An investigator proposes to study a market approved product sold to treat high blood pressure in individuals over age 12. This study will look at using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in children. Which of the following is the investigator’s most appropriate course of action?
A) Submit the research protocol to OHRP for their review
B) Submit the research protocol to the IRB, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication.
C) Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting research.
D) Submit an Investigational Device Exemption (IDE) application to the FDA.

Answers

Answer 1

Answer: Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research

Explanation:

From the question, we are informed that an investigator proposes to study a market approved product sold to treat high blood pressure in individuals over age 12 and that this study will look at using a liquid formulation for children under age 12.

We are further told that the drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in children.

The investigator’s most appropriate course of action will be to submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting research.


Related Questions

Which of the following is TRUE? Group of answer choices Flexibility in structure is more important than stability. Strategy has a more important influence on structure than structure has on strategy. Large organizations can retain a simple structure as long as they have a focus strategy. Organizations tend to change structure too frequently, which erodes their competitive advantage.

Answers

Answer: Strategy has a more important influence on structure than structure has on strategy

Explanation:

Organizational structure specifies formal reporting relationships of an organization, controls, procedures, authority and the decision-making processes.

Organizational strategies are the actions put in place by an organization to achieve its goals. It should be noted that strategy has a more important influence on structure than structure has on strategy.

In the course of selling a home to a buyer, a broker told the buyer that the home's foundation was "solid as a rock", when he knew for a fact that it was slowly sinking into the landfill on which it was built. In this situation, the broker's conduct would be BEST defined as a

Answers

Answer:

willful misrepresentation

Explanation:

Willful misrepresentation is an intentional act or misrepresentation of facts with an intent to deceive. It is an intentional action taken by one party, which constitutes a breach of representation with an intent or act to mislead the other party to whom such representation was made.

The above scenario is an example of wilful misrepresentation because the broker knew that the foundation of the house was faulty but willfully misrepresented fact by telling the buyer that the home's foundation was 'solid as rock'.

Anderson Corp. began the period with $200 of supplies. During the period, $500 of supplies were purchased. At the end of the period, there were $300 of supplies on hand. What will be the amount of the adjusting entry to record the amount of supplies used

Answers

Answer:Amount of supplies used =$400

Explanation:

Beginning balance of supplies   $200

Supplies purchased                     $500

Ending supplies balance on hand    $300

Amount of supplies used = Beginning balance of supplies + Supplies purchased  - Ending supplies balance on hand

= $200 +$500 - $300

= $400 is amount of the adjusting entry to record the amount of supplies used in Anderson Corp.

Physical units to be accounted equals A : units started into production plus units in ending work in process inventory. B : units started into production plus units in beginning work in process inventory. C : units started into production less units in beginning work in process inventory. D : units completed and transferred out plus beginning work in process inventory.

Answers

Answer:

B : units started into production plus units in beginning work in process inventory.

Explanation:

If a Company uses process costing, the units to be accounted for are the units  that were in production during the period.

Units in production comprises of units in beginning work in process still to be completed as a result of previous process plus the units started into production during the period.

"A 25-year old client with a low risk tolerance wishes to invest in bonds. The client has invested in equities before, but has no experience investing in bonds. The BEST recommendation would be:"

Answers

Answer: AA-rated short-term bonds

Explanation:

The options to the question are:

A. BB-rated short-term bonds

B. BB-rated intermediate-term bonds

C. AA-rated short-term bonds

D. AA-rated long-term bonds

From the question, we have been informed that the client has a low risk tolerance and wants to invest in bond.

Based on this scenario, to reduce the risk of the interest rate risk, it should be noted that short-term maturities are more appropriate than choosing the long-term maturities.

Therefore, the best recommendation will be AA-rated short-term bonds.

