Solved by a verified expert: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 expertiseb. Clinical research grants are harder to design well and the Principal Investigator may give up rather than revise and resubmit their applicationc. Clinical research grants have higher requested budgets and do not do as well during reviewd. All of the abovee. None of the above2. Which of the following statement(s) about the NIH Dual Review System is TRUE?a. The Scientific Review Group constitutes the first level of reviewb. The Advisory Council constitutes the second level of reviewc. The Scientific Review Group makes funding decisionsd. a and be. a, b, and c are all true3. Which of the following statements about the first level of review is FALSE?a. The NIH Scoring Scale goes from 1 to 9b. There are five “core” review criteria: Significance, Investigator, Innovation, Approach, Environmentc. The Overall Impact Score is determined by averaging the sub scores for the five “core” review criteriad. Appropriateness of the Budget does not affect the Overall Impact Scoree. The Review Group can defer the review of an application if they need more information to score it4. A successful grant submission include(s):a. Understanding the psychology of the review processb. Beginning the submission process earlyc. Performing a critical self-assessmentd. Examination of currently funded research in the areae. All of the above5. Which of the following is NOT an example of a source document?a. Pathology reportb. A handwritten daily diary maintained by the patientc. Nurse’s notes in the medical recordd. 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. Trueb. False7. What best describes a properly designed Case Report Form (CRF)?a. Collects relevant data in accordance with the protocolb. Allows for efficient and complete data processing and analysisc. Facilitates the pooling of data across studiesd. All of the above8. 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 valuesb. Include multiple open ended questions with free-textual responsesc. Provide choices to questions to allow for efficient summarizationd. Avoid collecting the same data in different parts of the CRF9. It is the research nurse’s responsibility to determine whether an adverse event is related to the medical treatment of procedure?a. Trueb. False10. 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 departmentc. The overhead of your organizationd. All of the abovee. None of the above11. 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 participationb. State clearly in the informed consent what items will be paid for by the study budget, and what items will be the patients responsibilityc. Set up in advance of enrollment a way to capture study patients in the billing system to prevent double billingd. All of the abovee. None of the above12. What does double dipping refer to?a. An ice cream cone dipped in chocolate twiceb. Placing both feet in the pool at the same timec. Having the cost of a research procedure covered in the study budget, and also billing the patient’s insuranced. All of the abovee. None of the above13. Epidemiology assumes disease has causal and preventative factors that can be identified through systematic investigation.a. Yesb. No14. Which of the following is most likely a case series studya. Report of 5 cases of pneumocystis pneumonia in previously healthy homosexual menb. National survey of health and nutritionc. Association study of maternal use of stilbesterol with tumor appearanced. Observational study of cardiovascular health in men and women over 6515. Which of the following statements about control groups or control arms in a study is FALSEa. Control groups can take many different formsb. The specific question being addressed in the study directs the choice of the control group or groups for the studyc. All good studies have a placebo control armd. A randomized study’s control group should be an ethical option for study participants16. Mark the TRUE statement about Blinding/Maskinga. All of these statements are trueb. 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 studya. Group sequential trialb. Historical control studyc. Cohort studyd. Case-control study18. Which item(s) below are motivations and features of randomizationa. Helps reduce selection bias when allocating participants to study armsb. In double blind studies helps eliminate patient response biasc. Attribute causalityd. Try to ensure only one factor is different between two or more groupse. All of the above19. Which of the following is NOT a legitimate way to randomizea. Using stratified randomization by clinical centerb. Using the last digit of the medical record numberc. Varying block size while using blocked randomizationd. Randomizing each patient to a treatment with a known probability20. What does failing to reject Ho (the null hypothesis) mean?a. There is not enough evidence in your sample to reject the null hypothesisb. The null hypothesis is truec. The deviation from the null might be too small to detect reliably with the study’s sample sized. a and c21. 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 trueb. The p-value is a measure of the strength of evidence in the study’s data that the null hypothesis is not true22. What is the positive predictive value?a. The probability of testing positive if truly diseased; does not depend on disease prevalence in the populationb. The probability of being diseased given a positive test result; depends on disease prevalence in the populationc. The probability of being diseased given a positive test result; does not depend on disease prevalence in the populationd. A statistic regularly used in the analysis of both cohort and case-control study designs23. 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. 100b. 200c. 400d. Cannot be determined – one needs to know the common standard deviation of the measurese. Can be determined, but one needs special power tables to calculate24. The basic formulas for sample size use which of the followinga. Type I errorb. Type II errorc. Varianced. Difference (effect) to be detectede. All of the above25. What can change a study’s power and how is power impacteda. Sample size (n): power increases as sample size increasesb. Difference (effect) to be detected (?): power increases as this difference increases.c. Variation in outcome (?2): power decreases as an outcome’s variance increasesd. All of the above26. In order to define the survival outcome variable we do NOT need to define which of the following?a. The eventb. The time originc. The time scaled. The covariatese. The time at which an event occurs27. 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 datab. The Cox proportional hazards model is the best method to use for time-to-event analyses. You can always assume proportional hazardsc. 