Before a significant risk medical mobile app (MMA) study can commence, what does the sponsor need to do

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Answer 1

Based on operational standards, before a significant risk medical mobile app (MMA) study can commence, the sponsor "must have an approved IDE from FDA."

What are IDE and FDA?

IDE is the acronym of Investigational Device Exemption. Approval of IDE validates the investigational device to be utilized in medical research to obtain safety and efficacy data.

Similarly, FDA is the acronym of Food and Drug Administration. The responsibility of the FDA is to ensure there is safety and security of human and veterinary commodities, including drugs, biological products, and medical devices, among others.

Hence, in this case, it is concluded that the correct answer is that the sponsor "must have an approved IDE from FDA."

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Related Questions

A partner's self-employment earnings (loss) may be affected by her share of ordinary business income (loss) and any guaranteed payments she receives. The impact of these amounts typically depends on the status of the partner. Which of the following statements correctly describes the effect these items have on the partner's self-employment earnings (loss)?A) General partner - only guaranteed payments affect self-employment earnings (loss).B) General partner - ordinary business income (loss) and guaranteed payments affect self-employment earnings (loss).C) Limited partner - only guaranteed payments affect self-employment earnings (loss).D) Limited partner - only ordinary business income (loss) affects self-employment income (loss).E) Both General partner - ordinary business income (loss) and guaranteed payments affect self-employment earnings (loss) and Limited partner - only guaranteed payments affect self-employment earnings (loss).

Answers

There are different form of partnership. The statements that correctly describes the effect these items have on the partner's self-employment earnings (loss) is given below;

Both General partner - ordinary business income (loss) and guaranteed payments affect self-employment earnings (loss) and Limited partner - only guaranteed payments affect self-employment earnings (loss).

A general partner is known to be a type of owner of a partnership and they are said to either be a managing partner or active in the daily operations of the firm.

General partners are mandated to include any guaranteed payments they get and their share of ordinary business income (loss) in their self-employment earnings (loss).

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What is globalization in business.

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Answer:

the increase in the flow of goods, services, capital, people, and ideas across international boundaries.

When cash from operating activities is presented using the indirect method, net income must be adjusted for increases and decreases in balance sheet accounts that relate to

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The name which is given to the process where cash from operating activities is presented using the indirect method and the net income must be balanced is:

Indirect Cash Flow Method

According to  the given question, we are asked to state the  name which is given to the process where cash from operating activities is presented using the indirect method and the net income must be balanced.

As a result of this, we can see that this is called Indirect Cash Flow Method because here, the cash flow can be deduced by checking and making some calculations on the net income from the transactions which were not done in cash.

Therefore, the correct answer is Indirect Cash Flow Method

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would burger king hamburgers or lady gaga mp3s have a deadweight loss smaller relative to the total surplus in its market?

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Competition do exist between firms. For Burger King hamburgers, I will expect deadweight loss to be smaller relative to the total surplus in its market.  This is because the less differentiated products are known to be more difficult to sustain its inefficient prices and the much smaller deadweight loss it has.

Burgers are known to be  less differentiated product and it  need to advertise so as to convince consumers that they should have one burger over another.

Consumers are said to be more indifferent about fast-food. The entry of new firms affects profits by forcing business rivals to compete.

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the best way for federal reserve board officials to help boost a stagnant economy is to

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The most beneficial way for the Federal reserve board officials to help boost such economy is to lower interest rates so that the banks can provide more loans at cheaper rates to individuals and businesses.

The federal reserve board officials are nominated by the President and Senate to oversee the activities of the federal reserve.

Typically, the stagnant economy is characteristic by increasing interest rate which will discourage borrowing from bank.

However, if the officials lower the interest rate for bank, it will encourage more provision of loans to borrowers.

Therefore, the most beneficial way is to lower interest rates so that the banks can provide more loans at cheaper rates to individuals and businesses.

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Taxes assessed on which single industry form a significant source of income for the state and add an element of unpredictability when projecting future revenues

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Considering the macroeconomic analysis, Taxes assessed on the Petroleum or Oil industry form a significant source of income for the state and add an element of unpredictability when projecting future revenues.

This is because the petroleum industry is known for its high generating revenue, which has become a significant export for many countries worldwide.

Some countries that rely on petroleum or oil industry include OPEC countries, Russia, Brunei, etc.

However, given that many technologies are trying to move away from Petroleum energy, and due to its non-renewable nature, the revenue from the Petroleum industry is considered unpredictable.

Hence, in this case, it is concluded that the correct answer is Petroleum Industry.

