NIH Principles and Practices of Clinical Research

Research misconduct does NOT include honest error or difference of opinion.

True

Statistical specificity is the probability of having a negative test if the person does not have the illness.

True

With an intention-to-treat analysis, the benefits of randomization are significantly strengthened.

True

Association is frequently confused with causality because it is frequently difficult to isolate association from causality.

?

Which of the following is NOT an object of routine monitoring visits?

?

Regarding the four major types of intellectual property, which of the following statements is TRUE?

A valid trademark lives for as long as the owner actually uses it in commerce.

Which of the following is NOT an example of a source document?

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?

All of the above

Differences in health outcomes among different demographic groups are the result of the complex interaction of several factors, including:

All of the above: Cultural and racial/ethnic identity Socioeconomic and occupational trajectory Biology Healthcare Environment and geography

The principal investigator of a clinical trial is responsible for:

All of the above: The eligibility of enrolled patients Adverse event reporting Timely reporting of data

With regard to risks to subjects from participating in research, which of the following is/are true:

All of ze above

An h-index is a way to:

An indicator of a researcher's lifetime impact in his or her field

Investigators' responsibilities do NOT include:

Auditing of trial

What benefits should an IRB consider when deciding whether a study is acceptable?

Benefits to participants and to society from the knowledge learned

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

A research participant's decision to participate in research is "voluntary" according to the US federal regulations if it is free from:

C - coercion or undue influence

Most guidelines, codes and regulations for ethical research include a requirement for informed consent. The process of informed consent includes the following elements:

Disclosure of information, understanding, voluntary choice, and authorization

Which of the following groups is a type of randomized study?

Double-blind placebo control study

Imhotep

Egyptian, first physician figure to rise out of antiquity; known scribe, priest, architect, astronomer and magician. performed surgery, practiced some dentistry, extracted medicine from plants and knew the position and function of vital organs.

T or F: Excluded research is a type of research that is subject to the U.S. rules for the protection of research subjects.

F?

For an individual patient being treated for an off-label indication with an FDA-approved product, an IND is required.

False

True or False: 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.

False

It is important to be able to replicate the randomization results, i.e., reproduce the string of treatment assignments.

False?

Hippocrates

Father of modern medicine; Hipprocratic oath --> high moral standards.

Which of the following is FALSE regarding differences between clinicaltrials.gov results reporting and journal publication?

I put c - Journals publish all submitted manuscripts

Researcher personnel costs are always charged the same regardless of the type of sponsor?

I put false

The most egregious ethical violation in the Public Health Services' Tuskegee syphilis study was that:

The participants were kept from seeking treatment for their syphilis

Epidemiology assumes disease has causal and preventative factors that can be identified through systematic investigation.

True

In a clinical trial, the larger the expected difference in treatment arms, the smaller the number of study subjects required.

True

One strategy to increase the likelihood of getting a statistically significant result is to increase the sample size to a large number.

True

Which of the following four statements is TRUE about patents?

To get worldwide patent protection, you will have to file a patent application in each and every country.

If you are conducting clinical research that is funded by the NIH, you are always required to follow the Common Rule

True.

True or False: Planned interim data analyses, that require analysis of unblinded data, need to be specified in the study protocol.

True?

Implementation studies focus primarily on:

Whether and how an evidence-based intervention that is known to be efficacious can be implemented in a "real-world" setting

Clinical trial registration is important so that:

a) existing trials are publicly available; b) Trials are made publicly available even if they are not finished

A potential barrier to recruitment in clinical trials is/are:

all of the above

The basic formulas for sample size use which of the following:

all of the above

When preparing a budget for a clinical trial, what should you consider?

all of the above

Which of the following are examples of what auditors look for during the audit process:

all of the above - 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

Which of the following design strategies are used in dissemination and implementation research?

all of the above: Randomized controlled trials Natural experiments Simulations and modeling designs A and B

Which of the following are responsibilities of the Data Safety Monitoring Board?

all of the above; Monitor protocol compliance Monitor enrollment Monitor adverse events

Authorship is based on significant contribution to:

all of ze above

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:

all the above?

Coffee was reported to cause lung cancer until it was noted that coffee drinkers also smoked. This is an example of:

confounding!

What is reliability?

consistency of measurement

Passive immunization was first used to treat:

diphtheria

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?

embase

Scientific misconduct includes all of the following EXCEPT:

human error

Scientific validity is:

measures what it's supposed to measure. The ability of a study to correctly answer the research question

The purpose of a phase 1 study is:

safety and dose ranging

Scientific validity is an important aspect of an ethical study. Assessing scientific validity includes consideration of:

sample size and study design

The first clinical trial

scurvy

What is validity?

the degree to which a test measures what it says it measures. the peabody test said it measured intelligence. however, it only tests receptive vocabulary, so that's not valid.

What does failing to reject H0 (the null hypothesis) mean?

there is not enough evidence in the sample to reject the null hypothesis.