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 appropriate28. Does the Kaplan Meier have a sensible interpretation for competing risks?a. Yesb. No29. 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 commentb. 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 sourcec. This means that a reporter can quote you directly, using your name and title30. 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 commentb. 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 sourcec. This means that a reporter can quote you directly, using your name and title31. 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 commentb. 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 sourcec. This means that a reporter can quote you directly, using your name and title32. Despite the ground rules, when talking to a reporter it is always best to be?a. On the recordb. Not for attribution and on backgroundc. Off the record33. 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 Boardsb. Your computer filesc. Document draftsd. Your e-mail messagese. Approved research protocolsf. All of the above34. Under the United States’ Freedom of Information Act a document stamped “Confidential” may still be released to the requestera. Trueb. False35. 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 db. Sensitivity to changec. Ratio scaled. Depression37. Which of the following characteristics are the most important in determining a good measure?a. Cost and categorizationb. Feasibility and frequency of publicationc. Scale and specializationd. Reliability and validity38. Community-Based Participatory Research (CBPR) is only applicable to descriptive research to identify the social determinants of health.a. Trueb. False39. CBPR is only qualitative research methods used to study community health problems.a. Trueb. False40. 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 reauthorizationb. NIH policyc. Ethical principle of justiced. All of the above41. Since the implementation of the inclusion policy:a. Knowledge has been gained about differences in cardiovascular symptoms between men and womenb. More research participants from minority groups have participated in clinical researchc. More women than men have participated in clinical researchd. All of the above42. 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 convenientb. 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 Companyc. The scientist and the colleague should personally execute a Confidential Disclosure Agreement before discussing the compoundd. The colleague, on behalf of the company, must file an Employee Invention Report on the scientist’s compound as quickly as possiblee. The parties must negotiate a full Cooperative Research and Development Agreement (CRADA) to allow the company to pay for the scientist’s efforts43. 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 outb. 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 anythingd. File an Employee Invention Report on the compound as quickly as possible, and attach any relevant background materialse. 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-execution44. 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 opportunityb. Buy stock in the colleague’s company before the invention has been publicly disclosedc. Sign a Uniform Biological Material Transfer Agreement immediately to document the transfer rightsd. Forward the draft to the NIH scientist’s Technology Development Coordinator to determine what the NIH wants to do about the inventione. Do nothing – under a CRADA, the company automatically owns all inventions and NIH no longer has to worry about such inventions45. 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 specialtya. 1 & 2b. 1 & 4c. 2 & 3d. 2 & 4e. 2 & 546. 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 Scienceb. Scopusc. Embased. Biosise. Micromedex47. Implementation studies focus primarily on:a. Whether and how an intervention that is known to be efficacious can be implemented in a “real-world” settingb. Whether an intervention is efficacious in a highly selected samples of research participantsc. Whether a treatment can be implemented in a highly selected sample of research participantsd. Whether and how an intervention that does not have known efficacy can be implemented in a controlled setting48. The main purpose(s) of establishing exclusionary criteria is:a. For balancing between-participant varianceb. For safety issuesc. To decrease potential confoundingd. All of the abovee. b and c only49. The risk of Type I error is most likely to occur when:a. A researcher has designed a study to maximize control over extraneous factorsb. A researcher is most concerned about various sources of biasc. A researcher is most concerned with maximizing generalizabilityd. A researcher has designed a study to equally balance internal and external validity50. 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 teamb. Matrix modelc. Disconnected teamd. Clinical team51. 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 managementb. The project manager serves as both a project leader and analystc. The project manager may have duties in managing the company’s pipeline portfoliod. Interpersonal skills may be as important to the project manager than analytical skills52. 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 problemb. The nature and purpose of the proposed treatment or interventionc. The foreseeable risks and benefits of the proposed treatment or interventiond. All of the above53. 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. Trueb. False54. Authorship is based on significant contribution to?a. The conceptualization and design of the research projectb. The execution of the experimentsc. Writing of the paperd. Assumption of responsibility for the entire studye. Any of the above55. 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 attributionb. Submitting a previously published table of data without attribution to the original workc. Preparing a figure for a paper using only those experiments which had laboratory controls that workedd. Changing some of the numbers in a table so that the standard error is smaller56. 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 designb. Costs and budgetc. Informed consentd. Amount of compensation to participants57. 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 researcherb. Monitoring the subject’s welfare and protecting confidentiality of informationc. Keeping the financial costs of participation reasonabled. Informing the subject of new information only after the study is published58. If you are conducting clinical research that is funded by the NIH, you are always required to follow the:a. CIOMS International Guidelinesb. Common Rulec. Nuremberg Coded. Belmont Report
Recent Comments