NIH IPPCR - 2020-21
With an intention-to-treat analysis, the benefits of randomization are significantly strengthened.
True
For an individual patient being treated for an off-label indication with an FDA-approved product, an IND is NOT required.
***True False
A research participant's decision to participate in research is "voluntary" according to the US federal regulations if it is free from:
****Coercion or undue influence Payment or other incentives Cognitive impairment
Coffee was reported to cause lung cancer until it was noted that coffee drinkers also smoked. This is an example of:
***Confounding Poor study design Reliability Validity
The NIH Library of Medicine hosts the clinicaltrials.gov website, which is mandated by:
***FDA Journal policy for publication IND registration All of the above
What is validity?
***How well you measure the construct you had in mind. How well you measure the correlation. The manner in which you measure a construct.
John Snow is the father of ______ for work in tracing the source of a cholera outbreak.
***Modern epidemiology Infectious disease Genetics Hematology
What can change a study's power and how power is impacted?
***Sample size (n): power decreases as sample size increases Difference (effect) to be detected (δ): power increases as the difference decreases. Variation in outcome (σ2): power decreases as an outcome's variance increases
Scientific validity is an important aspect of an ethical study. Assessing scientific validity includes consideration of:
***Sample size and study design Costs and budget Informed consent Amount of compensation to participants
Planned interim data analyses, that require analysis of unblinded data, need to be specified in the study protocol.
***T F
What is reliability
***The consistency in a measure The size of the operation definition
NIH-funded clinical research studies conducted in foreign countries are required to comply with the inclusion policy.
***True False
Power is the probability of detecting an effect when it actually exists.
***True False
The FDA can put a clinical hold on a Phase 1 IND study if the proposed IND study will not be able to assess safety.
***True False
The best way to implement randomization is by using a computer application or an online tool.
***True False
Epidemiology assumes disease has causal and preventative factors that can be identified through systematic investigation.
***Yes No
It is the research nurse's responsibility to determine whether an adverse event is related to the medical treatment of procedure.
True ***False
Scientific misconduct includes all of the following EXCEPT:
Fabrication Plagiarism Falsification ***Human Error
Researcher personnel costs vary with the type of sponsor.
True ***False
What does failing to reject H0 (the null hypothesis) mean?
***There is not enough evidence in your sample to reject the null hypothesis. The null hypothesis is true.
An event that prolongs a hospitalization for a patient in a clinical trial is considered a serious adverse event:
***True False
Association is frequently confused with causality because it is frequently difficult to isolate association from causality.
***True False
Excluded research is a type of research that is subject to the U.S. rules for the protection of research subjects.
***True False
Differences in health outcomes among different demographic groups are the result of the complex interaction of several factors, including:
A - cultural and racial/ethnic identity B- Socioeconomic and occupational trajectory C- Biology D- Healthcare E- Environment and geography F- All of the Above ***G - A, B, and E
Assuming similar access to healthcare services (including screening and vaccinations), differences in incidence, prevalence and/or severity of a disease between two populations may reflect:
A biological vulnerability that has not been well identified, and for which different screening or treatment is needed Influence of cultural perspectives on healthcare seeking behavior Differences in the interaction between biological and non-biological factors on health outcomes between the two populations Differences in disease presentation between the two populations ***All of the above A and C
Regarding the four major types of intellectual property, which of the following statements is TRUE?
A trade secret is any secret that the owner claims is a trade secret. ***A valid trademark lives for as long as the owner actually uses it in commerce. An invention is patentable only if it is significant enough to be worth of peer-reviewed publication. To get a copyright in a new work, the author must first register it with the government. The only thing one can do with a patent is sue other people for infringement.
Most guidelines, codes and regulations for ethical research include a requirement for informed consent. The process of informed consent includes the following elements:
A written consent form with a disclaimer Understanding written information The signature of the participant ***Disclosure of information, understanding, voluntary choice, and authorization
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?
Amendment Site initiation visit ***Audit Routine monitoring visit
Granted similar access to healthcare services (including screening and vaccinations), differences in health outcomes (e.g., remission, relapse, post-surgical complications) associated with disease X between two populations may reflect:
Biological vulnerabilities that have not been well identified Influence of cultural perspectives on health and healthcare seeking behavior Healthcare provider biases during screening/treatment decision-making Need for evidence-based guidelines of diagnosis and treatment ***All of the above A, B, and D
A study using a historical control arm:
Can be problematic because of changes in clinical care Can be problematic because of changes in diagnostic criteria ***A and B
Boundaries between research and practice are important because:
Clinical research is designed to contribute to general knowledge. Clinical practice is designed to improve the health of an individual. Clinical research is designed to contribute to general knowledge. ***A and B
What describes a properly designed Case Report Form (CRF)
Collects relevant data in accordance with the protocol Allows for efficient data in accordance with the protocol Facilitates the pooling of data across studies **All of the above
Which of the following statements about control groups or control arms in a study is FALSE?
