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

Natalie books an appointment at a hair salon to get a haircut, color, and a blow dry. When it is time for her appointment, she shows up at the salon and receives these services from a stylist. This scenario illustrates that services

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The scenario where Natalie books an appointment and shows up at the salon to receives the services illustrates that services are usually distributed through direct marketing channels.

Direct marketing channel refers to the sales process which directly involves the seller and end buyer without the service of intermediary.

In a direct marketing channel, the service of intermediaries (such as retailers, agent, wholesalers) are not prioritize

The medium which are most perfect for direct marketing channel includes through internet, digital media etc

In the question, Natalie books an appointment with the stylist through her phone without the service of intermediaries.

Therefore, the scenario best illustrates that services are usually distributed through direct marketing channels.

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a country opens to trade. if the world price of a good exceeds the domestic price, the result will be:

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Based on macroeconomic theory, a country opens to trade. If the world price exceeds the domestic price, the result will be export.

This is because it is beneficial or advantageous for a country to export its goods when the world price exceeds the domestic price.

This implies that the country's export goods will be cheaper than the world price of such goods.

In turn, other countries would demand their goods because of lower prices, thereby promoting more exportation of such goods.

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

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As a project lead, your team is on its way to finishing work on the project, while you have the impression that a staff member is already negotiating the next assignment in another project. You are afraid that the person may come under pressure to start working on the other job before she has finished her work for your project. Her task is very complex, and it would be hard for someone else to take up the partial results and finish them. What action is most likely to resolve the situation

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The action most likely to resolve the situation is to use your network of project managers to find another role for the person that allows for a smooth transition and doesn't conflict with your needs.

This is the best course of action because a smooth transition between projects allows for greater motivation in the current project, according to the PMBOK.

Therefore, using your network of project managers to find another assignment and allow for a smoother transition that doesn't conflict with your needs is the most suitable option.

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List the four steps in preparing a statement of cash flows in the correct order. Instructions Choice 1 of 4. determine the net cash flows from financing activities toggle button determine the net cash flows from financing activities Choice 2 of 4. determine the net cash flows from investing activities toggle button determine the net cash flows from investing activities Choice 3 of 4. calculate the net cash flows from operating activities toggle button calculate the net cash flows from operating activities Choice 4 of 4. combine operating, investing, and financing activities toggle button combine operating, investing, and financing activities

Answers

The four steps in preparing the statement of cash flows in the correct order includes:

Calculation of net cash flows from operating activities.Calculation of net cash flows from investing activitiesCalculation of net cash flows from financing activitiesCombination of operating, investing and financing activities.

The cash flow statement is a financial statement that helps to summarizes the company's value cash and cash equivalents which enters and leaves the business.

The steps in preparing the statement of cash flows in order includes:

Calculation of net cash flows from operating activities.Calculation of net cash flows from investing activitiesCalculation of net cash flows from financing activitiesCombination of operating, investing and financing activities.

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I'LL GIVE BRAINLIEST!!!
The Smith family wants to relocate to a neighborhood with better schools before their three-year-old goes to kindergarten. They talked with Byron about properties he has for sale in neighborhoods they would like to live in. They also mentioned to Byron that they both work and may need someone to help with in-home care for their child. Byron gave them Taylor’s name to call about childcare. The Smiths also said they were having a hard time getting loan approval, so Byron suggested that they call Travis. Which best describes the jobs performed by Byron, Taylor, and Travis?

Byron is a Customer Service Representative, Taylor is a Child Care Worker, and Travis is a Loan Counselor.
Byron is a Real Estate Manager, Taylor is a Nanny, and Travis is a Loan Counselor.
Byron is a Real Estate Manager, Taylor is a Preschool Teacher, and Travis is a Customer Service Representative.
Byron is a Home Counselor, Taylor is a Nanny, and Travis is a Property Manager.

Answers

Answer:

option C Byron is a Real Estate Manager, Taylor is a Preschool Teacher, and Travis is a Customer Service Representative.

Explanation you can give other guy brainliest

According to the passage, Byron is the real estate manager, Taylor is the preschool teacher and Travis is a customer service representative.

What is real estate manager?

Real estate manager is a person who deals with property. He sells the property act as mediator between the seller and the buyer. He also determines the rental income and act as negotiator in the lease agreement.

In the passage the Byron occupation is of real estate manager who helps in the Smith family for selling their property. The child of smith requires the childcare. Thus Taylor is the preschool teacher.

Travis is the customer service representative who is requires by the smith family to approve the loans.

