CH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must:

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Answer 1

If investigators are complying with ICH E6 guideline, they must: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records.

What are ICH E6 guidelines?

In order to discuss and produce ICH recommendations, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory agencies and the pharmaceutical sector. Beyond the membership and regional representation of ICH itself, the ICH E6 Good Clinical Practice (GCP) Guideline is extensively used by clinical trial researchers and has a substantial effect on trial participants and patients.

The ICH E6 guidelines do not have the force of law in the U.S. and are not regulations.

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Related Questions

Frank is overweight and seems unable to stick to any diet. Although his diet efforts suggest that he wants to lose weight, he denies it and says that he is happy with his body the way it is. Frank is trying to reduce his feelings of

Answers

Answer:

cognitive dissonance

Explanation:

his actions are not matching his emotions, so he is trying to make them match each other

Nancy Jones called wanting an appointment with her primary care provider, who is one of six physicians in the department. She has a mole that has changed shape and size. Nancy vocalized her concern regarding skin cancer. The schedule is pretty full and the next available appointment is one month away. It is important for the receptionist to display sensitivity to the patient when scheduling the appointment and to utilize additional options if the appointment time does not meet the patient’s needs. Your posting should discuss behaviors that would show the receptionist is displaying sensitivity to Nancy and describe possible options that the receptionist might investigate to have the patient seen sooner.

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Sensitivity on the part of the receptionist is necessary, to investigate if the problem is causing discomfort, and if an appointment is urgently needed because it is a disease that can bring greater problems to the patient's health.

What should the receptionist do?

In this specific case, she should be able to fit the patient in as soon as possible, because if it is a cancer of the skin, in a month it can compromise the patient's health and can lead to her death.

With this information, we can conclude that the hospital receptionist must provide information to patients, schedule appointments, organize the care protocol, as well as answer questions in general, always available to respond to the various demands of the sector.

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Drug manufacturers label certain medications in a particular way to distinguish between two that look or sound alike, this is called:

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Drug manufacturers label certain medications in a particular way to distinguish between two that look or sound alike, this is called: Tall Man Lettering.

FDA [Food and Drug Administration] makes a rule for naming similar sounding or similar looking drugs in a unique way to avoid confusion and mistaken administration of wrong drug cases. This practice is named Tall Man Lettering.

Tall Man Lettering: It can be described as a unique process of writing a part of the names of the drugs on the packing in upper case letters which helps people to differentiate easily between the same sounding or look-alike drugs. This practice is proven to reduce medication errors.

Example: In tall man lettering, “PREDNISONE” and “PREDNISOLONE” should be written as "predniSONE" and "predniSOLONE", respectively.

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You have set up an appointment for an in-home sales presentation with Mrs. Fernandez, who expressed interest in the Medicare plans you represent. In preparation for the sales presentation, what must you do?

Answers

Sahahajaiwiwkwmenbenxicixkdndndndkdkdod

Answer:before conducting the presentation, obtain, and document having obtained her permission to visit.......

Explanation:

Nutrient recommendations can be gender specific. Which nutrient do young-adult females need in greater amounts than do young-adult males

Answers

Young adult females need Iron in greater amounts than young adult males.

Nutrients required by young female adults:

To maintain a healthy body and well-being, intake of a healthy diet is of importance for every person. These nutritions differ from male to female. In males, there is more requirement for calories because of their large body size because of the muscles mass. They need more energy to do the work and thus intake more calories in their diet.

Females require more intake of vitamins, calcium, and iron in their diet. As they have hormonal changes in their life span. These hormonal changes occur every month during menstruation, pregnancy, and menopause. During menstruation every month there's a heavy loss of blood which makes them weak and sometimes anemic due to a decrease in the level of iron. At old age, women are more prone to osteoporosis due to the decreased level of vitamin D and calcium. So, to avoid these conditions at a young age female adults should consume more diet, having calcium, iron, and vitamins.

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For an active person who is maintaining weight, carbohydrate should make up _______ of a daily diet.

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(55-65 percent)replace at its highest heat rate

How are the vast majority of foodborne illnesses transmitted in our current food system?.

Answers

Answer:

Most often, food is contaminated by infected food handlers. Food may also be contaminated if it is grown in or irrigated with water contaminated with norovirus, as has been shown with oysters, lettuce, and raspberries.

