1The site investigator receives a copy of an expedited safety report that represents an increased risk to the study participants

Answers

Answer 1

Answer: File it in regulatory binder

Report to local IRB and Inform all participants.

Explanation:

Answer 2

As a site investigator who receives a copy of an expedited safety report that represents an increased risk to study participants, we are required to report to the local IRB.

Who are Local IRBs?

Local IRBs stands for Institutional Review Board. It can be considered as a person who works in educational institutions and helps in conducting research and only reviews their tests.

Local IRBs are known for their work with academic institutions which conduct research and review only their tests, while central IRBs provide review services for many institutions. Some clinical trial investigators may not have access to a local IRB.

IRBs are administered at the federal level by the Office of Human Research Protections (OHRP) which is an office within the Department of Health and Human Services.

Thus, as a site investigator who receives a copy of an expedited safety report that represents an increased risk to study participants, we are required to report to the local IRB.

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Related Questions

Choose the appropriate step(s) to prepare for the birth of a newborn <32 weeks gestation

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When preterm delivery can be anticipated there may be an opportunity for paediatric staff to discuss intrapartum and postnatal care with prospective parents and colleagues from midwifery and obstetrics. Even if detailed discussion is not possible, relevant historical details should be taken to anticipate problems and prepare appropriately for the arrival of the preterm infant.​infant.

Figure 1
Figure 1
The “inverted triangle” shows how commonly certain interventions are needed
Broadly, the level of resuscitation that may be needed is inversely related to the gestation of the preterm infant. Usually, the approach taken in resuscitating preterm infants of > 32 completed weeks' gestation is the same as that taken for term infants. Most need only basic measures such as drying and stimulation.

A healthy adult requires less than 40 kcalories per kilogram of body weight. A healthy infant requires about ________ kcalories per kilogram of body weight.

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A healthy adult requires less than 40 kcalories per kilogram of body weight. A healthy infant requires about 100 kcalories per kilogram of body weight.

How much energy and protein a baby needs in grams?

Most offers fall around 1-1.5 grams per kilogram of body mass for babies or about 11 grams of protein per day for children 7-12 months old.

For example, a moderate 20 pounds, or 9.1 kg kid would need roughly 9-14 grams of protein.

Thus,  A healthy infant requires about 100 kcalories per kilogram of body weight.

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Older adults might need a Vitamin B-12 supplement because: Question 25 options: their stomach produces less hydrochloric acid they don't eat dairy products as often as they should they drink more fluids and excrete more dilute urine they are at a higher risk of osteoporosis

Answers

Answer:

A! Their stomach produces less hydrochloric acid.

Explanation:

Older folks cannot absorb B-12 from their food as easily as those who are younger. Hyrdolochic acid helps break down and split up proteins. When they get older, their stomachs produce less. Meanwhile, they may have enough B-12 in their diet, they may be falling short on their intake.

As a means of preventing heart disease, taking baby aspirin can ____ that cause(s) heart attack or stroke.

Answers

Answer:

As a means of preventing heart disease, taking baby aspirin can interfere with the process that cause(s) heart attack or stroke.

Explanation:

I'm not sure what the answer choices are so heres an explanation that can help you choose which answer fits best.

Baby asprin helps to interfere with blood clotting, which sounds bad for patients (it is if you cook a lot especially with a knife) it helps the blood to NOT clot in your heart's (or brain's) arteries and prevent blockage. It is in means a preventage towards heart disease and heart attacks.

Hope this helps!

Psychotropic drugs are used to treat psychological disorders by changing brain neurochemistry. Most of the following medications fall within five categories. Match each class of psychotropic drugs with its description.

Answers

The type of psychotropic drugs are not found here but they can be classified into antidepressants, anti-psychotics, anti-anxiety, stimulants, and stabilizers.

What are psychotropic drugs?

Psychotropic drugs are specific medications (drugs) capable of affecting human behavior, emotions, and perceptions.

The type of psychotropic drugs used in a given treatment is variable according to the mental (cognitive) disorder.

In conclusion, the type of psychotropic drugs are not found here but they can be classified into antidepressants, antipsychotics, anti-anxiety, stimulants, and stabilizers.

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tandard safety rules for all healthcare facilities indicate that you should ____. Group of answer choices lyrics

Answers

Answer:

Hold on to handrails when using the stairs

Explanation:

Your friend sprained her ankle during a game of softball and is waiting for her father to come and take her to the doctor. What should she do in the meantime to treat the sprain

Answers

To treat the wound while waiting for medical attention you can elevate, wrap, apply ice and rest the ankle.