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Shelby hired Lynn, an attorney, to represent her in an employment discrimination case. Lynn is a(n) _____ who has a duty to act on behalf of Shelby. Shelby hired Lynn, an attorney, to represent her in an employment discrimination case. Lynn is a(n) _____ who has a duty to act on behalf of Shelby. principal fiduciary trustee employee third-party beneficiary

Answers

The answer is fiduciary

the vice president of finance at adventure park, an amusement park, disseminated a new five-year strategic plan to the merchandise, attractions, and operations directors. this is an example of ________ communication.

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When the vice president disseminated the 5 year strategic plan to the directors. it is definitely an example of downward communication.

A downward communication refers to the flow of communication or information from top hierarchies to the lower ranks.

When a CEO pass an important message through mail to all lower hierarchies of his organization, this type of communication flow is known as downward communication.

In this question, the vice president is disseminating information to different directors below him, so, it is an example of downward communication because the information flows from high to low hierarchy.

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Which of the following is NOT a possible tax or deduction that could be withdrawn from your paycheck?

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Government often deduct tax from income of the people. The option that is not a possible tax or deduction that could be withdrawn from your paycheck is Sales tax.

A sales tax is simply known as a tax paid to body (Government/set up body)for the sales of specific goods and services.

The law gives seller the right to collect funds for the tax from the consumer at the point of purchase.

It is a tax that  is placed on goods or services that is paid to a governing body directly by a consumer.

See full question below

Which of the following is NOT a possible tax or deduction that could show up on your paycheck?

Answer choices

State income tax Contributions to retirement savings FICA Sales tax

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Answer:

sale tax

Explanation:

When a company issues no-par common stock, the ______. Multiple select question. cash inflow is classified as a financing activity

Answers

When the company issues no-par common stock, then, the:

entire amount of the proceeds will placed in Common Stock account. the cash inflow will be classified as a financing activity.

The no-par common stock is a stock issued without a par value.

The value of the no-par common stocks is determined by price that the investors want to pay on the open market.

In conclusion, the entire amount of the proceeds will placed in Common Stock account and the cash inflow will be classified as a financing activity.

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Should a business email contain a salutation?

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Answer:

A business email is meant in a professional way. It can be sought out as multiple different approaches, one of them, in this case, can include a friendly and welcoming business approach, including a salutation. All in all, it is up to the writer, there is no fully correct answer. Hope this helps :)

a fringe benefit plan where employees choose the package of benefits they want up to a certain dollar amount is called a __________ plan.

Answers

There are different types of benefit plan. A fringe benefit plan where employees choose the package of benefits they want up to a certain dollar amount is called a cafeteria-style plan.

Fringe Benefits  is simply regarded as Benefits such as sick-leave pay, vacation pay, pension plans etc., that stands for an additional compensation given too an employees that is far above base wages.

A cafeteria-style plan is a plan that gives employees coverage of expenses in cases like prescription medicine through the withholding of a part of their pre-tax salary.

Employers do gain through the use of these plans as they will not pay FICA on cafeteria-style benefits plans.

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Use the word SMART goal in a sentence:​

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Answer:

He was the smartest kid in the class because he knew how to solve the hardest math problem on the worksheet.

Explanation:

A trial balance is a listing of which balances?

Answers

Answer:

A trial balance is a list of all the general ledger accounts (both revenue and capital) contained in the ledger of a business

Explanation:

Hope this helps :)

Mark me as brainliest if it did.

1. A company wants to build a new voting kiosk for sales to governments around the world. Which IoT technologies should the company choose to ensure the highest degree of security

Answers

Based on the situation described in the question, the IoT technology that the company should choose to ensure the highest degree of security is "Azure Sphere."

This is because Azure Sphere is the operating system that Microsoft designs to ensure the dealers of Internet of Things devices increase their security by incorporating a specific system on a chip.

Azure Sphere is known for its protection, high-level application functionalities, and well built-in communication and security traits for internet-connected devices.

Hence, in this case, it is concluded that the correct answer is "Azure Sphere."

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1. Which product type (coffee/ espresso/ herbal tea/ tea) yields the maximum profit in each market size(major/small)? (2 points).

Answers

Coffee is the maximum profit

complete the table by indicating the change in each determinant necessary to increase aggregate demand.

Answers

Aggregate demand often experience an increase and decrease due to different factors. The table showing the change in each determinant that is necessary to decrease aggregate demand.

Consumer expectations about future profitability = improveGovernment spending = IncreaseInterest rates = IncreaseThe value of the domestic currency relative to the foreign currency = Appreciate/Increase.

Aggregate demand is simply known to be the sum of the consumption expenditure, government expenditure, investment expenditure, and net exports of a country.

It is often used to know the changes in income, output, and level of employment in the economy.

A decrease in aggregate demand will make Consumer expectation about future profitability Worsen while an increase in aggregate demand will make Consumer expectation about future profitability to improve.

