evaluation of unanticipated adverse device effects (uades) must be reported to the fda by the:

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Answer 1

Evaluation of unanticipated adverse device effects (UADDEs) must be reported to the FDA by the IRB and all investigators participating in the test of the product within ten working days.

What is IRB and FDA?

The full meaning of IRB is Institutional Review Board, while the full meaning of FDA is the United States Food and Drugs Administration - a Federal Agency.

The above bodies are responsible for protecting American citizens from harmful products.

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Related Questions

The ocean to the east of Russia is the __________ Ocean

Answers

Explanation:

because of it's large size,

the ocean to the east of Russia is the “Moscow” ocean!

Each stage in erikson's theory presents a crisis that must be resolved. these crises are multiple choice developmental turning points with enhanced potentials. developmental turning points with both increased vulnerability and enhanced potentials. catastrophic events that toughen the individual for future crises. developmental turning points with increased vulnerability.

Answers

According to Erikson, the crises in stages that must be resolved are developmental turning points with both increased vulnerability and enhanced potentials.

What did Erikson's theory say?

In Erikson's Theory of Development, there are 8 stages that a human must pass through from birth to old age.

Each of these stages will present the human with a crisis and these crises need to be resolved because they hold great potential as turning points in the person's development.

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A student conducted a research project in which fake smoke entered the waiting area used by participants. This procedure was used to create a stressful situation and the student then tested participants' performance on complex reasoning tasks. One student waiting in a wheelchair experienced a panic attack when the smoke appeared. After this incident, the IRB stopped the research. This example demonstrates that

Answers

The fact that the person in a wheelchair suffered a panic attack showed that b. characteristics of individuals must be considered when determining risk.

Why did the IRB stop the research?

When introducing a stressful situation for research, it is important that the risk to the participants are assessed.

This risk should be based on each participant's individual characteristics because humans react differently to the same stimulus. The researcher here failed to do this and so the research was stopped.

Options include:
a. Risk assessment should only be carried out when a person in a wheelchair is involved.

b. characteristics of individuals must be considered when determining risk.

c. characteristics of group must be considered when determining risk.

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4. Considering the topic in this unit of economic systems, analyze how different economic systems handle natural disaster situations. The United States is a mixed economy, largely a market economy with some features of socialism (there are very few " pure" economies for each type of economic system.) How would a drought be handled in a more socialist economy and a command economy and what would cause those distinctions?
20POINTS!!!

Answers

What causes the distinctions between the way nations deal with natural disaster situations are the ideas of the prevailing economic systems.

What are economic systems?

These are the principles of managing the economy in relation to its development, allocation of resources, state intervention and solution of scarcity problems, for example. In the capitalist system, for example, the focus is on profitability through private property, which has greater freedom due to less state intervention.

Therefore, each government will deal with a different natural disaster, for example, allocating resources according to its established economic system and developing strategies to reduce the impact on people's lives.

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Read the excerpt from "Opening Ceremonies of the New York and Brooklyn Bridge" by Hon. Seth Low, Mayor of the City of Brooklyn.

Fourteen times the earth has made its great march through the heavens since the work began. The vicissitudes of fourteen years have tried the courage and the faith of engineers and of people. At last we all rejoice in the signal triumph. The beautiful and stately structure fulfills the fondest hope. It will be a source of pleasure to-day to every citizen that no other name is associated with the end than that which has directed the work from the beginning--the name of Roebling. With all my heart I give to him who bears it now the city's acknowledgment and thanks.

What is the central idea of this excerpt?

Low explains that it took Roebling fourteen years to design and build the Brooklyn Bridge.
Low celebrates the completion of the Brooklyn Bridge and the hard work that went into building it.
Low takes credit for managing the planning and construction of the Brooklyn Bridge.
Low complains that the construction of the Brooklyn Bridge took much longer than it should have.

Answers

Answer:

Low celebrates the completion of the Brooklyn Bridge and the hard work that went into building it.

