4/14/201620152016 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. a. True b. False https://ippcr.nihtraining.com/test.php 1/15 4/14/2016 20152016 Test 7. For balancing between-participant variance b. the better. The main purpose(s) of establishing exclusionary criteria is/are: a. B and C only 8. For safety issues c. Randomizing each patient to a treatment with a known probability 10. True b. Using the last digit of the medical record number c. It keeps treatment allocation free from selection bias b. a. It allows us to attribute differences in outcomes to differences in efficacy of the treatments under study (causality) c. it is recommended to use site as a stratification variable. Varying block size while using block randomization d. False 11.nihtraining. What are reasons for carefully considering selection of participants in a research study: a.com/test. If gender is a stratification variable in a randomized controlled trial. All of the above e. we expect: a. In multi-site trials. Using stratified randomization by clinical site b. True b.php 2/15 . Both a and b d. None of the above 13. The characteristics of your study participants could help determine your ability to generalize findings b. To decrease potential confounding d. and as many men as women in Treatment T2 https://ippcr. Which of the following is NOT a legitimate way to randomize? a. It may impact outcomes of your study d. The more stratification variables. Randomization is important because: a. False 12. It could impact feasibility of your study c. a. As many men as women in Treatment T1. All of the above 9. It can help clarify your question and study design e. of zero difference). True b. What can change a study's power and how is power impacted? a. True b. In order to define the survival outcome variable we do NOT need to define which of the following? a. Variance d. False 17. Difference (effect) to be detected (δ): power increases as this difference increases. If the 95% confidence interval does not include the value of the null hypothesis (e. Both (a) and (b) d. The basic formulas for sample size use which of the following: a. As many men in Treatment T1 as in Treatment T2. What does failing to reject H0 (the null hypothesis) mean? a. True b.g. Power is the probability of detecting an effect when it actually exists. Type I error b. a. The time origin https://ippcr.4/14/2016 20152016 Test b. The event b. Variation in outcome (σ2): power decreases as an outcome’s variance increases d. There is not enough evidence in your sample to reject the null hypothesis b.php 3/15 . the result is statistically significant at the 5% alpha level. False 18. All of the above 20. a. a. Neither (a) nor (b) 14. The p-value is the probability that the null hypothesis (H0) is true. Type II error c. and as many women in Treatment T1 as in Treatment T2 c.nihtraining.com/test. False 16. Difference (effect) to be detected e. All of the above 19. Sample size (n): power increases as sample size increases b. The null hypothesis is true 15. c. Newer measures of Patient-Reported Outcomes (PROs) are being developed using a statistical approach known as Item Response Theory (IRT). any type of Cox regression. Cost and categorization b. The instrument contains more than two items 25. depending on the study design there are other statistical analysis methods that may be appropriate 22. Items are easier for people to understand d. Kaplan Meier. Yes b. The Cox proportional hazards model is the best method to use for time-to-event analyses. There are Cox models that do not assume proportional hazards. The statistical methods section states stratified logrank tests were performed to compare overall survival between groups. Any and all items can be administered to obtain a valid score b. Cox models can be used to analyze the study data. Measures developed with IRT cost less to develop c. c. Feasibility and frequency of publication c. The instrument measures what it is supposed to measure (and nothing else) d. Research participants understand the items in the same way as the measure developers b.php 4/15 . The figures include several Kaplan-Meier curves and reports the p-values from the logrank tests. The time at which an event occurs 21. Reliability and validity 24. You can always assume proportional hazards. No 23. The proportional hazards assumption should be evaluated because it may not be true.com/test. The covariates e. Patients whose health condition is stable will receive the same score after repeated administrations of the measure c.nihtraining. For consistent unbiased estimates the Cox model requires independent censoring. Does the Kaplan Meier have a sensible interpretation for competing risks? a. logistic regression. Also. either directly or given the covariates in the model. You are reviewing a manuscript with the results of an observational study that looked at survival for several groups. Cox models can be used