Jessica invested her savings in two investment funds. The amount she invested in Fund A was $8000 less than the amount she invested in Fund B. Fund A returned a 2% profit and Fund B returned a 8% profit. How much did she invest in Fund B, if the total profit from the two funds together was $2140

Answers

Answer:

23,000

Explanation:

Jessica invested her savings in two investment funds

The amount that she invested in fund A was $8000 than the amount invested in fund B

A + B = -8000.......... equation 1

Fund A returned 2% profit and fund B returned 8% profit

2/100= 0.02 , 8/100= 0.08

0.02A + 0.08B= 2140.............equation 2

From equation 1

A -B= -8000

A= -8000+B

Substitute -8000-B for A in equation 2

0.02(-8000+B) + 0.08B= 2140

-160+0.02B + 0.08B= 2140

-160 + 0.1B= 2140

Collect the like terms

0.1B= 2140+160

0.1B= 2300

B= 2300/0.1

B= 23,000

From equation 1

A-B= -8000

A= -8000+B

Substitute 23,000 for B

A = -8000+23000

A= 15,000

Hence Jessica invested 23,000 in fund B

In an addendum to the purchase and sale contract, the seller agrees to paint the house before conveying the house to the buyer. The weather changes, and the seller is unable to finish painting the house before closing. This is an example of _______.

Answers

Answer:  Partial performance

Explanation:

Partial performance is described as the completion of a job that forms a portion of a contract.

Here,  the seller agrees to paint the house before conveying the house to the buyer. The weather changes, and the seller is unable to finish painting the house before closing.

This indicates a part of job is done.

Hence, this is an example of partial performance.

The introduction of automatic elevator equipment allowed firms to handle the movement of people in a multistory building at less cost, thus decreasing the demand for elevator operators. The best explanation for this change is that the Multiple Choice marginal product of elevator operators was equal to its price. marginal product of automatic elevator equipment was equal to its price. marginal product of automatic elevator equipment divided by its price was greater than that for elevator operators. marginal product of elevator operators divided by its price was greater than that for automatic elevator equipment.

Answers

Answer:

The marginal product of automatic elevator equipment divided by its price was greater than that for elevator operators

Explanation:

Since in the question, it is mentioned that the automatic elevator introduction permit the firms to handle the movement of the people at least cost also it declines the demand for the operators of the elevator

This represents that the marginal product of elevator equipment would be divided by price and also it is more than for operators who are dealing in elevators

An arrangement where a property developed by the seller is sold to a buyer. The seller retains occupancy of the premises by signing a lease with the buyer. The seller, now the tenant, pays taxes, utilities, insurance and operating costs. This is called a ___________. This is a common practice for Walmart and Rite-Aide and many other businesses Group of answer choices sale rental agreement net lease investment lease-purchase option nome of the other answers

Answers

Answer:

B. net lease investment

Explanation:

The net lease investment is a type of commercial real estate arrangement where the tenant of a property is expected to pay rent along with either taxes, insurance, and maintenance. There are different types of net lease agreements. We have the;

1. Single net lease agreement where the tenant is expected to pay rent along with property taxes. The landlord pays for the operating costs of the property.

2. Double net lease agreements where the tenant, also known as lessor pays the rent, property taxes, and insurance. The landlord pays for the operating costs.

3. The triple net lease agreements where the tenant pays the rent, property insurance, and taxes, as well as the operating costs of maintenance.

Most businesses in the United States such as FedX, McDonald's, Walmart, and many others use this kind of real estate arrangement.

Which of the following statements is FALSE? Inventory sourcing occurs when an order is created. Inventory sourcing occurs when an order is changed. Inventory sourcing occurs when a quotation is made. Inventory sourcing occurs when the delivery document is created

Answers

Answer:

Inventory sourcing occur when a quotation is created

Explanation:

Inventory sourcing is a process of inventory replacement that involves locating and selecting suppliers of inventory based on certain criteria.

The process of inventory sourcing includes creating an order ,changing an order and creating the delivery document .

Submitting a quotation is a pre - sourcing activity that may not necessarily lead to sourcing except the prices and other terms contained in it is in line with the business strategy of the buying organization.