Why are these first aid steps important?

These initial steps that you can take while your friend waits for medical attention can be very important. Elevating the ankle reduces the blood flow towards the injured site and can help reduce swelling along with the ice. Wrapping and resting the ankle can help to avoid further injury or dislocation of the ankle.

Therefore, we can confirm that in order to treat the wound while waiting for medical attention you can elevate, wrap, apply ice and rest the ankle.

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All of the following are health risks associated with obesity except: a. sleep apnea. b. diabetes. c. hypertension. d. tuberculosis.

Answers

Answer:

Tuberculosis

Explanation:

Sleep Apnea is associated with it, and so is type 2 diabetes and hypertension.

Studies show that tuberculosis numbers are significantly lower in people with obesity suprisingly.

The option that is not health risks associated with obesity is tuberculosis.

What is obesity?

Obesity refer to a situation in which an individual accumulate excess fat and become overweight which affect his health negatively.

Therefore, The option that is not health risks associated with obesity is tuberculosis.

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If a sterile glove becomes contaminated during the procedure, the best practice for corrective action is:

Answers

Answer:

Must be changed immediately,  the gown cuffs should be considered contaminated because the scrubbed hand passed through them.

Explanation:

When regulatory processes maintain weight by balancing energy intake and energy expenditure, the body is said to

Answers

When regulatory processes maintain weight by balancing energy intake and energy expenditure, the body is said to have reached its set-point.

When energy intake is in balance with energy expenditure weight is?

When energy intake equals energy expenditure, the body is in energy balance and body energy is stable.

Thus,  the body is said to have reached its set-point.

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Hyperglycemia associated with diabetic ketoacidosis is defined as a blood glucose measurement equal to or greater than _____ mg/dl.

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Hyperglycemia associated with diabetic ketoacidosis is defined as a blood glucose measurement equal to or greater than 250mg/dl

What is diabetic ketoacidosis?

Diabetic ketoacidosis is a medical condition that affects people with diabetes. This happen when when the body of a diabetic patient begin to degrade fat at a very high rate that is too fast. The liver breakdown the fat into a fuel called ketones, which make the blood to become acidic.

Therefore, Hyperglycemia associated with diabetic ketoacidosis is defined as a blood glucose measurement equal to or greater than 250mg/dl

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what type of policy would only provide coverage for specific types of illnesses like cancer stroke Etc

Answers

Answer: dread disease insurance

Explanation: dread disease insurance has benefits for only certain types of illnesses. cancer, stroke, etc.

What daily dietary change would most help dave’s reduce his risk for cancer?.

Answers

Answer: Start eating more fruits and vegetables.

Explanation:

Answer:

Eat more Fruits and Vegetables, excercise more often, keep a reasonable weight.

Explanation:

If human milk or infant formula is not available, ____ can provide a safe, nutritious alternative for infants.

Answers

Things with soft textures and high in nutrition like yogurt, advocado or mushed beans/lentils can provide nutrients to infants.

he recipients of the Supplemental Nutrition Assistance Program (SNAP) may use the debit transfer cards they are provided to purchase: a. alcohol b. food-bearing plants c. cleaning items d. toiletries e. tobacco

Answers

The recipients of the Supplemental Nutrition Assistance Program (SNAP) may use the debit transfer cards they are provided to purchase food-bearing plants. Option B. This is further explained below.

What are food-bearing plants?

Generally, any tree that produces tasty fruit is a food-bearing plant, and they are any plants that produce edible fruit.

In conclusion, food-bearing plants are more useful to a recipients of the Supplemental Nutrition Assistance Program.

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Although both conditions share the common characteristic of elevated body temperature, hyperthermia is technically different from fever because ______.

Answers

Hypothermia is when you think that you are really hot, because you are so cold.

One of the greatest dangers facing the premature infant is: Group of answer choices Hypothermia Radiation exposure Exposure to contagions Hyperthermia

Answers

They answer is hypothermia

what assessment history data indicates that a client is at increased risk for developing alzheimer disease

Answers

The alteration in episodic memory, cardiopathies, diabetes, cerebrovascular accidents, genetics can indicate that a client is at increased risk for developing alzheimer disease.

What is the alzheimer's disease?

It is a neurodegenerative disease characterized mainly by memory loss and that causes serious damage to the brain and kills many neurons, affecting the connections between them.