Explanation:

Mr. Valdez has been diagnosed with type 2 diabetes, he has high blood pressure, he smokes 10 cigarettes a day, he is sedentary, is 50 pounds overweight, has a low HDL cholesterol level, and an elevated LDL cholesterol level. He is therefore

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Mr. Valdez has been diagnosed with type 2 diabetes, he has high blood pressure, smokes 10 cigarettes a day, is sedentary, is 50 pounds overweight, has a low HDL cholesterol level, and has an elevated LDL cholesterol level. He is therefore at high risk for heart disease.

The Acceptable Macronutrient Distribution Range recommendation is that 20 to 35 percent of your daily calories should come from fat.

The 2015–2020 Dietary Guidelines for Americans recommends limiting calories from saturated fats to less than 10% of the total calories you eat and drink each day. That's about 200 calories for a 2,000-calorie diet.

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Bryant has skin cancer and is being treated with an antimetabolite, which routes are available for administration ____.

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If Bryant has skin cancer and is being treated with an antimetabolite then IV, topical, and oral forms are available.

Since antimetabolites prevent DNA synthesis, which in turn prevents cell division and tumor growth, they can be utilized to treat cancer.Because cancer cells take longer to divide than other types of cells, stopping cell division is more harmful to tumor cells than to other types of cells.Some antimetabolites are offered as oral liquids or pills that can be taken every day. Some medications are injected through an intravenous (IV) line that a medical professional places in a vein.Antimetabolites for treating skin cancer can be found in topical creams that you apply once or twice daily to the afflicted area. It's frequently a particular form of IV line called a mediport that is positioned in a large, central vein.

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a healthy 32-year-old woman is scheduled for elective excision of a nevus from her right shoulder. which method of anesthesia is likely to be used

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Explanation:

nevus anesthesia I think not really sure

It is prescribed to use local anesthesia for the 32 yr old healthy women for elective excision of a nevus from her right shoulder.

What is an anesthesia?Anesthesia is a medical treatment that prevents patients from feeling pain during procedures like surgery, certain tests, tissue sample removal and dental care.Four main categories of anesthesia used: General anesthesia, Regional anesthesia, Sedation (called "monitored anesthesia care") and Local anesthesia.Local anesthesia blocks the transmission of pain impulses to the brain; as a result, the patient cannot feel pain but is able to move and feel pressure.Sometimes patients may choose which type of anesthesia will be used.

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Which feature of influenza viruses is the reason why vaccines against them have to be produced each year

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The feature of the influenza virus which is the reason behind synthesis of new vaccines for influenza every year is antigenic drift.

Antigenic drift is a phenomenon by which mutations give rise to genetic variations in pathogenic agents like viruses, which changes the viral surface proteins of the virus. These changes in the viral surface proteins in the antigen leads to the generation of new variations. These variations are new to the immune cells in the body and trigger them with different signals every time they infect a host.  The best example to study this effect is the influenza virus which has numerous variations like influenza A, B, C and D. Thus, the influenza virus has to be produced or updated every year.

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Ideally, you should consume _______-rich foods and beverages as soon as tolerable after your workout.

Answers

potassium it’s your nutrients

What were the results of the classic study that examined the role of personal control over their environment on nursing home residents

Answers

This classic study was done by Ellen Langer and Judith Rodin in early 1980s.

This was performed to examine the role of personal control over their environment on elderly nursing home residents.

In the early stage of this study, residents were divided into two groups at random, with one group receiving greater opportunity for personal responsibility than usual.

After 18 months of this study, it was seen that people who were given control and personal responsibility had better health than those for whom control remained the same; these residents also had more deaths.

So basically the result of this study was that:

Elderly nursing home residents with a sense of control over their environment are healthier than elderly nursing home residents without a sense of personal control over their environment.

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Jack, a 33 kg dog, needs pain medication at a dose of 5mg/kg. The pain medication’s concentration is 50mg/mL. How many mg does he need?

Answers

Hello!

To find mass of medication :

⇒ 33 kg × 5 mg/kg

⇒ [tex]\fbox {165 mg}[/tex]

He needs 165 mg of pain medication.