Which transaction or event required the journal entry: debit Interest expense for $250 and credit Interest payable for $250

Answers

Answer:

Loan or loan note with a specific interest rate

Explanation:

When the firm has taken a loan from the bank or issued loan notes which have the specific interest rate or coupon rate respectively paid in arrears. The interest expense will accrue each year with the entry by debiting the interest expense and crediting the interest payable and when the interest will be paid the entry will be credit cash and debit interest payable.

roker Bill takes his broker course and passes it. He applies and receives his license on time. He pays all the appropriate fees and he begins his work. (He does not have a four-year degree in real estate.) He is not sure which course or courses he must take to renew his license the first time. What must Broker Bill do?

Answers

Answer: Broker Bill must complete the two 30 hour courses which will be equal to 60 hours post license course

Explanation:

From the question, we are informed that Bill takes his broker course and passes it and that he applies and receives his license on time and then pays all the appropriate fees and he begins his work even though he does not have a four-year degree in real estate.

We are further told that he is not sure which course or courses he must take to renew his license the first time. Broker Bill must complete the two 30 hour courses which will be equal to 60 hours post license course

If a for-profit firm that has paid out record bonuses to its executive every year while underfunding contributions to unionized workers' pensions required under the collective agreement then attempts to reduce workers' pension entitlements, the union members will most likely

Answers

Complete Question:

If a for-profit firm that has paid out record bonuses to its executive every year while underfunding contributions to unionized workers' pensions required under the collective agreement then attempts to reduce workers' pension entitlements, the union members will most likely

Group of answer choices

A. enter into collective bargaining.

B. be unable to defend against this action.

C. take defensive strike action.

D. receive higher wages instead.

Answer:

C. take defensive strike action.

Explanation:

If a for-profit firm that has paid out record bonuses to its executive every year while underfunding contributions to unionized workers' pensions required under the collective agreement then attempts to reduce workers' pension entitlements, the union members will most likely take defensive strike action.

A for-profit firm can be defined as a business entity that is solely focused on making or earning profits rather than public interests.

In this scenario, the union members (workers) have been denied their pension benefits and even attempts to reduce the amount. Thus, to express their displeasure and reservations to the unsatisfactory behavior of the for-profit firm, the union members will most likely take defensive strike action such as protest so as to defend their common interests.

At his last review, Lazar was told that his reports succeed at projecting a positive tone, but do not seem objective enough. Lazar has asked you, as a trusted colleague, to give him advice on how to improve that aspect of his work. Which of the following will you tell him?A. Use bulleted or enumerated lists to reduce the density of information.B. Provide information, analysis, and advice that is sound, reliable, and unbiased.C. Include an executive summary that provides the quick story of the report.D. Provide a well-designed table of contents.E. Use tables and charts in your report to represent numerical information.

Answers

Answer:

B

Explanation:

One of the top characteristics of a good report is that it must maintain a good degree of objectivity .In a good report , enthusiasm and positive emotion should not overtake the judgement of the writer. This means that it must tot be biased in any way and at the same time delivers the desired objective.

Advising Lazar on improving his report , he has to provide information, analysis, and advice that is sound , reliable , and unbiased.

3. What does the segment suggest to guard against employee misuse of workplace technology? *

Answers

Answer:

Economics

Explanation:

Question 2 of 10
Which of the following skills do employers in any field expect their employees
to have?
O A. Ability to use a cash register
O B. Ability to lift at least 30 pounds
O c. Ability to use word processing software
O D. Ability to provide a healthy work environment

Answers

Answer:

D. Ability to provide a healthy work environment

Explanation:

The most important skill needed by employers in any field is the ability to provide a healthy work environment. Irrespective of any expertise, a good and healthy work environment is needed for employees so that they can be productive. A healthy environment leads to reduce in injuries and illness thereby providing a stress free environment which in turn leads to an increased productivity.

Match the ICS Functional Areas with their descriptions.

a. Incident Command

b. Operations

c. Planning

d. Logistic

e. Finance/Administration

f. Intelligence/Investigation

1. Supports the incident action planning process by tracking resources, collecting/analyzing information, and maintaining documentation.