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Do you think the united states should adopt information-control regulations similar to britain's official secrets act? explain why or why not.

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Answer:

no they should ent

Differentiate between equity financing and debt financing?

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Answer:

When a business wants to obtain cash, it has two options for financing: equity financing and debt financing. Equity financing is the most common kind of financing accessible to companies. Debt financing refers to the borrowing of money, while equity financing refers to the sale of a piece of the company's stock.

Explanation:

Hope it helps:)

In which situation may completion of an approved refresher course or 120 hours of continuing education most likely be required

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A practicing nurse who allowed her license to lapse about 7 years ago because of family raising may be required to complete an approved refresher course or 120 hours of continuing education.

A nurse can opt to let their medical license lapse if they want to raise a family since they need to give a full attention.

However, the nurse can obtain new license by completing an approved refresher course or 120 hours of continuing education.

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a competitive firm’s short-run supply curve is its ________ cost curve above its ________ cost curve.

Answers

Answer:

marginal and average total

Explanation:

A competitive firm's short run supply curve is the portion of its marginal cost curve that lies above its average total cost curve.

A company's debt-to-assets ratio is 0.7 or 70%. If the company issues common stock for cash, then the debt-to-assets ratio will ______.

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Answer:decrease

Explanation:

A company's debt-to-assets ratio is 0.7 or 70%. If the company issues common stock for cash, then the debt-to-assets ratio will be decreased.

What do you mean by debt-to-assets ratio?

The primary purpose of the debt-to-total assets ratio is to assess a company's capacity for borrowing additional funds. By comparing the ratio to other businesses in the same industry, that assessment is made.

Debt capacity measures a company's power to service its existing debt as well as its capacity to borrow money if necessary from additional sources of debt.

A corporation is said to be more leveraged the higher its debt-to-total assets ratio. If their revenues fall, highly leveraged businesses have a higher risk of missing loan payments, and it is more difficult to obtain additional debt to weather a slump.

Therefore, a company's debt-to-assets ratio is 0.7 or 70%. If the company issues common stock for cash, then the debt-to-assets ratio will be decreased.

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what importance does the stationery and information sources play in the effective and efficient Operation of an organization?​

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Based on the organizational activities model, the importance of stationery and information sources in the effective and efficient operation of an organization includes "the source of quality and quantity data on the production input."

Some other importance of stationery and information sources in the effective and efficient operation of an organization includes the following:

It serves as the place to gather data about the strengths and weaknesses of the firms.It is also the source to gather the information opportunities and threats of the organizations.It is also a source of keeping records of finance, employees, success, and failures of the firms.

Hence, in this case, it is concluded that the stationery and information sources in an organization are vital to its success.

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Most financial securities have some level of ________ risk. Multiple Choice unsystematic asset-specific diversifiable industry systematic

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Based on financial analysis, Most financial securities have some level of asset-specific risk.

This is because asset-specific risk is a type of risk that is unique and common to financial securities.

Asset-specific risk is often referred to as Asset-backed risk, which, like any other financial risk, concerns the tendency of losing money.

Other types of risks associated with financial securities include the following:

Credit risk, Liquidity risk, Foreign investment risk, Equity riskCurrency risk

Hence, in this case, it is concluded that the correct answer is "Asset-specific risk."

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Can someone please reading this and tell me if it sounds good so far, thanks!

Answers

It sounds good so far! nice job

It actually isn't bad; I would take out the freshman year sentence though.

9. Describe some research strategies implemented by economists to prove the existence of labor market discrimination based on race.

Answers

Answer:

Explanation:

I

n this article, we discuss the theory and evidence on discrimination in two

key domains—the labor market and the criminal justice system—from an

economic perspective. We define discrimination as treating someone differently based on characteristics such as gender, race, or religion. Prejudice may lead

to discrimination, but only if you act on it. Moreover, discrimination by individuals

does not necessarily lead to discrimination at a market or societal level. We focus

primarily on discrimination against blacks, although many of the concepts l assessment of a nonrepresentative

sample, as when an employer ascribes differences in an earlier job applicants pool

to a current one even though the applicant population has changed.

The canonical Becker ([1957] 1971) model of employer discrimination suggests

that market forces push back against taste-based discrimination, because prejudiced

employers will pay more for (or hire less qualified) preferred race workers, thereby

decreasing profits. Consequently, in a basic model, competition from nondiscriminating firms drives discriminators from the market until wage

what is the child abuse prevention hotline number

Answers

Depends on what state you live in.

