The ICH GCP guidelines:
- set standards for the design, conduct, monitoring and reporting of clinical research.
- guarantee that a submission in any ICH region will be approved for marketing.
- require certification of clinical research sites and investigators
- replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S.

Answers

Answer 1

Answer:

Explanation:The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.        

the last


Related Questions

what is an imaginary line that extend horizontally from east to west in a globe?​

Answers

Answer:

The imaginary east-west horizontal lines, which run parallel to the equator, are called Latitudes or Parallels.

Answer:

The imaginary horizontal lines running in east-west direction on the Earth's surface are known as Latitudes or parallels of Latitude as they are Parallel to each other.

Explanation:

A standing Order of $25 for insurance appears in the debit column of the Bank Statement. This amount does not appear in the Cash Book. How is this item treated in order to update the Cash Book.

a. Substract the $25 from the Bank Statement balance
b. Add $25 to the Bank Statement balance
c. Credit the Bank Account with $25
d. Debit the Bank Account with $25

Answers

Answer: c. Credit the Bank Account with $25

Explanation:

Insurance is an expense which means that the Standing Order reduced the amount of cash that the company had in the bank and this was reflected by the bank statement.

In order to reconcile the bank statement balance to the bank account balance, the bank account balance needs to be reduced as well. As it is an asset, it will be reduced by crediting it for the $25 standing order.

Maurice is a cautious investor. He wants to make sure that any financial advice that he pays for is as free of conflicts of interest as possible. Given this objective, Maurice should seek out a financial advisor who provides advice and products based on a ______________________ standard. Group of answer choices contingency. contractual. fiduciary. suitability.

Answers

Answer: fiduciary

Explanation:

Since Maurice is a cautious investor and wants to make sure that any financial advice that he pays for is as free of conflicts of interest as possible, he should then seek out a financial advisor who provides advice and products based on a fiduciary standard.

The fiduciary standard simply states that the interest of the client should be out above the interest of the advisor and the advisor must follow the best course of action for the client regardless of how they're affected by this.

Which of the following is NOT a reason to make payments online? ​

Answers

Answer:

Hi there isn't anything attached??

If you purchase a straddle on euros, this implies that you: A) finance the purchase of a call option by selling a put option in the euros. B) finance the purchase of a call option by selling a call option in the euros. C) finance the purchase of a put option by selling a put option in the euros. D) finance the purchase of a put option by selling a call option in the euros. E) None of the above.

Answers

Answer:

The correct answer is E) None of the above.

Explanation:

when you purchase a straddle on euros, this means you simultaneously buy a call option and a put option on the same common stock on euros bearing a similar expiration date, and the same place where the security can be bought and sold. What this means is, you tend to make a profit once the common stock makes a sharp move. Normally, call options give investors the liberty to sell stock expecting a rise in price, while a put option gives the investors want to sell their stock because they predict a fall in price. These two option contracts aim at making investors make profits.

Even before Michelle could explain why a prospect had not purchased her company's new line of ecofriendly outdoor furniture, her supervisor started explaining how she should have emphasized the fact that the furniture is made through a revolutionary recycling process and that the prices are justified by the furniture's quality and eco-friendly nature. In this scenario, the supervisor provided Michelle with __________ feedback by telling her how she could make better sales presentations.

Answers

Answer:

Informal feedback

Explanation:

In simple words, informal feedback relates to the feedback under which the feedback is not planned by either of the parties involved and the conversation regarding the review just happens occasionally unplanned. I

 Generally, In such feedback there is no exchange of information but one party dictates their view to the other. Hence, from the above we can conclude that the given case is an instance of informal feedback.

All of the following are true about the post-closing trial balance, except: a.It is prepared after posting the closing entries to prove the equality of the debit and credit balances in the general ledger accounts. b.Only permanent accounts are listed in the post-closing Trial Balance. c.The owner's capital balance listed on the post-closing Trial Balance was updated to reflect revenues, expenses, and drawing for the accounting period. d.It is prepared before the closing process.