to make inference about continuous and categorical covariates such as age and gender in time-to-event models. What other statistical analysis method could you recommend be used before making conclusions about the study results? a. The time scale d. Which of the following is one of the benefits of measures developed using IRT? a. The answer is always the same regardless of the statistical analysis method. The manuscript does not mention any other statistical methods. An instrument designed to measure a Patient-Reported Outcome (PRO) demonstrates validity when: a. it does not matter which type of analysis is used to evaluate the time-to-event or survival data b. https://ippcr. Which of the following characteristics are the most important in determining a good measure? a.4/14/2016 20152016 Test c. Scale and specialization d. Quantitative techniques are used to find common themes b. False 30. The respondent’s mood at the time of the survey is irrelevant b. Administrative billing data c. A blood pressure reading is an example 27. Secondary data are useful for which of the following reasons? a.nihtraining. To study geographic variation in service delivery b.4/14/2016 20152016 Test None of the above 26. True b. Which of the following is TRUE about cognitive testing? a. Which of the following is an example of “secondary data?” a. Demographic data from a randomized trial 32. To study the impact of a new health care policy https://ippcr.com/test. True b. Factual data are objectively verifiable. Participants start to lose focus after about an hour 31. False 29. The respondent may be influenced by social desirability c. a. True b. Which of the following is TRUE about self-report measures? a. False 28. To study the impact of a rare disease c. Survey data b.php 5/15 . a. Measurement error is not a concern d. Disease Registry d. Respondents tend to give more agreeable answers when self-responding versus giving answers to an interviewer. Participant characteristics should reflect the general population d. Focus of testing is mainly on the response options c. a. Broad survey questions tend to work better than specific ones. A written consent form with a disclaimer b. False 36. Most guidelines. Understanding written information c. All of the above 33. Disclosure of information. Informed consent d. The process of informed consent includes the following elements: a. Understanding. Amount of compensation to participants 38. All of the above 34. In the proposed ethical framework for clinical research.4/14/2016 20152016 Test d. The nature and purpose of the proposed treatment or intervention c. True b. Missing data b. Use of secondary data is limited by which of the following? a. Voluntary choice. 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. and Authorization 37. Monitoring the subject’s welfare and protecting confidentiality of information https://ippcr. The foreseeable risks and benefits of the proposed treatment or intervention d. Lack of clinical detail c. All of the above 35. codes and regulations for ethical research include a requirement for informed consent. also known as a DPA. Costs and budget c. Subject misclassification d.com/test. the final principle “respect for enrolled subjects” is understood to include: a. Disclosure of which of the following items is necessary for an informed consent document? a. Scientific validity is an important aspect of an ethical study.nihtraining. The signature of the participant d. Sample size and study design b. a. The diagnosis or identification of a subject’s condition or problem b. Establishing a contract between the subject and the researcher b. Assessing scientific validity includes consideration of: a.php 6/15 . you are always required to follow the Common Rule: a. The Institutional Review Board c. A&D 44. Monitor protocol compliance b. provide effective tools for evaluating whether individuals can give informed consent for clinical research. True b. All of the above e. The individual must have the disease being studied c. False 41.nihtraining.com/test. Keeping the financial costs of participation reasonable d. The individual must agree that the study is important d. the ultimate decision to end the study lies with a. False https://ippcr. Monitor enrollment c. The individual must understand the study b.php 7/15 . Planned interim data analyses that require analysis of unblinded data need to be specified in the study protocol. True b. Informing the subject of new information only after the study is published 39. a. If the Data Safety Monitoring Board makes a recommendation to terminate a study. Tests of general cognitive function. The individual must make a voluntary decision to enroll e.4/14/2016 20152016 Test c. False 40. such as IQ tests and mini-mental status exams (MMSE). If you are conducting clinical research that is funded by the NIH. Which of the following are responsibilities of the Data Safety Monitoring