population Participants start to lose focus after about an hour
a. b. c. d.
Survey data
Administrative billing data Disease Registry
Demographic data from a randomized trial a.
b. c. d.
To study geographic variation in service delivery To study the impact of a rare disease
To study the impact of a new health care policy a.
b. c.
26. Which of the following is TRUE about self-report measures?
27. Factual data are objectively verifiable.
28. Respondents tend to give more agreeable answers when self-responding versus giving answers to an
interviewer.
29. Broad survey questions tend to work better than specific ones.
30. Which of the following is TRUE about cognitive testing?
31. Which of the following is an example of “secondary data?”
All of the above d.
Missing data Lack of clinical detail Subject misclassification All of the above
a. b. c. d.
The diagnosis or identification of a subject’s condition or problem The nature and purpose of the proposed treatment or intervention
The foreseeable risks and benefits of the proposed treatment or intervention All of the above
a. b. c. d. True False a. b.
A written consent form with a disclaimer Understanding written information The signature of the participant
Disclosure of information, Understanding, Voluntary choice, and Authorization a.
b. c. d.
Sample size and study design Costs and budget
Informed consent
Amount of compensation to participants a.
b. c. d.
Establishing a contract between the subject and the researcher
Monitoring the subject’s welfare and protecting confidentiality of information a.
b.
33. Use of secondary data is limited by which of the following?
34. Disclosure of which of the following items is necessary for an informed consent document?
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.
36. Most guidelines, codes and regulations for ethical research include a requirement for informed consent. The
process of informed consent includes the following elements:
37. Scientific validity is an important aspect of an ethical study. Assessing scientific validity includes
consideration of:
38. In the proposed ethical framework for clinical research, the final principle “respect for enrolled subjects” is
understood to include:
Keeping the financial costs of participation reasonable
Informing the subject of new information only after the study is published c. d. True False a. b. True False a. b.
The Study Sponsor
The Institutional Review Board The Date Safety Monitoring Board a.
b. c.
Monitor protocol compliance Monitor enrollment
Monitor adverse events All of the above Answers a and c only a.
b. c. d. e.
The individual must understand the study
The individual must have the disease being studied The individual must agree that the study is important The individual must make a voluntary decision to enroll A & D a. b. c. d. e. True False a. b.
39. If you are conducting clinical research that is funded by the NIH, you are always required to follow the
Common Rule:
40. Planned interim data analyses that require analysis of unblinded data need to be specified in the study
protocol.
41. If the Data Safety Monitoring Board makes a recommendation to terminate a study, the ultimate decision to
end the study lies with
42. Which of the following are responsibilities of the Data Safety Monitoring Board?
43. Which of the following are requirements for informed consent for clinical research (choose all that apply):
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.
True False a. b.
Pathology report
A handwritten daily diary such as a pain log maintained by the patient Nurse’s notes in the medical record
A worksheet that has a patient’s height and weight abstracted or taken from data in the medical record. a. b. c. d. True False a. b.
Collects relevant data in accordance with the protocol
Allows for efficient and complete data processing and analysis Facilitates the pooling of data across studies
All of the above a.
b. c. d.
Provide consistent units of measure to ensure comparable values Include multiple open ended questions with free-text responses Provide choices to questions to allow for efficient summarization Avoid collecting the same data in different parts of the CRF a. b. c. d. True False a. b.
The conceptualization and design of the research project The execution of the experiments
Writing of the paper a.
b. c. d.
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:
46. Which of the following is NOT an example of a source document?
47. An event that prolongs a hospitalization for a patient in a clinical trial is considered a serious adverse event:
48. What describes a properly designed Case Report Form (CRF)?
49. When collecting key data on the Case Report Form (CRF) for analysis, all of the following are true, EXCEPT:
50. It is the research nurse’s responsibility to determine whether an adverse event is related to the medical
treatment of procedure.
Assumption of responsibility for the entire study All of the above
d. e.
In your manuscript copying verbatim a paragraph from another scientist’s published manuscript with no attribution Submitting a previously published table of data without attribution to the original work
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
a. b. c. d. True False a. b.
United States legal requirement applicable to all NIH-supported investigators Ethical principle of justice
Responses to clinical interventions may differ between males and females and/or different racial and ethnic groups All of the above
a. b. c. d.
Knowledge has been gained about differences in cardiovascular symptoms between men and women
More research participants from minority groups have participated in clinical research, particularly in Phase III clinical trials
More women than men have participated in clinical research All of the above
a. b. c. d. True False a. b.
Two adequate and well-controlled trials 3 peer-reviewed journal articles Pre-specified end-points Clinical benefit a. b. c. d.
52. Which of these is NOT considered to be research misconduct?
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.
54. What is the reason NIH requires the inclusion of women and minorities in all clinical research?
55. Since the implementation of the NIH inclusion policy:
56. Experimental design is concerned with reducing and controlling variability in ways which make statistical
theory applicable to decisions about nature.
Study Data Tabulation Model (SDTM) Analysis Data Model (ADaM)
Clinical Data Awesomeness (CDA)
Clinical Data Acquisition Standards Harmonization (CDASH) Operational Data Model (ODM)
a. b. c. d. e. True False a. b.
To assure all patient protection measures are followed To ensure protocol adherence
To find and correct errors To ensure study results are valid All of the above
a. b. c. d. e.
Regulatory binder to include copies of current Clinical Laboratory Improvement Amendment (CLIA) certificates for all labs used by patients on a study
Copy of the signed informed consent is located in the patient’s medical record All eligibility criteria are met prior to patient enrollment on study
Documentation in the patient’s medical record of study drug administration including dose, route, missed doses, modified doses
a. b. c. d.
Required by law and to try to find new investigators Required by law and to check on the use of grant money
Required by law and to ensure that subjects’ rights are protected a. b. c. Amendment a. b.