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match each label to the appropriate scenario. note that some labels may be used more than once, while other labels may not be used at all. additionally, some scenarios may apply to multiple labels, while other scenarios will only apply to one label.

Answers

Demand and supply increases in this scenario:

Gasoline: a new housing development goes up. Several new gas stations are built nearby

Demand increases and supply decreases in this scenario:

Taxis: public transit workers at a popular tourist attraction go on strike as a holiday weekend approaches

Demand and supply decreases in this scenario:

Pumpkins: an early frost destroyed much of the pumpkin crop. A newspaper reports zucchini is better for pie than pumpkin.

Demand decreases and supply increases in this scenario:

Corn: news media run stories about people with corn allergies. The corn crop is unusually large.

The factors that lead to a change in the demand of a good

Change in the price of a substitute good: if the price of a substitute good increases, the demand for the good increases and if the price of the substitute decreases, the demand for the good decreases.

Reports: If a favourable report is released about a good, the demand for the good would increase. If the opposite is the case, the demand for the good would decrease.

Change in weather: When winter is approaching, the demand for winter coats would increase and it would decline in summer.

Factors that lead to a change in supply

A change in the number of suppliers: if the number of suppliers of a good increases, there would be an increase in supply of the good. If the number of suppliers declines, there would be a fall in supply.

Natural disaster: A flood would reduce the supply of a good.

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How to calculate percent yield.

Answers

Answer:

experimental yield divided by theoretical yield multiplied by 100

Explanation:

Which elements exist in the completed assignment?
Check all that apply.
O a Birthdate field
all grade 12 students with a check mark in the
Active field
a Grade field between the Student Number and Last
Name fields
O an E-mail field
a Clip Art image attached to a customer field

Answers

Answer:

a Birthdate field

a Grade field between the Student Number and Last Name fields

Explanation:

edg 2022

an example of a non-pecuniary job characteristic is

Answers

Answer:

A comfortable work environment.

Explanation:

how much money was spent on black friday this year?

Answers

Answer:

a lot of money was spent this year

what is called higher level education​

Answers

Tertiary education leading to award of an ecademic dagree.

Company A wants to buy company B, but company B is unwilling to sell. However, company A is able to complete a hostile takeover and purchase control of company B against its will. What is the most likely explanation for why this is possible? O
A. Company B is a cooperative, meaning that it must cooperate with any offer to purchase it for a fair market price.
B. Company B is a franchise, and company A has convinced the parent company to revoke its licenses. C. Company B is a publicly traded company, so company A can buy the majority of its ownership shares.
D. Company B is an LLC, meaning that the board of directors is not liable to protect the company's interests.​

Answers

Answer:

Explanation: b

Which type of advertising focuses on promoting an organization or business as a whole rather than specific goods or services

Answers

Answer:institutional

Explanation:

The most important labor force issue for developed economies is their _________ populations. global diverse aging all of these

Answers

The answer here is ‘aging’.

I hope this can help.

When a firm decides to combine multiple modes of transportation to complete a single long-distance movement of freight,

Answers

The term that explains when a firm utilize the combination of multiple modes of transportation so they can have a movement of freight is Multimodal Transport.

Multimodal Transport can be regarded as the combination of different means of transport. This is done by a firm so they can facilitate the movement of cargo.

This is done when a long distance movement of freight is required.

Therefore, the correct term is Multimodal Transport

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The banking crisis of 2008 is quite interesting to analyze. The factors that led to this near banking collapse are intriguing to say the least. In this exercise you will be evaluating the factors that led up to the crisis and determining which ones could have created this scenario.

There is no simple answer to what led to the banking crisis, as there were many factors that contributed over a long period of time. Understanding the factors that led to the crisis is very important, as such an understanding will help regulators prevent similar situations in the future.

Please analyze the factors that are given to determine which ones could have potentially worked together to have created the banking crisis of 2008, and then place each factor in the category of either “Major Contributor” or “Little or No Contribution.”

Answers

Banking crisis of 2008 was due to thr global financial crisis that occure during the period

The global financial crisis was a severe worldwide economic crisis.

The financial crisis was rated the most serious financial crisis since after the Great Depression that happened in the 1920s to 1930..

1. Repeal of some provisions of the Glass-Steagall Act of 1933 is a Major contributor to the Banking crisis of 2008.

2. Savvy individual investors is not a Major contributor to the Banking crisis of 2008.

3. The Community Reinvestment Act (CRA)   is a Major contributor to the Banking crisis of 2008.

4. Borrowers’ lack of financial knowledge is a Major contributor to the Banking crisis of 2008.

5. The Troubled Asset Relief Program (TARP) is a not a Major contributor to the Banking crisis of 2008.

6. Mortgage-backed securities (MBSs) is a Major contributor to the Banking crisis of 2008.

7. Electronic Fund Transfer System (EFTS)  is not a Major contributor to the Banking crisis of 2008.

8. Looser governance of loan requirements is a Major contributor to the Banking crisis of 2008.

9. Loans with variable interest rates  is a Major contributor to the Banking crisis of 2008.

10. The creation of the FDIC is a Major contributor to the Banking crisis of 2008.

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Answer:

Explanation:

quick way to get the answer your looking for took a pic of the diagram!