Board? a. a. The Date Safety Monitoring Board 42. Monitor adverse events d. Which of the following are requirements for informed consent for clinical research (choose all that apply): a. True b. The Study Sponsor b. Answers a and c only 43. Avoid collecting the same data in different parts of the CRF 50. Provide choices to questions to allow for efficient summarization d. The execution of the experiments c. a. False 51. all of the following are true. Which of the following is NOT an example of a source document? a. True b. 47. Authorship is based on significant contribution to: a. An event that prolongs a hospitalization for a patient in a clinical trial is considered a serious adverse event: a. A handwritten daily diary such as a pain log maintained by the patient c. The conceptualization and design of the research project b. All of the above 49.nihtraining. EXCEPT: a. Provide consistent units of measure to ensure comparable values b. Pathology report b. Allows for efficient and complete data processing and analysis c.php 8/15 . Facilitates the pooling of data across studies d. When collecting key data on the Case Report Form (CRF) for analysis. Writing of the paper d. False 48. 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.4/14/2016 20152016 Test 45. True b. Include multiple open ended questions with free-text responses c. False 46. 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. What describes a properly designed Case Report Form (CRF)? a. https://ippcr. Collects relevant data in accordance with the protocol b.com/test. It is the research nurse’s responsibility to determine whether an adverse event is related to the medical treatment of procedure. a. True b. All of the above 56. United States legal requirement applicable to all NIH-supported investigators b. Which of these is NOT considered to be research misconduct? a. a.com/test. Preparing a figure for a paper using only those experiments which had laboratory controls that worked d. 20152016 Test Assumption of responsibility for the entire study All of the above 52. The United States Food and Drug Administration's "Gold Standard" for approval does NOT include: a. Two adequate and well-controlled trials b. True b. What is the reason NIH requires the inclusion of women and minorities in all clinical research? a. All of the above 55. More women than men have participated in clinical research d. Knowledge has been gained about differences in cardiovascular symptoms between men and women b. breakthrough therapy designation. False 54. particularly in Phase III clinical trials c. Changing some of the numbers in a table so that the standard error is smaller 53.nihtraining. Ethical principle of justice c.4/14/2016 d. Since the implementation of the NIH inclusion policy: a. accelerated approval. e. Clinical benefit https://ippcr. Submitting a previously published table of data without attribution to the original work c. Experimental design is concerned with reducing and controlling variability in ways which make statistical theory applicable to decisions about nature. False 57.php 9/15 . Pre-specified end-points d. 3 peer-reviewed journal articles c. and priority review designation. The expedited programs that the United States Food and Drug Administration (FDA) can use to facilitate drug development and approval are: fast track designation. More research participants from minority groups have participated in clinical research. Responses to clinical interventions may differ between males and females and/or different racial and ethnic groups d. In your manuscript copying verbatim a paragraph from another scientist’s published manuscript with no attribution b. route. Study Data Tabulation Model (SDTM) b. Clinical Data Acquisition Standards Harmonization (CDASH) e. To find and correct errors d. social media.com/test. patient registries. Good Clinical Practice (GCP). All of the above 61. To ensure study results are valid e. 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. Documentation in the patient’s medical record of study drug administration including dose. and accurately reported according to the protocol. Copy of the signed informed consent is located in the patient’s medical record c. modified doses 62. Which of the following is/are reasons to perform audits as part of your organization’s Quality Assurance Programs? a.nihtraining. Regulatory binder to include copies of current Clinical Laboratory Improvement Amendment (CLIA) certificates for all labs used by patients on a study b. and smart phones. Required by law and to ensure that subjects’ rights are protected 63. a. Analysis Data Model (ADaM) c. Clinical Data Awesomeness (CDA) d. Operational Data Model (ODM) 59. To ensure protocol adherence c. “Real World Data” sources include claims databases.4/14/2016 20152016 Test 58. Amendment b. Standard Operating Procedures (SOP).php 10/15 . randomized controlled trials. Clinical Data Interchange