2. Sets the incident objectives, strategies, and priorities, and has overall responsibility for the incident.

3. Ensures that all intelligence/investigations operations and activities are properly managed, coordinated, and directed.

4. Conducts operations to reach the incident objectives. Establishes tactics and directs all operational resources.

5. Monitors costs related to the incident. Provides accounting, procurement, time recording, and cost analyses.

6. Arranges for resources and needed services to support achievement of the incident objectives.

Answers

Answer:

1. Planning.

2. Command.

3. Intelligence/Investigation.

4. Operations.

5. Finance/Administration.

6. Logistics.

Explanation:

ICS is an acronym for incident command systems and can be used for planned events, as well as for emergencies and coordinated responses in various circumstances or organizations.

The five (5) major functional areas of the incident command system (ICS) are;

1. Planning: Supports the incident action planning process by tracking resources, collecting/analyzing information, and maintaining documentation.

2. Command: Sets the incident objectives, strategies, and priorities, and has overall responsibility for the incident.

3. Intelligence/Investigation: Ensures that all intelligence/investigations operations and activities are properly managed, coordinated, and directed.

4. Operations: Conducts operations to reach the incident objectives. Establishes tactics and directs all operational resources.

5. Finance/Administration: Monitors costs related to the incident. Provides accounting, procurement, time recording, and cost analyses.

6. Logistics: Arranges for resources and needed services to support achievement of the incident objectives.

a printed pamphelt that describes goods for sale is called a?

Answers

Answer:

The term "marketing brochure" refers to a small document, or pamphlet, which describes and promotes various products or services to be marketed.

what is the best business organization for annabeth’s new company?

a corporation, because she will need financing to get started.

a sole proprietorship, because the business is small and simple to operate.

a partnership, because she lacks the skills to make machine parts

a cooperative, because local businesses will be her customers.

Answers

Answer: A Corporation, because she will need financing to get started.

Explanation:

As Annabeth would like to buy a factory to begin making the parts, she would would need a huge cash outlay to get started. By starting a Corporation, she can raise cash easier from the shareholders as well as utilize the knowledge and expertise of others who will join the company to help her in areas she might not be well versed in such as in Accounting or business administration.

Another reason a Corporation would be better is because of the realization of her longer term plans. A Corporation is more likely to expand in the the future which will enable Annabeth realize her dreams of selling to Europe and South America. Indeed, she has a better chance of achieving that sooner rather than later.

Answer:         A)

Explanation:

Coronado Industries has outstanding accounts receivable totaling $6.57 million as of December 31 and sales on credit during the year of $22.6 million. There is also a credit balance of $11000 in the allowance for doubtful accounts. If the company estimates that 5% of its outstanding receivables will be uncollectible, what will be the amount of bad debt expense recognized for the year?

Answers

Answer:

$317,500

Explanation:

The computation of the amount of bad debt expense is shown below:-

Bad debt expenses = (Accounts receivable × Outstanding receivable percentage) - Opening Allowance for doubtful debts

= ($6.57 million × 5%) - $11,000

= $317,500

Therefore for computing the bad debt expense we simply applied the above formula.

Which of the following are good workplace writing
habits? Check all of the boxes that apply.
adjusting the writing style to the audience
and avoiding the use of technical terms if the
reader is not familiar with the subject
checking for errors and misspellings and
making sure to use the correct version of a
word
using abbreviations since everyone in the
office understands their meanings

Answers

The one that exemplifies good workplace writing habits would be:

A). adjusting the writing style to the audience and avoiding the use of technical terms if the reader is not familiar with the subject.

B). checking for errors and misspellings and making sure to use the correct version of a word.

Writing Habits

The above two habits that exemplify good habits of writing at the workplace would be modifying the writing as per the audience.

The technical terms must be prevented before the audience that is not aware of it.

The other good habit is that it is searching for the mistakes that would assist in improving the vocabulary and pronunciation.

Thus, options A and B is the correct answer.