The balance in the accumulated depreciation account represents the:

Answers

The balance in the Accumulated Depreciation account represents the amount to be deducted from the cost of the plant asset to arrive at its fair market value.


Josue is determined to play the saxophone in the school band. How could joining the band benefīt his college or career
O It demonstrates his passion for helping others.
O It gives him military experience
O It provides extra spending money.
O It shows that he is creative.​

Answers

Answer:

I personally would say D: It shows that he is creative.

Explanation:

Mostly because it makes sense, playing a saxophone wouldnt show his passion for helping others, nor give them military experience. Note it also says that how it benefits of his collage or career, so why would he spend money on anything? Most obvious answer would be D.

Sorry if I'm wrong but its a shot in the dark that I'm willing to make, it just looks and sounds right.

The auto insurance plans available from Fret-No-More Auto Insurance are outlined in the table below. To be considered "full" coverage, an insurance plan must include one level of coverage from each category. What is the annual premium for the cheapest insurance plan available from Fret-No-More that is considered full coverage?.

Answers

There are different types of car insurance. The annual premium for the cheapest insurance plan available from Fret-No-More that is considered full coverage is $473.16

Insurance is often made for vehicles. The six most used car insurance coverage options are:

Auto liability coverage Uninsured and underinsured motorist coverageComprehensive coverage, Collision coverageMedical payments coverage and Personal injury protection.

These insurance are often taken based on where a person live, They can be mandatory and optional coverage types.

Auto insurance is a contract between you and the insurance company that protects you against unforeseen accident or theft.

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Answer:

A: $473.16

Explanation:

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A student has a sample of ocean water that they take to science class. what steps could be taken to determine to classify the ocean water as a suspension, solution, element, or compound?A) Examine the pH of the sample. If the pH is exactly neutral, it is a pure substance that is a compound.B) Evaporate the water. If salt is left behind, the sample is a mixture that can be defined as a solution.C) Let the sample settle. If the salt settles to the bottom, it is a mixture that is classified as a solution.D) Observe the diffraction of light as it moved through the sample. If light does not scatter, it is a pure substance that is elemental. Create a short (4+ Complete Sentences), funny story using invented words for as many things as you can. Pretend you are in a world that has animals, birds, trees, useful tools, and people that have never been seen before. You have to invent names for all of them. Find the surface area of the ball shown to the right d=20 What is the total amount of ozone remaining Answer these:Thanks in advance! Suppose a principal amount of $7500 was invested at an interest rate of 6%. How long did it take to reach $10650? if you get it right ill mark brainliest Item 3Is this function linear or nonlinear?y=2x4linearnonlinear make v the subject of the formula how long does it take for chlorine to evaporate from water? A 10-pound bag of grass seed will cover an area of about 4000 square feet. The relationship between pounds (p) of grass seed and area (a) can be written as a = kp. What is the value of k? what does it represent Which words in the passage help create the seriousand intense tone? Check all that apply.violently""thirty""threatened""known""Terror" Which phrase best describes a research plan?O a detailed timeline that presents the steps for conducting researchO a detailed timeline that identifies the drafting and revising steps of writingO a schedule that remains unchanged to ensure that the writer meets the final deadlineO a schedule that prioritizes research collection over the development process In what way did the bourgeoisie differ from other members of the third estate? *. Apakah hyundai pernah memenangkan trofi pabrikan f1?. Amakiri spent N125 for a camera and some film. The camera cost N100 more thanthe film. What percent of the cost of the two items did Amakiri spend for the camera? Jenny bought some books she spent a total of 58 dollars after a discount of 7 dollars off of her total purchase . each book cost 5 dollars . How many books did she buy Solve.4 3/4=x1 1/5What is the solution to the equation?Enter your answer as a simplified mixed number in the box.X= ?? I NEED HELP ASAP PLZIs it that insidious smile with which our petition has been lately received? Trust it not, sir; it will prove a snare to your feet.How does the author's use of the phrase "a snare to your feet" impact the tone of the speech? A. It emphasizes the sense of confidence that the American people shared with the British colonialists. B. It highlights the sense of discontentment between the British government and the American people. C. It highlights the sense of hesitation that the American people felt in fighting the British. D. It emphasizes the sense of deviousness with which the American leaders fought the British. 182 divided by 7 step-by-step