Standards Consortium (CDISC) End-to-End Standards do NOT include: a. https://ippcr. False 60. analyzed. electronic health records. All of the following are examples of what auditors/monitors look for during the audit process EXCEPT: a. Why do sponsors conduct monitoring visits? a. All eligibility criteria are met prior to patient enrollment on study d. missed doses. To assure all patient protection measures are followed b. Required by law and to try to find new investigators b. and the applicable regulatory requirements? a. True b. Required by law and to check on the use of grant money c. Embase d. Patenting research tools is illegal d. Nothing involving DNA can be patented e. toxicology. Whether and how an evidence-based intervention that is known to be efficacious can be implemented in a “realworld” setting b. The disclosing party’s duty to mark each document having confidential information. Whether a treatment can be implemented in a highly selected sample of research participants d. Implementation studies focus primarily on: a. you will have to file a patent application in each and every country c. A typical "Confidential Disclosure Agreement" normally includes all but one of the following items (in other words. 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. 20152016 Test Site Evaluation c. and is particularly valuable for drug. conference and international information coverage? a.php 11/15 . A general description of the information to be disclosed by each party b. Which of the following is a key clinical information database that is very similar in subject coverage to PubMed. The disclosing party’s rights in future inventions made by the receiving party d. Audit d. Differences in health outcomes among different demographic groups are the result the complex interaction of several factors. Web of Science b. Micromedex 65. “CONFIDENTIAL” c. How long the recipient’s duty to maintain confidentiality will last 67. Which of the following five statements is TRUE about patents? a. Biosis e.nihtraining. https://ippcr. select the one that is NOT normally there): a. Whether and how an intervention that does not have known efficacy can be implemented in a controlled setting 68. Inspection 64.4/14/2016 b. To get worldwide patent protection. including: a. Whether an intervention is efficacious in a highly selected sample of research participants c. Ground rules for how publication of research results will be enabled while preserving confidentiality of the original information e. Scopus c. The invention being patented must work significantly better than the prior versions b.com/test. Health outcomes c. Set up in advance of enrollment a way to capture study patients in the billing system to prevent double billing d. the reporter can use it in other ways such as getting another source to respond to your comment b. what should you consider? a. What does “not for 12/15 . Biology d. This means that the reporter can use the information you give.php it is important to be aware of terms of the journalistic trade. Pre-certify each patients insurance coverage as it pertains to research participation b. To protect the liability of your patient and your organization. but you are not to be named. The overhead of your organization d. Environment and geography f. or a knowledgeable NIH source c. What does "On the Record” mean? a. and what items will be the patients responsibility c. All of the above e. using your name and title 73. When talking to a reporter it is important to be aware of terms of the journalistic trade. Health care e. what can you do? a. All of the above 69. The effort of the coordinator and Principal Investigator (PI) b. including direct quotes. State clearly in the informed consent what items will be paid for by the study budget. Need and appropriateness of recommended treatment b. When talking to a reporter https://ippcr. however. Comorbidities e. None of the above 72.com/test. When preparing a budget for a clinical trial.4/14/2016 20152016 Test Cultural and racial/ethnic identity b. Socioeconomic and occupational trajectory c. A racial/ethnic difference in health care use can be considered a disparity after the following factors have been evaluated: a. None of the above 71. The procedures that will be done by another department c. Racial/ethnic group beliefs influencing decision making d. This means that a reporter cannot use your information in a story as coming from you. All of the above e. All of the above 70.nihtraining. This means that a reporter can quote you directly. You may be identified as a NIH scientist. This means that the reporter can use the information you give. “I’d be happy to talk with you. Your e-mail messages e. when talking to a reporter it is always best to be? a. The United States’ Freedom of Information Act (FOIA) provides individuals with a right to access records in the possession of the federal government. Approved research protocols