58. Clinical Data Interchange Standards Consortium (CDISC) End-to-End Standards do NOT include:
59. “Real World Data” sources include claims databases, social media, electronic health records, patient
registries, randomized controlled trials, and smart phones.
60. Which of the following is/are reasons to perform audits as part of your organization’s Quality Assurance
Programs?
61. All of the following are examples of what auditors/monitors look for during the audit process EXCEPT:
62. Why do sponsors conduct monitoring visits?
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?
Site Evaluation Audit Inspection b. c. d. Web of Science Scopus Embase Biosis Micromedex a. b. c. d. e.
The invention being patented must work significantly better than the prior versions
To get worldwide patent protection, you will have to file a patent application in each and every country Patenting research tools is illegal
Nothing involving DNA can be patented
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
a. b. c. d. e.
A general description of the information to be disclosed by each party
The disclosing party’s duty to mark each document having confidential information, “CONFIDENTIAL” The disclosing party’s rights in future inventions made by the receiving party
Ground rules for how publication of research results will be enabled while preserving confidentiality of the original information
How long the recipient’s duty to maintain confidentiality will last a.
b. c. d. e.
Whether and how an evidence-based intervention that is known to be efficacious can be implemented in a “real-world” setting
Whether an intervention is efficacious in a highly selected sample of research participants Whether a treatment can be implemented in a highly selected sample of research participants
Whether and how an intervention that does not have known efficacy can be implemented in a controlled setting a.
b. c. d.
a.
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?
65. Which of the following five statements is TRUE about patents?
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):
67. Implementation studies focus primarily on:
68. Differences in health outcomes among different demographic groups are the result the complex interaction
of several factors, including:
Cultural and racial/ethnic identity
Socioeconomic and occupational trajectory Biology
Health care
Environment and geography All of the above
b. c. d. e. f.
Need and appropriateness of recommended treatment Health outcomes
Racial/ethnic group beliefs influencing decision making Comorbidities
All of the above a.
b. c. d. e.
The effort of the coordinator and Principal Investigator (PI) The procedures that will be done by another department The overhead of your organization
All of the above None of the above a.
b. c. d. e.
Pre-certify each patients insurance coverage as it pertains to research participation
State clearly in the informed consent what items will be paid for by the study budget, and what items will be the patients responsibility
Set up in advance of enrollment a way to capture study patients in the billing system to prevent double billing All of the above
None of the above a.
b. c. d. e.
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
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
This means that a reporter can quote you directly, using your name and title a.
b. c.
69. A racial/ethnic difference in health care use can be considered a disparity after the following factors have
been evaluated:
70. When preparing a budget for a clinical trial, what should you consider?
71. To protect the liability of your patient and your organization, what can you do?
72. When talking to a reporter it is important to be aware of terms of the journalistic trade. What does "On the
Record” mean?
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
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
This means that a reporter can quote you directly, using your name and title a.
b. c.
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
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
This means that a reporter can quote you directly, using your name and title a.
b. c.
On the record
Not for attribution and on background Off the record
a. b. c.
Minutes of NIH Institution Review Boards Your computer files
Document drafts Your e-mail messages Approved research protocols All of the above
a. b. c. d. e. f. True False a. b.
“Sure, I can talk with you right now. What would you like to talk about?” “I’d be happy to talk with you, but I am not allowed”
“I’d be happy to talk with you. Would you coordinate this with my Communication Office?” a.
b. c.
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?
74. When talking to a reporter it is important to be aware of terms of the journalistic trade. What does "Off the
Record" mean?
75. Despite the ground rules, when talking to a reporter it is always best to be?
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?
77. Under the United States’ Freedom of Information Act a document stamped "Confidential" may still be
released to the requester
Practice-based research networks (PBRNs) Community-based participatory research (CBPR) Community-oriented primary care (COPC) All of the above
a. b. c. d.
Make certain to only tell one community leader about the purpose of your engagement and research effort
Only spend time in the community once you have prepared your research protocol for review by community leaders Be clear about the purposes or goals of the community engagement effort, and the populations and/or communities you want to engage
Only commit to the community engagement for the short term (as long as funding remains available) a.
b. c. d.
Provide clear instructions so that the study procedures can be carried out the same way with all participants Provide detailed instructions for training new staff if there is turn over
Improve the likelihood of reproducibility of the trial results by providing detailed documentation of how the trial was conducted
All of the above a.
b. c. d.
Clinical research grants are assigned to study sections with inappropriate scientific expertise
Clinical research grants are harder to design well and the Principal Investigator may give up rather than revise and resubmit his/her application
Clinical research grants have higher requested budgets and do not do as well during review All of the above
None of the above a.
b. c. d. e.
The Scientific Review Group constitutes the first level of review The Advisory Council constitutes the second level of review The Scientific Review Group makes funding decisions A and B
A, B, and C are all true a.
b. c. d. e.
79. Which of the following are examples of engagement approaches to conducting clinical research studies in
community settings?
80. Which of the following is an important principle of community engagement for community-based
participatory research?
81. What is the purpose of having a detailed protocol for each clinical trial?
82. Overall NIH success rates for clinical research grants are lower than success rates for basic research grants
because:
The NIH Scoring Scale goes from 1 to 9
There are five ”core” review criteria: Significance, Investigator, Innovation, Approach, Environment The Overall Impact Score is determined by averaging the subscores for the five “core” review criteria Appropriateness of the Budget does not affect the Overall Impact Score
The Review Group can defer the review of an application if they need more information to score it a.
b. c. d. e.
Understanding the psychology of the review process Beginning the submission process early
Performing a critical self-assessment
Examination of currently funded research in the area All of the above
a. b. c. d. e.