Explanation:

According to the details in this excerpt, the people from Manhattan and Brooklyn will no longer lose opportunities due to limited methods of crossing the river.

Question 4
The Majority Leader is elected by the political party with the most Senators.
A) True
B) False

Answers

The answer should be a

Answer:

A) True

Explanation:

The Majority Leader has to be elected by their political party.

The Chinese frustrated the Europeans because the Chinese wanted little to do with European goods.

Answers

Answer:

True!

Explanation:

Yes, the Chinese frustrated the Europeans because the Chinese wanted little - nothing - to do with European goods. They simply didn't like Europeans - they thought they were barbarians who were worst than the Manchurians and the Mongolians who were also barbarians in the eyes of the Chinese.

Hope this helps!

- profparis

Answer:

TRUE!

Explanation:

Yeah It’s True Becuase  Chinese wanted little to do with European goods

The Chinese frustrated the Europeans because the Chinese wanted little to do with European goods. Though the Dutch were able to seize Taiwan in 1624, the Chinese were able to drive them out just two years later. European traders impressed the Chinese government, who held them in high regard

The author recommends a. more lacings. c. thicker boots. b. fewer lacings. d. frequent changes of clothing. Please select the best answer from the choices provided A B C D

Answers

Answer:

B. Fewer lacings

Explanation:

^^^

What is a natural resource? Give at least 2 examples.

Answers

2 examplesNatural resources are materials from the Earth that are used to support life and meet people's needs. Any natural substance that humans use can be considered a natural resource. Oil, coal, natural gas, metals, stone and sand are natural resources. Other natural resources are air, sunlight, soil and water.

What is a natural resource?

Resources like air water sunlight mineral forest and wildlife are provided to us By Nature they are called natural Resources

Classification -:

natural resource can be classified on the basis of their nature stock distribution and label development on the basis of their nature natural resource may be biotic or abiotic the biotic resource are living things such as useful plant and animal the avoiding resources and non living things such as water air solar energy soil and metal

the future of our planet and its people now depend on our ability to maintain and preserve and the life support system which nature has provided us it is therefore our first foremost Duty to :

minimise the damage to natural environment by change in consumption pattern improve quality of human life through interaction among all the nation make effort to utilise renewable resource education communities to protect and care for their environment adopt a strategy of economic growth that is environment friendly and conserve the diversity of Earth

Describe a situation that you have thought to be unfair or unjust, whether towards yourself or towards others. How did you address the situation, if at all?.

Answers

Essay writing is given to students in order to test their writing, reading skills and knowledge of a topic.

How to write an essay?

Based on the information given, the way to write the essay will be given. Firstly, it's important to decide on your topic. In this case, you're to describe a situation that you have thought to be unfair towards yourself or towards others.

Research should be done on the topic and create an essay outline. Set your argument in the introduction and develop it with evidence.

Finally, check the content, grammar, formatting, and spelling, of your essay.

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What is the name of the smallest ball in bocce ball?.

Answers

Answer:

The smallest ball called the pallino is the target.

Explanation:

Hope this helps and have a good day!

After the adoption in 1791 of the ten amendments that constitute the bill of rights, how many times had the constitution’s drafters changed the original document?.

Answers

The constitution drafters changed the Original document 17 times.

What is Constitution?

Constitution refers to the document drafted by the government of the nation which includes all the rules and regulation to be followed by all the citizens of the nation.

The adoption in 1791 included several amendments such as the the Bills of right, as well as the important amendment regarding the Amendment of the original document of the constitution.  

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Malaysia enjoys monopoly on rubber. But which type of monopoly is this:
A.Implied monopoly
B.Legal monopoly
C.Social monopoly
D.Natural monopoly

Answers

Answer:

Natural Monopoly I hope I helped you have a nice day

Visit five or more public places and assess the non-accessibility or accessibility for
the following people:
a. A person without arms
b. A person in a wheelchair
c. A blind person
d. Another disability of your choice
Determine whether or not these people would be able to enter the public
building on their own and whether or not they could use the restroom without
assistance. What difficulties might arise?