f. The best response for you to give when a reporter contacts you directly is? a. When talking to a reporter it is important to be aware of terms of the journalistic trade. This means that a reporter can quote you directly. however. but I am not allowed” c. This means that a reporter can quote you directly.nihtraining. Under the United States’ Freedom of Information Act a document stamped "Confidential" may still be released to the requester a. What does "Off the Record" mean? a. This means that the reporter can use the information you give. the reporter can use it in others ways such as getting another source to respond to your comment b. Your computer files c.com/test. False 78.php 13/15 . using your name and title 74. True b. “Sure. You may be identified as a NIH scientist. Would you coordinate this with my Communication Office?” https://ippcr. including direct quotes. This means that a reporter cannot use your information in a story as coming from you. You may be identified as a NIH scientist or a knowledgeable NIH source c. however. On the record b. but you are not to be named. I can talk with you right now. Off the record 76. the reporter can use it in other ways such as getting another source to respond to your comment b. but you are not to be named. This means that the a reporter cannot use your information in a story as coming from you.4/14/2016 20152016 Test 73. or a knowledgeable NIH source c. What would you like to talk about?” b. What does “not for attribution and on background” mean? a. “I’d be happy to talk with you. Document drafts d. Which item best describes what may be available under the FOIA? a. All of the above 77. using your name and title 75. When talking to a reporter it is important to be aware of terms of the journalistic trade. Minutes of NIH Institution Review Boards b. Despite the ground rules. including direct quotes. Not for attribution and on background c. Only commit to the community engagement for the short term (as long as funding remains available) 81. All of the above e. B. Practice-based research networks (PBRNs) b.com/test. Provide detailed instructions for training new staff if there is turn over c. Be clear about the purposes or goals of the community engagement effort. Make certain to only tell one community leader about the purpose of your engagement and research effort b. and C are all true https://ippcr. The Scientific Review Group makes funding decisions d. What is the purpose of having a detailed protocol for each clinical trial? a.php 14/15 . Clinical research grants are harder to design well and the Principal Investigator may give up rather than revise and resubmit his/her application c. None of the above 83. Provide clear instructions so that the study procedures can be carried out the same way with all participants b. Community-oriented primary care (COPC) d. All of the above 82. Only spend time in the community once you have prepared your research protocol for review by community leaders c. A and B e. Community-based participatory research (CBPR) c. Improve the likelihood of reproducibility of the trial results by providing detailed documentation of how the trial was conducted d. Clinical research grants have higher requested budgets and do not do as well during review d.4/14/2016 20152016 Test 79. Overall NIH success rates for clinical research grants are lower than success rates for basic research grants because: a. Which of the following statement(s) about the NIH Dual Review System is TRUE? a. Which of the following is an important principle of community engagement for community-based participatory research? a.nihtraining. The Advisory Council constitutes the second level of review c. and the populations and/or communities you want to engage d. A. Which of the following are examples of engagement approaches to conducting clinical research studies in community settings? a. The Scientific Review Group constitutes the first level of review b. Clinical research grants are assigned to study sections with inappropriate scientific expertise b. All of the above 80. Approach.4/14/2016 20152016 Test 84. Performing a critical self-assessment d. Understanding the psychology of the review process b. All of the above Finalize Test https://ippcr. Appropriateness of the Budget does not affect the Overall Impact Score e. The Overall Impact Score is determined by averaging the subscores for the five “core” review criteria d. A successful NIH grant submission include(s): a. There are five ”core” review criteria: Significance. The NIH Scoring Scale goes from 1 to 9 b. Which of the following statements about the NIH first level of review is FALSE? a. Investigator. The Review Group can defer the review of an application if they need more information to score it 85. Examination of currently funded research in the area e.nihtraining.com/test.php 15/15 . Beginning the submission process early c. Environment c. Innovation.