Answers

Answer:

All of the following are true about the post-closing trial balance, except:

d.It is prepared before the closing process.

Explanation:

The post-closing trial balance is rather prepared after the closing process.  This is the reason it is described as a post-closing trial balance.  Only permanent accounts (balance sheet) are listed on the post-closing trial balance.  The post-closing trial balance ensures that the capital account is updated with the retained earnings (net income less drawings), as the case may be.

Why was agricultural sector declared as critical industry and exempt from the hardest lockdown regulations

Answers

Answer:

Kindly check explanation

Explanation:

Food production and consumption is critical and key to survival, no matter an established and generally accepted number of daily square meal of 3 is widely adopted. This gives a clue tgta, no matter a country's problem or issues they face, aspects which concerns food and generally agriculture would be treated preferentially. Following the outbreak and severe spread of the deadly virus, it became imperative that affected nations introduced critical measures to try and curtail its spread, stringent measures include ; restriction of movement, strict emphasis on social distancing, hence, the need to reduce the number of people on a particular site or work area, travel restrictions, among others. This restrictions had s here effect on the agriculture and the food supply chain and its effect was quickly very noticeable as people would eventually die of hunger if nothing was done. This prompted government to introduce exemptions and preference afforded to the agricultural sector ; such as keppibg trade channels open in other to facilitate food distribution, timely observation and monitoring of food crisis among others.

In answer to a radio advertisement, a teenager two months shy of his 18th birthday contracted to buy a late model car from a car dealership. The agreement required a $1500 down payment with the remainder of the $7200 price to be paid in monthly installments to a local finance company. The teenager’s first eight payments were made regularly until his driver's license was suspended. He then informed the company that no further payments would be forthcoming. The finance company sued for the remaining payments. The age of majority in the teenager’s state is 18 years. Would the teenager be liable for the balance of the payments?
A. Yes, because the car dealership was liable on the contract from the outset, notwithstanding the teenager’s minority.
B. Yes, because he kept the car for six months after reaching the age of majority.
C. No, because he was a minor at the time of the contracting, and the contract is voidable by him.
D. No, because he informed the finance company in a timely manner after his driver's license was suspended.

Answers

Answer: B. Yes, because he kept the car for six months after reaching the age of majority.

Explanation:

When the teenager had not reached the age of majority, holding him liable for the contract would have been challenging. The teenager however reached the age of majority he became legally liable for decisions and contracts.

After this age, he had the car for 6 more months which means that he had accepted the contract as an adult. He cannot therefore simply wiggle out of the payment because he signed an enforceable contract.

Mariano Manufacturing can issue a 25-year, 8.1% annual payment bond at par. Its investment bankers also stated that the company can sell an issue of annual payment preferred stock to corporate investors who are in the 40% tax bracket. The corporate investors require an after-tax return on the preferred that exceeds their after-tax return on the bonds by 1.0%, which would represent an after-tax risk premium. What coupon rate must be set on the preferred in order to issue it at par? Group of answer choices6.66% 6.99% 7.34% 7.71% 8.09%

Answers

Answer:

6.66%

Explanation:

First and foremost, if a bond is issued at par it means that the coupon rate and before-tax yield to maturity are the same. hence, in this case, the before-tax yield on the bond is 8.10%, the same as its coupon rate

after-tax yield on bond=before-tax yield*(1-tax rate)

tax rate=40%

the after-tax yield on bond=8.10%*(1-40%)

the after-tax yield on bond=4.86%

after-tax return on the preferred=the after-tax yield on bond+after-tax risk premium

after-tax risk premium=1.0%

after-tax return on the preferred=4.86%+1.0%

after-tax return on the preferred=5.86%

However, the before-tax  coupon rate on the preferred is determined below based on the dividend received deduction principle obtainable in the US

Pre-Tax Coupon Rate = after-tax return on the preferred/(1-(Tax Rate*Taxable Percentage)

The principle that 70% of dividends, that only 30% are taxable, hence, the taxable percentage is 30%

Pre-Tax Coupon Rate =5.86%/(1-(40%*30%)

Pre-Tax Coupon Rate =5.86%/0.88

Pre-Tax Coupon Rate =6.66%

households play a role in the circular flow of goods

Answers

Answer:

purchasing goods at product markets

Explanation:

Which types of postsecondary education are examples of traditional academic education? Check all that apply.

associate degree
apprenticeship
bachelor’s degree
technical school degree

Answer: 1,3

Answers

Associate degree is a 2 year college degree & a Bachelors’s degree. They would be considered a traditional education.

