Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an investigational new drug is used?

Answers

Answer 1

Answer: D. Annual Safety Report

Explanation:

The FDA requires that when there is a chance that an adverse effect might occur in a clinical trial, that it is included in certain documents.

It is to be included in an investigator brochure to ensure that the investigators are aware.

Protocol documents should also have the events disclosed and the the clinical participants should be aware of it in the Informed Consent Form that they sign.

An Annual Safety Report is not a primary source document in the first place so is the wrong option here.


Related Questions

Is ligamentum sacroiliaca posteriora the same as ligamentum sacroiliaca dorsalia?

Answers

Answer:nop

Explanation:

N o p E Ecause rhe upper part short posterior sqxroilix litqnebr

Which of the following is a water-soluble vitamin?

Vitamin H
Reservatrol
Beta Alanine
Vitamin C

Answers

Vitamin C because it is a water-soluble

Pharmacy Polices and Procedures

The look-Alike and Sound-Alike Drugs Policy is based on whose standards?
Select all that apply.

a. DEA
b. FDA
c. OSHA
d. Red River Pharmacy
e. ISMP

Answers

Answer:

B. FDA

E. ISMP

Explanation:

I calculated logically

Answer:

B. FDA

E. ISMP

Explanation:

edg '22

Approximately how many healthcare workers in America have acquired hub on the job

Answers

Answer:

129

Explanation:

THE NERVOUS SYSTEM!
Plz someone help me 200words PLZ DO HELP ME ANYPNE WHO KNOWS THIS ITS DUE TODAY!!!! :,)

Answers

Answer:

We cannot help because we don't know what your module videos are about...

Explanation:

The teacher seems to be very strict that the info only comes from those specific units/assignments. I'm sorry-

sorry we can’t see the video

The different between hypothermia and hyperthermia

Answers

Answer:

Hypothermia is being really cold and hyperthermia is being really hot

Explanation:

Answer:

hypo cold hyper hot

Explanation:

Parental pressure for children to excel may be related to:

Answers

Answer:

Explanation:

Maturation and culture

Parental pressure for children to excel may be related to: stress.

What is parental pressure?

Parental pressure for children to excel may be related to various factors, including cultural and societal expectations, parental anxiety or desire for success, perceived benefits for the child's future, and even the parent's own unfulfilled ambitions. Some potential effects of this pressure on children may include:

Stress and anxiety: Children may feel overwhelmed by high expectations and constant pressure to perform, leading to stress and anxiety.

Fear of failure: Children may become overly focused on achieving success and develop a fear of failure or disappointment.

Strained relationships: Pressure to excel can create tension and conflict between parents and children, and may strain the parent-child relationship.

Burnout and loss of interest: Too much pressure can lead to burnout and loss of interest in the activity or task, leading to a decreased motivation to excel.

Negative impact on mental health: Prolonged exposure to parental pressure can contribute to mental health issues such as depression, anxiety, and low self-esteem.

Learn more about parental pressure, here:

https://brainly.com/question/28272334

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Why are 40% of car accidents related to drinking?

Answers

Answer:

because they like to be at party and they like to drink and drive

Explanation:

im just a smart kid

When under influence of driving when drunk their mind doesn’t tell them this is wrong their mind will tell their body they don’t care what they do so they’ll drive when drunk and risk their lives and people around them

Does Someone Want To Freestyle With Me

Answers

Answer:

sure :)

Explanation:

ribbit,

tsu-chan (^◡^)

Answer:I’m gonna live my life like a king all this bling, all these racks,all the stacks. (Get that bag), I’m pushin p gonna keep it real, No Nas but my flow is steel.

Explanation:

Why do you think it is important to invert the bottle and the syringe before filling the syringe

Answers

Answer:

so that there are no possible air bubbles or harmful problems

Explanation:

What do you call the space
where a chondrocyte sits in?
Select one:
O a. Space of Disse
O b. Space of Mall
O c. Vacuole
O d. Lacuna​

Answers

Answer:

the space where a chondrocyte sits in is Lacuna.

If a drug contains 50 milligrams/5 milliliters of medication, how many milligrams are contained in 1 tablespoon of medication?