Paul Mason's firm sells medical equipment to heart surgeons. The company fields a direct sales force that travels the country demonstrating its equipment to heart surgeons and hospital administrators. Recently, Paul's company started producing equipment for eye surgeons, partly to maximize the value of his sales force, which can now call on both heart surgeons and eye surgeons when it makes hospital visits. Paul's firm is attempting to capture economies of ________ through this strategy.

Answers

Answer:

scope

Explanation:

why do we need to suffer from taxes

Answers

Answer:

because it is very important so we can know the answere

Can someone please read this and tell me if it sounds good so far, thanks!

Answers

Answer:

I think It sounds great! just make sure to check for punctuation and any run-on sentences :)

Explanation:

Explain why most trade occurs because of comparative advantage. Be sure to provide examples from the data tables or from the lesson to support your answer.

Answers

Most trade is due to the comparative advantage of an organization's ability to produce a good or service with lower marginal cost and opportunity cost.

As an example, we can cite trade between Africa and the United States, where Africa markets agricultural products such as corn and citrus to the US, and the US markets technological products such as computers to Africa.

Therefore, companies will use comparative advantage to acquire goods and services at lower prices than other competitors.

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The blue curve on the following graph represents the demand curve facing a firm that can set its own prices.

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From the graph analyzed in the question, the price will be $100 per unit while the quantity demanded will be 10 units.

From the complete question, the marginal revenue of the fourth unit that is produced will be:

= (160 × $4) - (170 × $3)

= $640 - $510

= $130

The marginal revenue of the eighth unit will be:

= (120 × 8) - (130 × 7)

= 960 - 910.

= $50

Therefore, the marginal revenue of the eighth unit is $50.

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Suppose the customer data analysis software used by ABC Bank is significantly changed, and its documentation is therefore revised, but no new features are added. This type of maintenance is called a _____.

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Based on the information given this type of maintenance is called a maintenance release.

A maintenance release is a release which help to make correction on security issues such as threat  or vulnerability without modifying or adding new features to the software.

Maintenance release help to fix or repair programming errors that  occur during the software life cycle stage or programming error that occur due to mistake during the requirement stage validating process.

Software that are released often undergo a maintenance release so as  detect and fix any error or bug that was detected.

Inconclusion this type of maintenance is called a maintenance release.

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Oreo cookies are now extremely expensive to purchase. Instead of buying oreo cookies, i now want to buy chips ahoy. What determinant of demand does this likely fall under?.

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In economics, the determinant of demand that this scenario fall under , when you go for chips ahoy because Oreo cookies are now extremely expensive is Change in Price of Substitute Good.

What is Substitute Good?

A substitute good  can be regarded as product or service that  is been used as alternative for other goods.

It should be When the price of a substitute good rise, then demand for the other substitute as well will rise.

This is referred to as  positive cross price elasticity.

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A collective good offers particularized benefits while private goods are broadly distributed. True False

Answers

The answer would be true

Craig Conway is CEO of a software design company named PeopleSoft, a company that has automated many human resource functions such as tracking vacation time. Conway operates at the __________ level of his organization.

Answers

The level at which Conway operates at his organization is called the Corporate Level.

Corporate Level strategy means the top hierarchy approach for administering and directing the entire activities of the organization

Here, Craig Conway is the CEO which is a top-hierarchy for his company. Any operation planned, administered and directed from his position in the organization means he is operating at the Corporate Level

Therefore, the level at which Conway operates at his organization is called the Corporate Level.

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During the ________ stage of system development, systems tests are evaluated by users and reviewed by management.

Answers

Answer:

acceptance testing

Explanation:

Which sales tactic offers potential customers the opportunity to try a product or service before they make a buying decision

Answers

Trial period of a product or service such as 7 days free with the option to cancel within the 7 days or continue the service

the starting point for preparing the operating activities section using the indirect method is ______.

Answers

Organizations often have different operations. The starting point for preparing the operating activities section using the indirect method is Net income.

Net income is simply known to be the gross profit and removing  all other expenses, costs and any other income and revenue sources that are not included in gross income.

A lot of other costs is often removed from gross to make it be at net income. They  include interest on debt, taxes, and operating expenses or overhead costs.

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How is federal income tax calculated on a paycheck.

Answers

Answer:

Multiplying taxable gross wages by the number of pay periods per year to compute your annual wage.

Explanation:

Country Kelani has I = $200 billion, S = $400 billion, and purchased $600 billion of foreign assets, how many of its assets did foreigners purchase?

Answers

Answer:

$400 billion

Explanation:

options:

A) $0 billion

B)$1,200 billion

C) $200 billion

D) $400 billion

D) $400 billion is correct answer

(Hope this helps can I pls have brainlist (crown)☺️)

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