An apprenticeship studies under a master of a trade.

A technical school degree is training in a field specific to what you want to get a job in, like air conditioning repair.

Answer:

associate degree and bachelor’s degree is the answer

Explanation:

just did it trust me :)

Why does ray of light coming through denser medium bend when it
enters into rarer medium?​

Answers

Answer:

this occurs as a result of different refractive index of the two media

Answer:

It actually depends on the angle at which the incident ray hits the boundary face between both mediums

So if the incident ray coming from an angle enters the rarer medium it causes the refracted ray to bend away from the line of the normal

Step-by-step explanation:

I hope it was of help I tried explaining the best I could

Help please :)

In a circular flow diagram, households represent the elements of the
economy that:
A. sell products to consumers.
B. produce goods and services.
C. provide businesses with materials.
D. purchase and consume products,

Answers

Answer:

Produce good & services

Explanation:

In the circular-flow model of an economy, households own all the factors of production. Households earn their income when firms purchase or rent these factors of production to use them to produce goods and services. Firms, in turn, earn revenue when households buy goods and services.

Answer: B

Explanation:

The Role of Households

In a circular flow diagram, households consume the goods offered by the firms. However, households also offer firms factors so that the firms can produce products for the household to later consume.

what do you call a dog on the beach

Answers

it may be called as hot dog

Answer:

a beagle

Explanation:

Nathalie is willing to apply for a car loan. She is 18 years old, still lives at home with her parents and has a part-time job during nights while attending college. In this scenario, a bank's loan officer is most likely to approve the loan in case that Group of answer choices Nathalie maintains a 3.5 GPA. Nathalie signs over her parents car as collateral. Nathalie provides a cosigner on her loan. Nathalie increases her student loan.

Answers

Answer:

Nathalie provides a cosigner on her loan

Explanation:

In the case when an inidvidual co-signs the loan so the individual is become obligated in a legal way to repay the full loan with respect to nathalie when she is not able to pay the amount. Also the loan officer would permitted in that case when the co-signer has the stable kind of job or the source of revenue.

So, nathalie not sign the car of the parent as the collateral as it required the parent consent

So the above should be the answer

There are two methods to determine the Golden Rule capital level, looking at steady-state: Please choose the correct answer from the following choices, and then select the submit answer button. Answer choices consumption per worker or comparing the marginal product of capital to the saving rate. consumption or comparing the marginal product of capital to the depreciation rate. output per worker or comparing the marginal product of capital to the saving rate. output per worker or comparing the marginal product of capital to the depreciation rate.

Answers

Answer:

consumption or comparing the marginal product of capital to the depreciation rate.

Explanation:

The two methods that measures the capital level of the golden rule is the consumption or it should compared the capital marginal product with the depreciation rate. As the golden rule capital level shows the leval in which the consumption made in the steady rate should be maximized

So for this the above option should be considered

Therefore the other options are wrong

T F Credit reports are issued monthly, so you know how much money topay toward your credit card bill.

Answers

Answer:

False

Explanation:

A financial statement can be defined as a document used for the formal communication or disclosure of financial information and statements to present and potential users such as investors and creditors. These includes balance sheet, statement of retained earnings and income statement.

Generally, financial statements are issued to recipients on a monthly basis.

A credit report can be defined as a financial document that comprises of detailed information about a person's credit history or activities with respect to borrowed money (loans). It is usually prepared by a credit bureau.

A credit score can be defined as a numerical expression between 300 - 850 that represents an individual's financial history and credit worthiness. Therefore, a credit score determines the ability of a borrower to obtain a loan from a lender.

