1. Overall 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 their 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
2. 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
3. Which of the following statements about the 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 sub scores 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
4. A successful 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
5. Which of the following is NOT an example of a source document?
a.  Pathology report
b.  A handwritten daily diary maintained by the patient
c.  Nurse’s notes in the medical record
d.  A worksheet that has recorded a patient’s height and weight abstracted or taken from data in the medical record.
6. An event that prolongs a hospitalization is considered a serious adverse event:
a.  True
b.  False
7. What best 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
8. 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-textual responses
c.  Provide choices to questions to allow for efficient summarization
d.  Avoid collecting the same data in different parts of the CRF
9. 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
10. 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
11. 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
12. What does double dipping refer to?
a.  An ice cream cone dipped in chocolate twice
b.  Placing both feet in the pool at the same time
c.  Having the cost of a research procedure covered in the study budget, and also billing the patient’s insurance
d.  All of the above
e.  None of the above
13. Epidemiology assumes disease has causal and preventative factors that can be identified through systematic investigation.
a.  Yes
b.  No
14. 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
15. 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
d.  A randomized study’s control group should be an ethical option for study participants
16. Mark the TRUE statement about Blinding/Masking
a.  All of these statements are true
b.  A purpose of blinding or masking is to reduce the possibility of expectancy bias impacting study outcomes.
c.  There are almost always design features that can be implemented to at least partially mask a study.
d.  A few of the different labels applied to studies include double-blind, single-masked, assessor-masked, unmasked, or open-label.
e.  Protocols should clearly specify who is masked, why, to what information each person is masked, and the criteria for unmasking.
17. 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
18. Which item(s) below are motivations and features of randomization
a.  Helps reduce selection bias when allocating participants to study arms
b.  In double blind studies helps eliminate patient response bias
c.  Attribute causality
d.  Try to ensure only one factor is different between two or more groups
e.  All of the above
19. Which of the following is NOT a legitimate way to randomize
a.  Using stratified randomization by clinical center
b.  Using the last digit of the medical record number
c.  Varying block size while using blocked randomization
d.  Randomizing each patient to a treatment with a known probability
20. What does failing to reject Ho (the null hypothesis) mean?
a.  There is not enough evidence in your sample to reject the null hypothesis
b.  The null hypothesis is true
c.  The deviation from the null might be too small to detect reliably with the study’s sample size
d.  a and c
21. The null hypothesis for a study is the mean systolic blood pressure (SBP) in the control group is equal to (the same) as the mean systolic blood pressure in the experimental intervention group. Which one of the following statements is an accurate interpretation of the p-value that comes from testing this hypothesis?
a.  The p-value is the probability that the null hypothesis is true
b.  The p-value is a measure of the strength of evidence in the study’s data that the null hypothesis is not true
22. What is the positive predictive value?
a.  The probability of testing positive if truly diseased; does not depend on disease prevalence in the population
b.  The probability of being diseased given a positive test result; depends on disease prevalence in the population
c.  The probability of being diseased given a positive test result; does not depend on disease prevalence in the population
d.  A statistic regularly used in the analysis of both cohort and case-control study designs
23. Suppose a study comparing the effects of two treatments on systolic blood pressure requires approximately 50 patients in each treatment arm to statistically detect a TEN point difference (2-sided t-test at significance level of 0.05 and power of 80%). Approximately how many patients in each treatment arm would be required in each treatment arm to detect a FIVE point difference?
a.  100
b.  200
c.  400
d.  Cannot be determined – one needs to know the common standard deviation of the measures
e.  Can be determined, but one needs special power tables to calculate
24. 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
25. 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
26. 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
27. 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
28. Does the Kaplan Meier have a sensible interpretation for competing risks?
a.  Yes
b.  No
29. 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
30. 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
31. 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
32. 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
33. 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
34. Under the United States’ Freedom of Information Act a document stamped “Confidential” may still be released to the requester
a.  True
b.  False
35. 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?”