Learn more about "Workplace" here:

brainly.com/question/13838280

Blake racked up three safety violations in one month and was taken off the construction crew and put in the office, meaning he was no longer eligible for overtime. He pled with his boss, saying he needed the money for rent. Citing that Blake's financial situation was not a concern of the company, he was put in the office until he could demonstrate that safety was a priority. This illustrates

Answers

Answer:

Punishment.

Explanation:

In this scenario, Blake racked up three safety violations in one month and was taken off the construction crew and put in the office, meaning he was no longer eligible for overtime. He pled with his boss, saying he needed the money for rent. Citing that Blake's financial situation was not a concern of the company, he was put in the office until he could demonstrate that safety was a priority. This illustrates punishment.

Punishment can be defined as an act of imposing a penalty or consequences on an individual or group of people for flouting rules, guidelines or instructions and any other wrongdoing.

Generally, punishments are used as a moral tool to discourage wrongdoing or unacceptable behaviors being exhibited by people and to serve as a deterrent to others.

Given that he had violated three safety precautions in just one month, the managers action of removing him from the construction site illustrates punishment.

This is an example of positive punishment in the workplace. Punishment is a way of disapproving of certain work behaviors that are unacceptable.

Safety in the workplace is a matter of grave concern. From this punishment that he is made to receive, he would be more safety conscious when he is allowed to join the crew.

The manager's action was very necessary to avoid negative workplace incidents.

Read more on https://brainly.com/question/13025873?referrer=searchResults

Comment created

Firms that follow variable-cost pricing Multiple Choice sell their products at lower net prices abroad than in the domestic market. ensure that no unit of a similar product is different from any other unit in terms of cost. tend to have high variable costs relative to fixed costs. often do so to maximize revenue by matching demand with a limited supply. ensure that each unit bears its full share of the total fixed and variable cost.

Answers

Answer:

Sell their products at lower net prices abroad than in the domestic market

Explanation:

Variable costing is a product costing method where only the variable manufacturing cost like the cost of direct materials ,labor and the variable manufacturing overhead are factored into the cost of production. This does not consider a complete cost like the absorption method of costing and as a result , the final overall cost is lower,

Using variable cost males it possible to sell products at lower net prices abroad compared to the domestics market as the tax laws of various country requires absorption method , hence it is not captures using variable costing.

A citizen in a developing country with a currency policy of convertibility on the current account could engage in all of the following transactions except: Multiple Choice purchase foreign currency in order to import a BMW. sell foreign currency resulting from the exports of manufactured t-shirts. sell foreign currency resulting from the sale of a U.S. treasury bond. purchase foreign currency in order to purchase a U.S. treasury bond.

Answers

Answer: purchase foreign currency in order to purchase a U.S. treasury bond.

Explanation:

Currency convertibility has to do with the degree in which the domestic currency of a particular country can be converted into the currency of another country.

Therefore, a citizen in a developing country with a currency policy of convertibility on the current account could engage in the purchase foreign currency in order to purchase a U.S. treasury bond.

SEC Form S-3 is an optional, short-form registration statement that relies on the incorporation by reference of periodic reports required by the Securities Exchange Act of 1934. Form S-3 offers substantial savings in filing costs over other forms because minimal disclosures are required in the prospectus. The SEC permits the use of Form S-3 by an issuer that

Answers

Complete Question:

SEC Form S-3 is an optional, short-form registration statement that relies on the incorporation by reference of periodic reports required by the Securities Exchange Act of 1934. Form S-3 offers substantial savings in filing costs over other forms because minimal disclosures are required in the prospectus. The SEC permits the use of Form S-3 by an issuer that

Group of answer choices.