This ultimately implies that, the higher your credit score, the higher and better it is to obtain a loan from a potential lender.

In conclusion, credit reports are issued to a customer on request and at any given time, so he or she knows how much money to pay toward your credit card bill.

Ajax Lighting manufactures and sells street and parking lot lights, such as those on the Fayetteville trail system. Ajax has the best LED lighting technology in the industry. It is a significant competitive advantage. There are only two other companies in the nation that make competitive products. Growth in this industry is about 2% a year or less. Ajax can enjoy sustained competitive advantage because they are in a _________ market

Answers

Answer: slow cycle

Explanation:

Based on the information given, Ajax can enjoy sustained competitive advantage because they are in a slow cycle market.

Slow-cycle markets refers to the markets whereby the competitive advantages of a firm are protected from imitation, which is usually for long periods of time and in this scenario, imitation is usually costly. Therefore, in this market, competitive advantages are usually sustainable

Monetarists believe that changes in the supply of money Question 24 options: do not affect aggregate demand. affect aggregate demand through the loanable funds market only. affect only the investment component of aggregate demand. affect aggregate demand directly.

Answers

Answer: affect aggregate demand directly.

Explanation:

Monetarists believe that money supply is very important in determining the economic growth of an economy and this is why they advocate for monetary authorities to get involved in the monetary system in order to guide the growth of the economy.

To monetarists, the supply of money influences consumption as well as investment and so directly affects aggregate demand because both consumption and investment are components of aggregate demand. For instance, an increase in money supply increases both consumption and investment and so increases aggregate demand.

commercial banks hold deposits and

Answers

Anddd??? What?? You just typed and stopped midway lol
? Umm I don’t get it

Think of a situation when you received a bad news with direct pattern (without any buffer). How did you react in that situation?

Answers

Bajáis s and sjsisiejen ejejd

Answer:

first of all, don't freak out.

stay calm, n think of wat u hv jxt heard. if u can find a solution, do it asap buh if not accept it in good faith

The following details are provided by a manufacturing company: Product line Investment $1,100,000 Useful life 12 years Estimated annual net cash inflows for first year $400,000 Estimated annual net cash inflows for second year $390,000 Estimated annual net cash inflows for next ten years $380,000 Residual value $70,000 Depreciation method Straight-line Required rate of return 14% Calculate the payback period for the investment. (Round your answer to two decimal places.)

Answers

Answer:

2.82 years

Explanation:

The payback is the length of time taken for the investment's cash inflows to equal the initial investment outlay.

In the first two years of the investment, $790,000($400,000+$390,000) would have been recouped out of the initial investment of $1,100,000.

The amount that is expected to be recovered in  year 3  is $310,000 ($1,100,000-$790,000), based on that , we can compute our payback period thus:

payback  period=2 years+(cash flow recovery in year 3/year cash 3 inflows)

payback  period=2+($310,000/$380,000)

payback period=2.82 years

Sanchez Foods Inc. is a large food manufacturing corporation that earns more profits than its competitors. The company uses only organically grown grains and fruits. It also promotes organic farming and helps nonprofit agencies that focus on food and nutrition causes. The company recently decided to use a third-party recycling logo. In this scenario, Sanchez Foods is most likely to have adopted the practice of _______.

Answers

Answer:

green marketing

Explanation:

From the question we are informed about the Sanchez Foods Inc. which is a large food manufacturing corporation that earns more profits than its competitors. The company uses only organically grown grains and fruits. It also promotes organic farming and helps nonprofit agencies that focus on food and nutrition causes. The company recently decided to use a third-party recycling logo. In this scenario, Sanchez Foods is most likely to have adopted the practice of green marketing.

Green marketing can be regarded as practice of developing as well as advertising products which is been

based on their real as well as their perceived environmental sustainability.

In a case, whereby green marketing activities of a Company are not substantiated from significant investments and doesn't substantiated by operational changes, the company

may be criticized as been using false or misleading advertising.