36. Which of the following is a key component of a good outcome measure?
a.  Cohen’s d
b.  Sensitivity to change
c.  Ratio scale
d.  Depression
37. 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
38. Community-Based Participatory Research (CBPR) is only applicable to descriptive research to identify the social determinants of health.
a.  True
b.  False
39. CBPR is only qualitative research methods used to study community health problems.
a.  True
b.  False
40. What is the reason NIH requires the inclusion of women and minorities in all clinical research?
a.  Legal requirement as a result of the 1993 NIH reauthorization
b.  NIH policy
c.  Ethical principle of justice
d.  All of the above
41. Since the implementation of the 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
c.  More women than men have participated in clinical research
d.  All of the above
42. A university scientist has discovered a compound that may be an important new drug, the compound has not yet been disclosed publicly, but a manuscript is being prepared. The scientist needs to conduct certain additional experiments, but is unfamiliar with the technical procedures. Fortunately, the scientist knows a colleague, now working at a company, who is an expert at those techniques. The scientist wants to send a sample to the colleague to conduct those tests on the compound. Which one of the following statements is TRUE?
a.  The scientist should send a sample of the compound to the colleague now; any necessary paperwork can be done later, when it is more convenient
b.  The scientist likely is not authorized to send a sample to the colleague until a Material Transfer Agreement has been executed by the scientist’s employer and the colleague’s Company
c.  The scientist and the colleague should personally execute a Confidential Disclosure Agreement before discussing the compound
d.  The colleague, on behalf of the company, must file an Employee Invention Report on the scientist’s compound as quickly as possible
e.  The parties must negotiate a full Cooperative Research and Development Agreement (CRADA) to allow the company to pay for the scientist’s efforts
43. A scientist at NIH wants to get a sample of a patented compound from a company. The company is willing to send the compound if the scientist signs a form. The form says that (1) the recipient may not distribute the materials further, (2) the company owns any inventions the recipient develops, and (3) the recipient agrees to indemnify the company. Which one of the following should the scientist do?
a.  Send the form to the NIH scientist’s Technology Transfer office or General Counsel’s office, and wait for them and the company’s attorneys to work something out
b.  The NIH scientist should sign the company’s form on behalf of the NIH and hope no one at the company realizes the scientist is not authorized to sign to sign the form.
c.  Get the sample from a colleague at a nearby university, who signed the company’s form, if the university colleague will not make the scientist sign anything
d.  File an Employee Invention Report on the compound as quickly as possible, and attach any relevant background materials
e.  Sign a copy of the US Public Health Service (PHS) Model Cooperative Research And Development Agreement (CRADA) and send it to the company for counter-execution
44. A scientist at NIH and a colleague at a company have been working together on a project established under an approved, duly executed CRADA. During the project, the colleague shows the NIH scientist a draft (unfiled) patent application for something the colleague and the NIH scientist both believe they co-invented. The scientist should do which of the following?
a.  Post the draft patent application on the Internet immediately, because NIH policy favors publication at the soonest possible opportunity
b.  Buy stock in the colleague’s company before the invention has been publicly disclosed
c.  Sign a Uniform Biological Material Transfer Agreement immediately to document the transfer rights
d.  Forward the draft to the NIH scientist’s Technology Development Coordinator to determine what the NIH wants to do about the invention
e.  Do nothing – under a CRADA, the company automatically owns all inventions and NIH no longer has to worry about such inventions
45. In order to strengthen certain literature searches for potential side effects, Johns Hopkins University recommended that investigators collaborate with which two of the following: 1) a board-certified physician with a relevant specialty 2) a pharmacist 3) a senior MD/PhD researcher with a relevant specialty 4) a librarian 5) a PhD chemist with a relevant specialty
a.  1 & 2
b.  1 & 4
c.  2 & 3
d.  2 & 4
e.  2 & 5
46. 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
47. Implementation studies focus primarily on:
a.  Whether and how an 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 samples 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
48. The main purpose(s) of establishing exclusionary criteria is:
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
49. The risk of Type I error is most likely to occur when:
a.  A researcher has designed a study to maximize control over extraneous factors
b.  A researcher is most concerned about various sources of bias
c.  A researcher is most concerned with maximizing generalizability
d.  A researcher has designed a study to equally balance internal and external validity
50. The name of the conceptual structure of a team made up of people of different disciplines who each report to someone outside the team structure is known as:
a.  Project team
b.  Matrix model
c.  Disconnected team
d.  Clinical team
51. Which is NOT true of the recent trends in project management?
a.  There is a trend toward the project manager being more involved in timeline management
b.  The project manager serves as both a project leader and analyst
c.  The project manager may have duties in managing the company’s pipeline portfolio
d.  Interpersonal skills may be as important to the project manager than analytical skills
52. 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
53. 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
54. 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.  Any of the above
55. 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
d.  Changing some of the numbers in a table so that the standard error is smaller
56. In evaluating the ethical aspects of a study, it is important to assess scientific validity. 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
57. 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
58. If you are conducting clinical research that is funded by the NIH, you are always required to follow the:
a.  CIOMS International Guidelines
b.  Common Rule
c.  Nuremberg Code
d.  Belmont Report