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 arm.
In the proposed ethical framework for clinical research, the final principle "respect for enrolled subjects" is understood to include:
Establishing a contract between the subject and the researcher ***Monitoring the subject's welfare and protecting confidentiality of information Keeping the financial costs of participation reasonable Informing the subject of new information only after the study is published
Clinical trial registration is important so that:
Existing trials are publicly available Trials are made publicly available even if they are not finished Pre-specified outcome measures are known Clinical trial data can be combined across several trials All of the above ***A and B only
With regard to risks to subjects from participating in research, which of the following is/are true:
If appropriate, procedures should be used that are already being performed on the subjects for diagnostic or treatment purposes. Research procedures should be used that are consistent with sound research design. Research procedures should not expose subjects to risks that exceed the benefits the subjects will receive from participating in the research. ***All of the above
Since the implementation of the NIH inclusion policy:
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 A and B ***All of the above
Scientific misconduct can cause which of the following?
Make other scientists upset because they have spent time and resources to replicate manipulated data Damage to institutional reputations Undermine public perception of truthfulness of science Loss of government financial support Jail time All of the above
The first clinical trial studied treatments for:
Malaria Anemia ***Scurvy Sepsis
Which of the following are responsibilities of the Data Safety Monitoring Board?
Monitor protocol compliance Monitor enrollment Monitor adverse events ***All of the above
Scientific validity is:
Not a requirement of all research ***The ability of a study to correctly answer the research question Providing no patient benefit while causing harm Not related to ethics
Which of the following is NOT an example of a source document?
Pathology report A signed and dated 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.
What is the purpose of having a detailed protocol for each clinical trial?
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 turnover Improve the likelihood of reproducibility of the trial results by providing detailed documentation of how the trial was conducted ***aAll of the above
Which of the following design strategies are used in dissemination and implementation research?
Randomized controlled trials Natural experiments Simulations and modeling designs A and B ***All of the above
Which of the following are examples of what auditors look for during the audit process:
Regulatory binder to include copies of current Clinical Laboratory Improvement Amendment (CLIA) certificates for all labs used by patients on a study 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 ***All of the above
Which of the following is most likely a case series study?
Report of 5 cases of pneumocytosis 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 case control study is a type of interventional experimental study.
T ***F
Research misconduct includes honest error or difference of opinion.
T ***F
Authorship is based on significant contribution to:
The conceptualization and design of the research project The execution of the experiments Writing of the paper Assumption of responsibility for the entire study ***All of the above
When preparing a budget for a clinical trial, what should you consider?
The effort of the coordinator and Principal Investigator (PI) The procedures that will be done by another department The overhead rate your organization charges ***All of the above None of the above
Which of the following four statements is TRUE about patents?
The invention being patented must work significantly better that 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. A non-confidential disclosure of your invention before any patent application has been filed will not jeopardize patent rights (e.g. if you only tell your friends).
The most egregious ethical violation in the Public Health Services' Tuskegee syphilis study was that:
The participants were injected with syphilis
If you are conducting clinical research that is funded by the NIH, you are always required to follow the Common Rule
True
Which of the following is/are reasons to perform audits as part of your organization's Quality Assurance Programs?
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
Tests of general cognitive function, such as IQ tests and mini-mental status exams (MMSE), provide effective tools for determining whether individuals can give informed consent for a clinical trial.
True ***False
The basic formulas for sample size use which of the following:
Type I error Type II error Variance Difference (effect) to be detected ****All of the above
What is/are the reason(s) that NIH requires the inclusion of women and minorities in all clinical research?
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 and B only
An h-index is a way to:
Verify that correct biostatistical tools are used Check the comprehensiveness of retrieval of a given search strategy ****Measure an author's productivity and impact Analyze the level of education required to understand a given text passage Determine the ratio of search results that are accessible to people with disabilities
Which of the following is a key clinical database that is most similar to PubMed in subject coverage, and is particularly valuable for drug, toxicology, conference, and international information coverage?
Web of Science Scopus ***Embase Biosis Micromedex
Implementation studies focus primarily on:
Whether a treatment can be implemented in a highly selected sample of research participants Whether an intervention is efficacious in a highly selected sample of research participants ***Whether and how an evidence-based intervention that is known to be efficacious can be implemented in a "real-world" setting Whether and how an intervention that does not have known efficacy can be implemented in a controlled setting