A value chain is a set of: Group of answer choices robotically controlled conveyor belts that deliver product quickly from manufacturing stations to shipping containers. large firms that are vertically integrated. a large number of small firms that dominate a given market. similarly profitable firms competing against each other in any given industry. activities through which a product or service is created and delivered to customers.

Answers

Answer:

activities through which a product or service is created and delivered to customers.

Explanation:

In simple words, A value chain can be understood as the business model that outlines the whole process of creating a product or service. The processes involved in taking a commodity from conception to dissemination, as well as everything in among as sourcing raw materials, production operations and marketing activities—make up a value chain for firms that create things.

Read this excerpt describing the mission of the World Bank. The World Bank is a vital source of financial and technical assistance to developing countries around the world. It is not a bank in the common sense. Instead, it plays a different but supportive role in its mission of global poverty reduction and the improvement of living standards. It provides low-interest loans, interest-free credit, and grants to developing countries for education, health, infrastructure, communications, and many other purposes. According to this excerpt, what is one major way in which the World Bank differs from a regular bank

Answers

Answer: The World Bank aims to improve living standards

Explanation:

According to this excerpt, one major way that the World Bank differs from a regular bank is that The World Bank aims to improve living standards.

Unlike the other banks such as commercial banks that give out loans or help customers keep valuables, the World Bank is a source of financial and technical assistance to developing countries around the world. They seek to improve the living standards of the people and bring about economic growth.

Answer:

B. The world aims to improve living standards

Explanation:

An increase in the price of a good leads to: a decrease in the marginal utility per dollar of that good, and thus a decrease in the quantity purchased. an increase in the marginal utility per dollar of that good, and thus an increase in the quantity purchased. a decrease in the marginal utility per dollar of that good, and an increase in the quantity purchased. an increase in the marginal utility per dollar of that good, and a decrease in the quantity purchased.

Answers

Answer:

a decrease in the marginal utility per dollar of that good, and thus a decrease in the quantity purchased.

Explanation:

In Economics, the law of demand states that, the higher the demand for goods and services, the higher the price it would be sold all things being equal (ceteris paribus).

According to the law of demand, there exist a negative relationship between the quantity of goods demanded and the price of a good i.e when the prices of goods and services in the market increases or rises: there would be a significant decline or fall in the demand for this goods and services.

This ultimately implies that, an increase in the price level of a product usually results in a decrease in the quality of real output demanded along the aggregate demand curve.

Price can be defined as the amount of money that is required to be paid by a buyer (customer) to a seller (producer) in order to acquire goods and services. Thus, it refers to the amount of money a customer or consumer buying goods and services are willing to pay for the goods and services being offered.

The marginal utility of goods and services can be defined as the additional satisfaction that a consumer derives from consuming or buying an additional unit of a good or service.

Hence, if a seller increases the price of a good, it would eventually lead to a decrease in its marginal utility per dollar, and thus, leading to a decrease in the quantity of the good that would be purchased by consumers.

For example, if there's an increase in the price of a chocolate cake, the marginal utility per dollar of the chocolate cake decreases and thus, leading to a decrease in the quantity of chocolate cake that would be purchased by the consumers; leading to a downward slope of its demand curve.

In team dynamics, process losses are best described as: Question 1 options: resources expended towards team development and maintenance. information lost due to imperfect communication among team members. knowledge lost when tacit knowledge is converted to structural knowledge. productivity losses that occur when individual members need to learn a new task. knowledge lost when a team member leaves the organization.

Answers

Answer:

resources expended towards team development and maintenance.

Explanation:

A team can be defined as a group of people or set of individuals with various skill set, knowledge and experience coming together to work on a project or task in order to successfully achieve a set goal and objective.

This ultimately implies that, a team comprises of individuals, workers or employees having complementary skills, knowledge and experience needed to execute a project or task successfully.

In team dynamics, process losses are best described as resources expended towards the development and maintenance of a team for increased production and benefits.

all three level of professionals are required to run an organization or a business is smoothly classified as a statement ​

Answers

All three levels of professionals are required to run an organization or a business smoothly. Justify this statement.