The risk of developing Alzheimer's disease includes several components, first of all, genetic risk, diabetes, stroke, high blood pressure are linked to greater cognitive decline.

Therefore, we can conclude that the alteration in episodic memory, cardiopathies, diabetes, cerebrovascular accidents, genetics can indicate that a client is at increased risk for developing alzheimer disease.

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On the Spreadsheet Report, examine the column for vitamin A (A-RAE). On this day, Elaine's two servings of sweet potatoes provided ______ of the RDA for vitamin A.

Answers

Elaine's two servings of sweet potatoes provided around 2500 mcg of the RDA for Vitamin A.

What do you mean by RDA?

RDA stands for the Recommended Dietary Allowance. It is different for individuals of different age groups as well as gender.

Sweet potato contains beta carotene and Vitamin A. A single sweet potato contains approximately 1200 to 1250 mcg of the RDA.

Therefore, Elaine's two servings of sweet potatoes provided around 2500 mcg of the RDA for Vitamin A.

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Paxil, prozac, and zoloft are examples of ________.

Answers

These are examples of Antidepressants.

what is a unspecific cognitive disability?

Answers

Answer:

Answer: Unspecified intellectual disability is a diagnosis reserved for children over 5 years of age who could not be assessed due to multiple factors, such as a physical disability or co-occurring mental illness. These two diagnoses require reassessment at a later date (1).

Explanation:

Answer:

Unspecified intellectual disability is a diagnosis reserved for children over 5 years of age who could not be assessed due to multiple factors, such as a physical disability or co-occurring mental illness

Explanation:

35-year-old male presents with facial trauma after being struck in the face with a baseball. A teardrop-shaped left pupil is noted on exam. What type of injury is suspected?

Answers

The injury suspected for a 35-year-old male who presents with facial trauma after being struck in the face with a baseball is globe rupture.

What is globe rupture?

Globe rupture refers to a medical condition caused by any damage that disrupts the outer eye membranes due to a physical concussion.

Globe rupture is a serious condition and must be treated in a clinical setting in order to avoid eye loss.

In conclusion, the type of injury that is suspected for a 35-year-old male who presents with facial trauma after being struck in the face with a baseball is globe rupture.

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Using separate colored cutting boards to prep raw meats and to prep fresh fruits and vegetables. This is a good example of what practice

Answers

Explanation:

in the Academy of nutrition and dietetics this practice is known as cutting board safety

The nurse instructs a client on care at home after a laparoscopic cholecystectomy. Which client statement indicates that teaching has been effective

Answers

Answer:

the effective vaccine is glue

A 2-year-old child is admitted with multiple fractures and bruises, and abuse is suspected. Which nursing assessment findings support this suspicion

Answers

Answer:

Difficulty consoling, and Demands for physical closeness

Explanation:

hope this helps

Addison

A client diagnosed with delusional disorder is telling everyone that the client is the president of the United States. This client is exhibiting which type of delusion

Answers

Answer:

Delusion of grandeur

Explanation:

A man awakens after eight hours of normal sleep and has an unbroken snap gauge band. There is a good chance that the man has a:

Answers

A man wakes up after eight hours of normal sleep and has an unbroken range of his blood pressure gauge. There is a good chance that the man has no sleep disturbances.

Snap*Gauge®

Snap*Gauge® is a non-prescription device used by the patient during sleep to determine if a patient breaks pre-set snap-gauges with different release-force constants. The number of brands broken will indicate the intensity of the patient's nighttime erections.

With this information, we can conclude that a man wakes up after eight hours of normal sleep and has an unbroken range of his blood pressure gauge. There is a good chance that the man has no sleep disturbances.

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Which nursing action is a priority for a client with a spinal cord injury who has developed sudden autonomic dysreflexia

Answers

Answer: Place in a sitting position

Explanation: Clients with spinal cord injuries are at an increased risk for developing autonomic dysreflexia. Autonomic dysreflexia is a condition in which the client has very high BP. 1st step is assist the client into a sitting position because it naturally reduces BP.

The first major antipsychotic drug to be introduced was ________ Blank; it was used to treat ________ Blank.

Answers

Answer:

The first major antipsychotic drug to be introduced was Chlorpromazine; it was used to treat psychotic disorders such as schizophrenia or manic-depression in adults.

Explanation:

The term multiple sclerosis and atherosclerosis both refer to.

Answers

Answer:

the slowing down of signalst to the nervs

Explanation:

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