A. Does not qualify for Form S-1.

B. Is a seasoned issuer or a well-known seasoned issuer.

C. Does not have stock held by nonaffiliates.

D. Has not had to file Form 8-K during the most recent 2-year period.

Answer:

B. Is a seasoned issuer or a well-known seasoned issuer.

Explanation:

SEC Form S-3 is an optional, short-form registration statement that relies on the incorporation by reference of periodic reports required by the Securities Exchange Act of 1934. Form S-3 offers substantial savings in filing costs over other forms because minimal disclosures are required in the prospectus. The SEC permits the use of Form S-3 by an issuer that is a seasoned issuer or a well-known seasoned issuer.

There are four (4) types of recognized issuers under the Securities and Exchange Commission (SEC) integrated disclosure system, namely;

1. A seasoned issuer: this is an issuer who has a minimum market capitalization of $75,000,000 and has filed for a year at least. They're permitted to use the Form S-3 to report any less details or provide information by reference to other sources.

2. A well-known seasoned issuer: this is an issuer who has a minimum worldwide market capitalization of $700,000,000 and has also filed for a year at least. They're also permitted by the SEC to use the Form S-3.

3. A non-reporting issuer: this is an issuer who is permitted to use the Form S-1 because they're not required to file report under the Securities Exchange Act of 1934.

4. An unseasoned issuer: they are also required by the Securities Exchange Act of 1934 to use the Form S-1.

What are some subject areas PAS prepares students for? Check all that apply.
health science
hospitality
agricultural machinery
information technology
landscape design
food science

Answers

Agriculture machine
Agriculture sales career
College bowl
Crop specialist
Dairy specialist
Employment interview
Livestock specialist
Equine science
Planning for process
Soil science
Speakers for agriculture program

Answer:

Agricultural

Landscape

Food science

Explanation:

Just took the quiz

Zack enters into a contract to buy Olivia’s home. Per the terms of the contract, Zack must put down a $10,000 earnest money deposit and have the property inspected within five days. In reality, he puts down a $12,000 deposit and has the property inspected within two days. This is an example of ______.

Answers

Answer:

performance of a contract

Explanation:

When you enter a contract you can perform your part of the contract, not perform your part of the contract or partially perform your part of the contract. In legal terms, there is no such thing as over performance.

in this case, Zack performed his part of the contract. Him making a slightly higher deposit or getting the inspection done before the due date, will not alter the total consideration of the contract, e.g. selling price will remain unchanged and the house will be the same one.

1.
True or False: How quickly other drugs reach the bloodstream varies depending upon how the drug is put into the system and the type of drug, the age of the user, and the weight of the user.
True
False

Answers

Answer:

true is the answer i think

Smith Company learned that several other shippers in its hometown had customers located in the same markets that it serves. With this information, Jones should investigate the possibility of:

Answers

Answer: Pooled delivery consolidation

Explanation:

Pooled delivered consolidation is a scenario where group of shipments bound for the same region would have shipped less than tuckload carrier are pooled into the same trailer and are shipped to key markets then desolved to make the final aspects of the delivery. Smith should investigate a possibility of pooled delivery consolidation.

EFT, Inc. EFT, Inc. wants to empower and engage its employees. They have several teams consisting of highly skilled employees and no one person on these teams has a specifically assigned position. Instead, employees lead each other as the occasion arises so there is no formal hierarchy or organizational chart. This type of leadership is most effective when:

Answers

Answer:

This question is incomplete, the options are missing and the final sentence is written wrong.

The options are the following:

a) People-oriented leadership

b) Managerial leadership

c) Shared leadership

d) Servant leadership

And the correct answer is the option C: Shared leadership

That type of leadership is known as Shared leadership.

Explanation:

To begin with, the "Shared leadership" is the name given to a style of leadership that is used in the companies with the purpose of letting the members of a team to work together as there were no leader at all but instead every member lead each other as the occassions arises and the project goes on. Therefore that this style matches with the description given in where the team members help each other to resolve the situations that evolve as long as the project keeps to continue.

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The nation emerged victorious from both wars, but with greatlydepleted resources.O B. The nation failed to accomplish its objectives in either war butgained valuable allies.C. The nation emerged from both wars with an expanded influence onworld affairs.D. The nation overextended itself in both wars and returned to anisolationist stance. word combinations path