Answers

Answer:

150 milligrams

Explanation:

1 U.S tbsp contains roughly 15 milliliters.

So 5x3 = 15 milliliters 50x3=150 milligrams.

?

Approximately 147.9 milligrams are contained in 1 tablespoon of medication.

To determine the number of milligrams in 1 tablespoon of medication, we need to know the conversion factor between milliliters and tablespoons. Typically, 1 tablespoon is equal to approximately 14.79 milliliters.

Given that the drug concentration is 50 milligrams/5 milliliters, we can set up a proportion to find the amount in 1 tablespoon:

(50 milligrams / 5 milliliters) = (x milligrams / 14.79 milliliters)

Cross-multiplying and solving for x, we get:

x = (50 milligrams / 5 milliliters) * 14.79 milliliters

x ≈ 147.9 milligrams

Therefore, approximately 147.9 milligrams are contained in 1 tablespoon of medication.

Learn more about drug concentrations, here:

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Any medical professionals that can help diagnose this for me please?

I got a lab test back that says I have high CK, low vitamin D, low ferratin, low PTH intact. In pain a lot on and off, it started in June only in the chest, but now is constant in the feet, toes, hands, legs. It feels like nerve damage honestly I’ve considered MS, fibromyalgia, etc. Doctors haven’t been helpful in figuring out what it is and dismiss it as in my head or anxiety related. Let me know if you need more info but I’d really like any thoughts from anyone in the medical community or familiar with any of these symptoms altogether!

Answers

Answer:

Use Amberen for about a week if you start feeling unwanted side effects stop using it and call you doctor amediantly... Hope this helps^_^ plz leave Brainliest and rating.

1. Key unit of contraction composed of bundled parallel protein myofilaments

2. This part of muscle cell transmits AP.

Answers

Answer:

i am not sure but i think you talk about myosin it is bind with ATP to do the contraction with actin

Could someone help with 67? Please no links

Answers

Answer:

1. Facies anterior is the answer

The answer is 1!!
Hope this helps!

Pharmacy Polices and Procedures

Identifying the Technician's Responsibilities

In the Look-Alike and Sound-Alike Drugs Policy, what is the pharmacy technician responsible for doing? Select all that apply.

a. performing annual reviews of quality-control issues
b. being aware of possible look-alike drugs
c. reading labels printed with tall man lettering
d. storing drugs in proper storage locations
e. notifying pharmacy staff of the policy

Answers

Answer:

B. Being aware of possible look-alike, sound-alike drugs

C. Reading labels printed with tall man lettering

D. String drugs in proper storage locations

Explanation:

I calculated it logically

Dentinal Sclerosis occurs frequently in active carious lesions. TRUE OR FALSE.

Answers

Answer:a

Explanation:

List the three main European caves that were talked about in the lecture. List them in order from the cave that contains the oldest cave art to the most recently created cave art?

Answers

The correct answer to this open question is the following.

Unfortunately, you did not include the lecture, so we do not know what was the information included in the lecture. Just you know it.

However, trying to help you, we can answer based on our knowledge of this topic.

These are the three main European caves.

1.- Altamira cave in Spain. More than 35,000 years old.

2.- Lascaux paintings in France. More than 17 years old.

3.- Magura cave in Bulgaria. More than 10 years old.

These caves are impressive historical references that have been researched by experts to understand what could have been the meaning our ancestors tried to express with their paintings. Of course, there are many interpretations and controversies around the interpretation of what is described. However, it is our responsibility to take care of these important paintings that give us an idea of what was the vision of the reality of those primitive humans.

A middle school took all of its 6th grade students on a field trip to see a ballet at a theater that has 4700 seats. The students left 12% of the seats in the theater vacant. How many 6th graders went on the trip?

Answers

Find 12% of 4700
4700 * 0.12 = 564 (vacant seats)
4700 - 564 = 4136

Solution: 4136 students

bones that surround the spinal cord are classified as_______ bones

Answers

Answer:

Irregular Bones

Explanation:

"These bones tend to have more complex shapes, like the vertebrae that support the spinal cord and protect it from compressive forces. Many facial bones, particularly the ones containing sinuses, are classified as irregular bones." - https://vivaopen.oercommons.org

Bones that surround the spinal cord are classified as Irregular bones.