Maintaining a record of incidents and corrective actions related to infections is assigned under Final Rules to:

Answers

Maintaining a record of incidents and corrective actions related to infections is assigned under Final Rules to: The infection control program

The infection control program:

This regulation's goal is to ensure that the facility creates, implements, and maintains an infection prevention and control program to stop, identify, and, to the greatest degree practicable, limit the onset and spread of disease within the facility. The program will:

Perform surveillance and investigation to prevent, to the extent possible, the onset and the spread of infection; Prevent and control outbreaks and cross-contamination using transmission-based precautions in addition to standard precautions; Use records of infection incidents to improve its infection control processes and outcomes by taking corrective actions, as indicated; Implement hand hygiene (hand washing) practices consistent with accepted standards of practice, to reduce the spread of infections and prevent cross-contamination.

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Whether prescribing an antibiotic for a child with acute otitis media or not, the parents should be educated about:

Answers

The parents should be educated about providing adequate pain relief for at least the first 24 hours  when prescribing an antibiotic for a child with acute otitis media.

Acute otitis media

Acute otitis media (AOM) frequently occur in children between the ages of 6 and 36 months. Symptoms consist mainly of otalgia, fever, irritability, anorexia and diarrhoea. It is usually a self-limiting disease; complications are rare, and antibiotics are usually not necessary, unless the course is irregular.

Amoxicillin, trimethoprim plus sulfamethoxazole, or erythromycin plus sulfasoxazole are the first-choice antibiotics for AOM.

Early treatment with antibiotics might reduce the severity of pain, but the majority of children feel better within 24 h, regardless of antibiotic treatment.

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The parents of a child recently diagnosed with sickle cell anemia ask what can be done to avoid a sickle cell crisis. What should be included in the medical management of sickle cell crisis

Answers

Immunizations and daily doses of penicillin to help prevent sickle cell anemia.

What is sickle cell anemia?

One of the genetic diseases known as sickle cell disease is sickle cell anemia. Red blood cells, which deliver oxygen to every region of the body, are affected in terms of structure.

Typically rounded and flexible, red blood cells can flow through blood veins with ease. Red blood cells with sickle or crescent shapes are characteristic of sickle cell anemia. Additionally, these sickle cells develop a hard and sticky coating that can hinder or delay blood flow.

The sole treatment for sickle cell disease is a stem cell or bone marrow transplant, although these procedures are not carried out very frequently due to the high risks. Bone marrow, a spongy substance located in the center of some bones, is a particular cell type that produces stem cells.

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Why is it necessary for healthy vegetarian to combine different plant foods or eat some eggs or milk products

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It  is necessary for vegetarians to combine different plant foods or eat some eggs or milk proteins to meet the nutritional requirements.

Nutritional requirement is the basic amount of nutrients required by the human body. These nutrients should be taken by an individual for the proper functioning of all the processes and for protection against various diseases caused due to nutrient deficiency,

By the consumption of various plant foods, people can obtain proteins, fats, carbohydrates and minerals .

Vegetarians also require to add some eggs or milk proteins to their diet so that they receive all the important nutrients that are required to  remain active and healthy.

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A high dietary intake of protein will also increase an athlete's need for: Low glycemic foods Fluid Fat Essential amino acids

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When consuming high protein, it is necessary to increase the intake of water or fluids along with it.

When a high-protein diet is taken, the athlete must increase the consumption of water or fluids as the kidneys are under strain and need to work more to get rid of excess ammonia. Protein is needed by athletes to repair and strengthen their muscles. Ammonia is the bi-product of the metabolism of protein which is converted to urea and is collected by kidneys which is then removed by the body as urine. Increased levels of ammonia can lead to permanent renal damage.

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What happens at a cellular level during organ rejection?

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Organ rejection takes place when your body is subjected to a new organ which is a foreign object and attacks it.

What do you mean by Graft rejection?

Graft rejection may be defined as a process in which a transplant recipient's immune system attacks the transplanted organ or tissue.

Xenograft shows high rejection. This is because it involves the transplantation between genetically distinct members of different species.

The process of organ rejection is initiated by T cells which perform the role of the recognization of a transplanted organ.

If these T cells are activated, it may lead to organ rejection by undergoing clonal expansion, and differentiation of the effector cells, which together lead to the obliteration of the tissues.

Therefore, organ rejection takes place when your body is subjected to a new organ which is a foreign object, and attacks it.