Answer:

It is TRUE that All three levels of professionals are required to run an organization or a business smoothly.

The three levels of professional required are:

Top-level management

Middle-level management

Low-level management

Explanation:

Top-Level Management

Top-level managers or professionals are the people that involve in taking an extensive means of actions or decisions for the firm or business as a whole and focus on the long-term success of the business or company. They take up roles such as Chief Operations Officer (COO), ), Chief Financial Officer (CFO), Chief Executive Officer (CEO), etc.

Middle-Level Management

Middle managers or professionals are an essential part of an organization and they are involved in the intermediate management operation whose responsibility involved supervising the lower-level managers to meet the company's goals. For example, they are General managers, branch managers, department managers, etc.

Low-Level Management

Low-level managers or professionals are a core part of organizations, they ensure there is a practical technique and creativity with strong interpersonal skills to maximize particular operational processes to achieve organizational success. For example, they are Office Manager, Shift Supervisor, Store Manager, etc.

Some studies done by economists have found that the original inventor receives __________ from innovations, while other businesses and new product users receive the rest of the benefit. Group of answer choices one-quarter to one-half of the social and economic benefits one-quarter to one-third of social and economic benefits one-third to one-half of the total economic benefits one-quarter to one-third of the total economic benefits

Answers

Answer:

one-third to one-half of the total economic benefits.

Explanation:

Innovation typically involves the creation of a new product of any category such as automobile, building, phones, electronics, etc., that generates money for the innovators or manufacturers through purchase made by the end users (consumers).

A patent can be defined as the exclusive or sole right granted to an inventor by a sovereign authority such as a government, which enables him or her to manufacture, use, or sell an invention for a specific period of time.

Generally, patents are used on innovation for products that are manufactured through the application of various technologies.

Some studies done by renowned economists around the world have found that the original inventor receives one-third (⅓) to one-half (½) of the total economic benefits from his or her innovations, while other businesses and new product users receive the rest of the benefit.

Other Questions
please may I get help please whish way should I use Which set of numbers is included as part of the solution set of the compound inequalityx < 6 orx > 10? ANSWER PLZ WILL MARK BRAINLIEST!!!!!! help me to do this please What is the radius of a sphere with a volume of 28526 in 3 , 28526 in 3 , to the nearest tenth of an inch? Please Help. What is the name of the process that plants use to remove carbon dioxide from the atmosphere?1.) transpiration2.) photosynthesis3.) respiration4.) decomposition A shopping attendant needs to price a large jigsaw puzzle returned by a customer. The customer paid a total of $33.04, including a convenience charge of $1.75 and 10% sales tax on the subtotal. Use the inverse to find the original price of the puzzle. If necessary, round your answer to the nearest cent. What impact did the hard-lockdown have on the perfect markets? chromosomes_____ select all that apply -always occur in pairs-are tight coils of dna-can be analyzed in a karyotype-carry thousands of genes-are carried on genes SEE ATTACHED IMAGE, THANK YOU! Please help find the diagonal distance thank you Hey, could you help me? Thank you what is the narrator relationship with dee I will be so thankful if u answer correctly!! Please help this is for a test no scams or links please 10.Bishop Barron is very concerned about Religion fading and growing weaker in our society, "When Religion is silenced then the deepest longing of the heart is not awakened, it's not named, it's not called forth which is why the Dictate Sensitivity Editor Reuse Files Rruse Files C whole society suffers enormously from the loss of God." Do you agree or disagree with this quote? Why or why not? to prepare chili con carne or refried beans, which kind of bean would yo select? 28. Fill in the blank in the following sentence with the superlative phrase that willmake the sentence mean "China is the largest country."C'est la Chine What is the current to the following DNA strand TATTAGATTACA A rectangular farm has an area of 1/2 square miles. If its length is 1/3 miles, what is its width?Will give brain lest Yevgenia walks 8 x 2/3 miles every week which fraction represents the number of miles that Yevgenia walks each