Thus, These bones frequently have more intricate forms, such as the vertebrae that support and shield the spinal cord from compression stresses. Numerous facial bones are categorized as irregular bones, especially those that contain sinuses.

Vertebrae are the bones that the spinal cord is protected by. The vertebral column, often known as the spine or backbone, is made up of a number of separate bones called vertebrae.

The spinal cord goes through the central canal created by the vertebrae and is protected and flexible by the vertebral column.

Thus, Bones that surround the spinal cord are classified as Irregular bones.

Learn more about Bones, refer to the link:

https://brainly.com/question/33453816

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Who is the Founder of Modern Nursing

Answers

Florence Nightingale, the founder of modern nursing, was born in 1820 to a wealthy British family. Determined to help the sick, Nightingale cared for the poor and infirm in the village surrounding her family's estate. She later enrolled in a nursing school in Germany, much to the consternation of her parents.

Hope this helps you!!
Florence Nightingale is revered as the founder of modern nursing

28. Which of the following is NOT why we pay federal income tax? *
publish newspapers
required by law
required by the U.S. Constitution in the 16th Amendment
all people pay to fund the federal government

Answers

Answer:

D, all people pay to fund the federal government.

Explanation:

The money you pay in taxes is used in a variety of ways. Your tax dollars fund common services such as police and firefighters, in addition to funding the wages of government employees. Tax dollars pay to keep the highways you use clean and well-maintained.

Which of the following is true of friendships in middle adulthood?

Answers

Answer: I  don't have the other answer choices but i would say it is something to deal abut kids

Explanation:

Please help and no links as answers, thank you!

Answers

Answer:

I think A

Explanation:

Spina illiaca anterioe inferior

Which of the following are believed to be causes of pain in an inflamed area
Select one:

a. Pressure of the exudate

b. Changes in the pH caused by acidic breakdown products
c. Release of chemical mediators that stimulate nerve endings
d. A and C​

Answers

it’s C release of chemical mediators that stimulate nerve endings

Discuss thoroughly how a printer works.

Answers

Explanation:

In short, printers work by converting digital images and text into physical copies. They do this using a driver or specialised software that has been designed to convert the file into a language that the printer can understand. The image or text is then recreated on to the page using a series of miniscule dots.

you connect your laptop to the printer either with Bluetooth or plug and you press the print button and then the printer reads the paper you want to print and then scanned ink onto the paper and then immediately drive and then you have to complete printed sheet

Osteoporosis is a bone disease caused by loss of bone density. What type of bone
tissue would be affected by osteoporosis?
A. Just spongy bone
B. Just compact bone
C. Mostly the spongy and also the compact
D. Mostly the compact bone and never the spongy bone

Answers

C. Mostly the spongy and also the compact

what are hallucinations?​

Answers

Answer:

Hallucination can have causes that aren't because of fundamental illness. Models incorporate medication inebriation.

Explanation:

It’s a mental illness where a person say they see things that are not possible

Scenario One Ethan walks through his house and steps his left foot on a game piece lying on the floor. The game piece is sharp. He quickly lifts his foot and shouts, "Ouch!" Ethan grabs the bottom of his foot with both hands and hops up and down on his right foot. Input the PNS receives Output the CNS sends out CA​

Answers

Answer:

PNS receives information from sensory neurons whereas  the CNS sends out to the muscles through motor neurons.

Explanation:

The Peripheral nervous system receives the message from sensory neurons that are present on the foot. After that, Peripheral nervous system sends this sensory information about the body to the central nervous system such as brain and spinal cord. After receiving information from Peripheral nervous system, the central nervous system order the muscles of the leg to lift his leg far away from the sharp game piece. The orders taken by the motor neurons which is responsible for carrying instructions from central nervous system to the muscles for action against stimulus.

Automated hematology procedures have many advantages over manual methods list five of these advantages

Answers

Answer:

What are the celluar components of blood? erythrocytes ... Hemoglobin..serves to transport oxygen and carbon dioxide through the body. Upgrade ... Which cell type is most numerous? ... What is the difference between Wintrobe method and Westergen method? ... List five advantages of Automated hematology procedures.

Explanation:

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