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Please provide a brief example for a patient who can sustain harm due to a inadequate communication from his provider

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Answer:

Inadequate communication can compromise a patients safety and can cause patient dissatisfaction.

Which clinical manifestation does the client who has polycythemia have in common with a client with prolonged anemia

Answers

The main clinical manifestations of a patient suffering prolonged anemia are weakness of the immune system, fatigue and shortness of breath.

What is anemia?

Anemia is a condition associated with the lack of red blood cells and/or hemoglobin proteins in the bloodstream.

Hemoglobin is a fundamental protein required to transport oxygen during cellular respiration, thereby signs of anemia are associated with this insufficiency in this function.

In conclusion, the main clinical manifestations of a patient suffering prolonged anemia are weakness of the immune system, fatigue and shortness of breath.

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You are on the phone with a patient’s insurance company. What form would you refer to from the patients record to make changes to the insurance information?

Answers

Answer:

Patient information form

Explanation:

If your family provides affirmation, they Select one: a. meet your physical needs. b. make you feel appreciated and supported. c. teach you health skills. d. set limits on your behavior.

Answers

If your family provides affirmation, they make you feel appreciated and supported.

Positive words called affirmations can assist you in battling and overcoming self-defeating and pessimistic ideas. You can begin to make constructive changes when you repeat them frequently and trust in them.Receiving compliments on your achievements from family, no matter how small, can help you feel more confident. A person feels happy when they are respected. A person can perceive things differently if they are joyful.Your ability to modify your negative thought patterns and replace them with good ones is something that affirmations may help you with. They can also help you focus on attaining your life objectives.

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When assisting a patient in learning
to use a walker, it is important to

Answers

Answer:

stand behind him and use a transfer belt

In a means-end chain for milk, the calcium content of milk leads to healthier bones, which leads to a display of wisdom and a comfortable life free of osteoporosis. The display of wisdom and a comfortable life component of the means-end chain is the:

Answers

The display of wisdom and a comfortable life component of the means-end chain is the Product attribute.

Product attributes are properties that define a particular product and influence consumers' purchasing decisions. Product characteristics can be tangible (or physical) or intangible (or intangible).

The three elements of product attributes (overall product quality, actual product features, how features are integrated with each other, and what the product looks like) are very important decisions for product success.

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Using the ICD-10-CM code book, assign code(s) for the following diagnosis: Initial encounter for injury sustained due to nightgown catching fire while cooking breakfast in the kitchen of her mobile home.

List the ICD-10-CM code to report the cause of injury.

Answers

The ICD-10 code for injury sustained due to the shirt on fire is T29 - Burns and Corrosion of Multiple Body Regions

List the ICD-10-CM code to report the cause of the injury.

ICD 10 - T29 Burns and corrosion of multiple body regionsICD 10 - T29.0 Multiple burns, degree not specifiedICD 10 - T29.1 Multiple burns, not to mention burn(s) exceeding first degree

What is ICD 10?

In summary, the acronym covers the classification and coding of diseases. It is of a wide variety of

signssymptomsabnormal featurescomplaintssocial circumstancesand also external causes for injury or illness.

It is also worth remembering that the acronym is used worldwide as the medical standard for cataloging medical diagnoses.

With this information, we can conclude that the ICD 10 is the code  International Classification of Diseases.

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How did the CEO's leadership style impact the outcome of the EHR implementation

Answers

As a result, there was friction inside the organization as certain employees supported the EHR system while others did not. This is further explained below.

What is leadership style?

Generally, A leader's style is how they go about making decisions, carrying them out, and inspiring their team.

In conclusion, The CEO of the healthcare system displayed an Autocratic Leadership style during the EHR selection process, choosing the system on his own and announcing the implementation date to staff members in the firm's belief that workers are more productive when given explicit instructions and strong leadership.

As a consequence, there was friction inside the organization as certain employees supported the EHR system while others did not.

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What is the percentage of a Healthcare Provider contracting HIV from splashing of HIV infected blood into the eyes or mouth?

Answers

There is a 0.1% chance that a healthcare provider could be infected by splashing of HIV-infected blood into the eyes or mouth.