Answers

The following public places and their non-accessibility or accessibility for the following people are provided below.

What is the non-accessibility or accessibility of these public places for the following people?Public places are assessed for their accessibility and non-accessibility for the following people. a. A person without arms For a person without arms, a public place like a subway station or supermarket can be slightly exclusionary if they do not have enough mechanisms in place to help people without arms. Any public place that relies on the use of hands can be cumbersome and non-accessible. b. A person in a wheelchair Public places without an elevated ramp can be marked high in non-accessibility in the context of accommodating people in a wheelchair. c. A blind personAn example of a public place that is high in non-accessibility for a blind person can be a movie theatre. d. Another disability of your choiceIn this case, people who suffer from deafness can find public transportation that relies on auditory announcements high in non-accessibility and low in accessibility. In all of the above-mentioned disabilities, except for cases c. and d., some difficulty might arise in entering a public building or accessing the restroom.

Therefore, the accessibility and non-accessibility of public places for the mentioned people have been provided above.

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What is one aspect about the US Supreme Court you would keep

Answers

Some aspects about the Supreme Court you could keep us the justices like Samuel alito and so on of like the Chief Justice Robert’s

Family members, primarily women, often perform a valuable function in keeping other family members informed about the well-being of other family members. this creating, maintaining and monitoring function informs other family members when others need emotional and physical support. this has come to be known in the academic literature as ________.

Answers

The contributions that women provide to the family are endless. In the academic literature, this has come to be known as "kinkeeping."

What is family members?

A group of individuals who interact with one another in their separate social roles, typically those of spouses, parents, children, and siblings, and who are bound together by marriage, blood ties, or adoption, are referred to as "family members."

Compared to other family members, women in the family play important roles. She takes care of household duties like meal preparation and serving, clothes choosing and maintenance, and home furnishing. In the scholarly literature, this has come to be known as "kinkeeping."

As a result, kinkeeping is the correct answer.

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It became apparent to Sergio that regardless of the type of group he found himself engaged in, he always assumed the leadership position. He began to consider which personal characteristics predisposed him to become the leader. He identified the fact that he was a tall, good-looking guy with a good disposition and high intelligence. He decided that these characteristics made him a leader. Which approach to leadership most accurately describes Sergio's belief about his leadership

Answers

The approach to leadership that most accurately describes Sergio's belief about his leadership skills is Charismatic Leadership.

What is the Charismatic Leadership style?

The charismatic leadership style is grounded on the following foundations:

Personal charmCommunication skillsPersuasivenessConfidenceCreativityInspirationIdealized influence

The charismatic leadership style creates an emotional appeal with great social impact.

Thus, the approach to leadership that most accurately describes Sergio's belief about his leadership skills is Charismatic Leadership.

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William will be presenting his midyear paper in front of the class. His classmates are talking as they come into class and take their seats. When William's teacher says something to him, he tries to focus on what she is saying while tuning out the other voices. Analyzing this example using a Gestalt perceptual principle, the noisy environment is an example of _____ and his teacher's voice is an example of _____.

Answers

Analyzing this example using a Gestalt perceptual principle, the noisy environment is an example of ground and his teacher's voice is an example of figure.

Ground and figure in Gestalt principle

According to the Gestalt perceptual principle, we can select what to focus on in a way that makes it seem that things, people, or other stimuli are in the background or in the foreground.

In the case described in the question, William is focusing on the teacher's voice, which means he perceives it as the figure or the foreground. On the other hand, William is tuning out the noisy environment, which means he perceives it as the background or simply ground.

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The region of Eastern Europe is located north of the __________ Sea?

Answers

Answer:

The region of Eastern Europe is located North of the Caspian Sea.

the most effective drug treatment for obsessive-compulsive disorder involves the administration of Quizlet

Answers

The correct option is D. After an infection, autoimmune-related damage to the brain is believed to be the cause of the obsessive-compulsive disorder symptoms that develop.

What is obsessive-compulsive disorder?

