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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? 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, b, and c are all true 3, biology papers help. Which of the following statements about the first level of review is FALSE?
The Biology papers help Scoring Scale goes from 1 to 9 b, biology papers help. 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 biology papers help include s : a.
Understanding the psychology of the review process b. Beginning the submission process early biology papers help. Performing a critical self-assessment d. Examination of currently funded research in the area e.
All of the above 5. Which of the biology papers help is NOT an example of a source document? Pathology report b. A handwritten daily diary maintained by the patient c. An event that prolongs a hospitalization is considered a serious adverse event: a, biology papers help.
True b. False 7. What best describes a properly designed Case Report Form CRF? Collects relevant data in accordance with the protocol b, biology papers help. 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 biology papers help 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. False When preparing a budget for a clinical trial, what should you consider? The effort of the coordinator and Principal Investigator PI b, biology papers help.
The procedures that will be done by another department c. The overhead of your organization d. None of the above To protect the liability of your patient and your organization, what can you do? Pre-certify each patients insurance coverage as it pertains to research participation b, biology papers help. State clearly in the informed consent what items will be paid for by the biology papers help 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.
What does double dipping refer to? An ice cream cone dipped in chocolate twice b. Placing both feet in the pool at the same time c. Epidemiology assumes disease has causal and preventative factors that can be identified through systematic investigation. Yes b. No Which of the following is most likely a case series study a, biology papers help. 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 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 biology papers help arm d. All of these statements are true b. A purpose of blinding or masking is to reduce the possibility of expectancy bias impacting study outcomes.
There are almost always biology papers help 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 biology papers help masked, why, to what information each person is masked, and the criteria for unmasking, biology papers help.
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 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 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 What does failing to reject Ho the null hypothesis mean? There is not enough evidence in your sample to biology papers help the null hypothesis b, biology papers help.
The null hypothesis is true c. a and c The null hypothesis for a study is the biology papers help 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?
The p-value is the probability that the null hypothesis is true b. What is the positive predictive value? 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 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.
Approximately how many patients in each treatment arm would be required in each treatment arm to detect a FIVE point difference?
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
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