The human immunodeficiency virus or HIV causes AIDS (acquired immunodeficiency syndrome), which is a condition that affects the immune system and its ability to fight diseases. The transmission of this disease occurs when  body fluids like blood, semen and vaginal fluids are exchanged between two individuals. The HIV virus affects the CD4 cells of the immune system by invading these cells and creating copies of the cell. This affects the ability of cells of the immune system to fight antigens and pathogens in the body.

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how many mg must be used to prepare 1L of a 4% solution?

Answers

Answer:

40 mg??

Explanation:

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She randomly selects 550 housing units in her county and finds that 130 of the housing units are vacant. Conduct an appropriate hypothesis test for the supervisor and state your conclusion. A retail shop accepts only cash or checks. Suppose that 60% of its customers carry cash, 59% carry checks, and 77% carry cash or checks (or both). What is the probability that a randomly chosen customer at the shop is carrying both cash and checks? What was the main goal of the National Woman Suffrage Association? A. To provide better working conditions for women B. To acquire the right to vote for women C. To prevent domestic abuse of womenD. To protect pregnant women from being discriminated in the work place When motivation is argued to be (1) an internally propelled response rather than (2) a response to elements of the physical, mental, and social environment, the contrasting theories are ________ stocks were responsible for the huge increase in stock prices in the period between 1982 and 2000. Group of answer choices Technology Manufacturing Clothing Automobile Banking Cretia Robritti discovered that the purpose of asset allocation is to ensure that the investor is ________, generally with holdings in several different ________ of investments. Question 19 options: evenly distributed; amounts protected; denominations well diversified; classes well diversified; amounts evenly distributed; classes When testing for tonicity of red blood cells, why were you unable to read the lab manual through the tubes containing hypertonic or isotonic solution The method of judicial selection (a model not used by Texas) in which a nominating committee appointed by the governor nominates candidates for a judicial vacancy, the governor then appoints one for a term of office and during the next general election he/she runs unopposed on a nonpartisan ballot is called Hydrogen gas can be produced by the reaction of magnesium metal with hydrochloric acid by the reaction below. mg 2hcl mgcl2 h2 if 4.00 g of mg is reacted with 3.20 g of hcl, what is the limiting reactant? mg hcl ista father has an age that is 2 years greater than four times her age.The sum of their ages is 57 yeasrs A certain drug decays at a rate of 10% per hour. If the initial dose is 700 mg, how much left in a persons system after 5 hours? Drag each condition to the correct location on the table. Match each condition to the number of triangles that can be constructed to fit the condition. condition A: one side measuring 4 inches, another side measuring 8 inches, and a third side measuring 10 inches condition B: one angle measuring 60, another angle measuring 40, and a third angle measuring 90 condition C: one side measuring 4 inches, another side measuring 8 inches, and the angle between them measuring 70 condition D: one side measuring 5 inches, another side measuring 7 inches, and a third side measuring 12 inches condition E: one angle measuring 30, another angle measuring 80, and the length of the included side measuring 8 inches condition F: one angle measuring 40, another angle measuring 80, and a third angle measuring 60 The following are the temperatures inC for the first 12 days of January:-5.5, 6, -1.5, 3, 4, -2.5,0, 6.5, -3, 2.5, -1, 5.5What is the median temperature forthose 12 days?Give your answer as a decimal.ABC CheckXI Jack, a 33 kg dog, needs pain medication at a dose of 5mg/kg. The pain medications concentration is 50mg/mL. How many mg does he need? The hydronium ion concentration of a solution is 2.4 x 10-4.a. Calculate the pH of the solution.b. Calculate the pOH of the solution.c. Calculate the hydroxide ion concentration of the solution 100 POINTS HELP In this unit, you explored the theme of historical speeches and examined the guiding question: How do we influence others' beliefs?In this unit, you read and analyzed a variety of speeches and historical documents in which influential figures presented arguments to improve the lives of others. What are some of the techniques these authors used to make their arguments? Which techniques were the most effective?In this unit, you analyzed texts that examined what freedom means of different people living in America, particularly focusing on the analysis of Frederick Douglass' "What is the Fourth of July to a Slave". To what extent do Douglass' words still hold true today? How influential is his document in our current society?You have now analyzed documents and arguments presented by people who influence law and society via their crafting of words and rhetoric. How has this unit shaped your command of words and rhetoric? How will you evaluate the arguments of others in the future based on your study in this unit?