A person with obsessive-compulsive disorder (OCD) frequently experiences recurring, uncontrollable thoughts and/or behaviors that they feel the need to repeat.

Thus, both can be used for treatment there is a minor difference between them one has received 254 ratings, with an overall rating of 7.9 out of 10. 75% of reviewers noted a favorable effect, while 14% noted a detrimental effect. On the other hand, a total of 2007 ratings has resulted in an average rating of 7.3 out of 10.

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. One of the following is agent of the formation of Igneous rocks A. Wave and Ice C. Weathering and Erosion D. Glacier and Wind B. Heat and Pressure ​

Answers

Answer:

b

Explanation:

because its the only correct one

Who were the Roundheads?

Answers

In the English Civil War, there were two competing factions: the Royalists, who supported the monarch as the supreme authority, and the Parliamentarians, who supported the legislature. When the Parliament was in place, the monarch had the last say and could either adopt or reject laws. The royalists were known as Cavilers, while the parlimentary force was known as the round heads. Oliver Cromwell, the commander of the Roundheads and a Puritan, revolutionized military strategy with his "New Model Army," which ultimately defeated the primarily upper class royalists who were using antiquated strategies to win the war. King Charles was deposed at the end of the conflict, and England remained without a monarch until Cromwell's death. Then, once the monarchy was restored by Parliament, Cromwell's body was unearthed and executed by hanging, drawing, and quartering.

The Attachment Caption:

This well-known painting, titled "When Did You Last See Your Father," depicts men in armor sat around a table asking the son of a royalist where his father is. You can clearly observe the extreme contrast between the clothing worn by each group: the expensive velvets of the youngster and his female relatives desperately hoping he won't give anything away, against auster for the roundheads.

You respond to a scene in which nearby containers of hazardous materials have come open and appear to be leaking. you should:

Answers

When you respond to a scene in which nearby containers of hazardous materials have come open and appear to be leaking, you should:

Maintain a minimum safe distance from the materials.

What are Hazardous Materials?

Hazardous materials are substances that pose the risk of danger to human life. Fuels like petrol, gas, and kerosene in transit can be hazardous when the vessel containing them begins to leak.

So, when responding to such emergency cases, it is wise that a reasonable distance is maintained.

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Which memory test would most effectively reveal that mr. quintano, age, 55, still remembers many of his high school classmates?

Answers

The memory test that could be taken to show that Mr. Quitano still remembers his high school classmates is the Recognition test.

What is the recognition test?

It is a test that was developed in the late 20th century to evaluate the recognition level of the memories of people aged 18 - 70.

This test can therefore be used on Mr. Quintano to test how many people he remembers from high school because it will show how much his memories can recognize his previous classmates.

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Sociologists would argue that a change in the economy would eventually result in a change in the family. this is because:

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family relationships can suffer extreme hardships due to a poor economy, which can lead to a strained family dynamic. Family’s may also decide to not have as many children, due to lack of financial stability.

The form of government started in Rome. The form of government started in Rome .

A. Republic or people controlled

B. Socialism or government
controlling the economy

C. Monarchy or ruled by a king

D. Dictator or absolute rule by one person ​

Answers

The answer is most likely A.

Help please

Explain how the culture of today and that of the 1890s are connected through music.

Answers

Answer:

The 1890s saw a surge of musical transformation. Lyrics began to be more personal and poetic. Less of telling a story through song, music also became more lively.

Explanation:

Las vegas has a museum for what ""sin city"" staple?.

Answers

Answer:

Neon signs

Explanation:

Cocktails

Neon signs

Slot machines

Money

What does the graph show about the importance of clean air?

People have a lower risk of dying from COPD when compared to acute lower respiratory infections.
The health risk is the highest for getting lung cancer when people are exposed to indoor air pollution.
Most people will die from the negative health effects associated with stroke as indoor dirty air builds up.
The risk of developing acute lower respiratory infection and ischemic heart disease is the same when exposed to indoor air pollution.

Answers

The importance of clean air Is that Most people will die from the negative health effects associated with stroke as indoor dirty air builds up.

What is the importance of the Clean Air Act of 1990?

This is known to be a United States federal law that was set up to help aid or protect human health and the environment from the negative effect of air pollution.

Therefore, The importance of clean air Is that Most people will die from the negative health effects associated with stroke as indoor dirty air builds up.

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A motorboat is powered by a motor greater than 25 horsepower. Which persons must have a Boating Safety Education Certificate in their possession to operate the boat legally

Answers

All PWC (personal watercraft) drivers are required to have completed and retained a boating safety education course. A boat with more than 25 horsepower or a PWC may NOT be operated by anyone under the age of 11 years old.

What are the criteria to operate a boat with greater than 25 horsepower?

Personal Watercraft (PWC):

Even with an adult on board, anyone under the age of 13 is not allowed to drive.13-year-olds operating a watercraft must either a) have someone older than 21 with them, b) have a watercraft operator's permit, and c) be under the direct supervision of someone older than 21.14–17 years old: Requires either a) a watercraft operator's permit or b) a passenger who is at least 21.

Motorboat Operators:

Less than 12 years old: a) under 25 HP, no limit; b) between 25 and 75 HP, someone at least 21 must be on board and within reach of the controls; c) over 75 HP, not even with adults on board, is prohibited.12 to 17-year-olds: a) 25 HP or less - no limit; b) over 25 HP - require a watercraft operator's permit or have a person at least 21 years old on board within reach of the controls.

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Which of the following choices is not included in Ralph Waldo Emerson's description of success?wealthself respectrespect earned from others around youappreciation for others Per capita GDP is Group of answer choices A dollar measure of the economic growth rate of a country. The value of the factors of production used to produce output in a country. The sum of consumer goods, investment goods, government services, and net exports. None of the Answers are Correct. GDP divided by total population. What is the best way to describe the current groups represented by labor unions?A. In current times, the majority of unions represent government workers.B. In current times, the majority of unions represent manufacturing (factory) workers. C. In current times, the majority of unions represent agricultural ( farm) workers. D. In the current times, the majority of unions represent white (office) collar workers find the least common denominator 3/2x+4 and -11/3x+6 Which of the following was NOT a precursor to the Revolutionary War?a. Quartering Actb. Boston Tea Partyc. Royal Proclamation of 1763d. War Hawk Congress Which trig expression can be used to find the height on the tree where the top guy wire attaches if the base of the wire is four feet from the base? Have trending public opinion gotten better or worse what is the measure of this angle Question 1(Multiple Choice Worth 4 points)Which set of line segments could create a right triangle?O24, 30, 35O 12, 18, 30.O 18, 24, 30O 18, 24, 35 The Pythagorean Identity states that: (sin x)^2 + (cos x)2 = 1Given sin 0 = 2/5, find cos 0.cos 0 = ?/? The purpose of __________ is to create real or perceived product differences. Group of answer choices niche marketing product differentiation product mixing target marketing What is the measurement of m? 24 6 Explain the impact of health care costs at the national, state, and individual levels. how did wwi impact brazil simplify (3+5)(3+2) in the great gatsby Which aspect of the women is most affected by the imagery ofweightlessness? An object moving at a constant velocity will always have anegative displacementnegative accelerationzero accelerationzero displacement If the balloon had a volume of 3 L at a depth of 50 m, what was the original volume of the balloon it we assume the pressure at the surface of the water is 14.7 psi? Express your answer using one significant figure and include the appropriate units. Active235810With which statement would the speaker of "Money to Us Is of No Value" most likely agree?O. The US government should buy land for people.O Money will become important to future generations.O Peace can be obtained if an agreement over land can be made.OIt is necessary to share government land with other tribes. A graduated cylinder is filled to 12.5 mLwith water and a piece of tin is placedin the cylinder, displacing the level to16.8 mL.What is the volume of the tin piece incubic centimeters?[?] cmRecord your answer to the tenths place.Volume (cm)