An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk.
A. There was no need to inform the IRB because this was a screening procedure.
B. This is an adverse event, which is also an unanticipated problem.
C. This is an unanticipated problem requiring notification to the IRB and FDA.
D. This is neither an unanticipated problem, nor an adverse event.

Answer:

The correct answer is - C.

Explanation:

Unanticipated problems can be explained as any incident or outcome that follows the following:

Unexpected result or incident in terms of nature, severity, or frequency, stander process and subject being studied. If the incident or problem may or definitely going to affect rights, safety or wellness. If there is any type of risk physiological, economical social harm.

Investigators must report all unanticipated problems and events to the IRB if it meets the criteria given above.

Thus, the correct answer is - C.

Compression of the heart caused by the accumulation of blood or other fluid within the pericardial sac, thus preventing the ventricles from adequately filling or pumping blood, is known as cardiac tamponade. True or False

Which is the best treatment for a severe bleeding injury?

Natural disasters are always more harmful than man-made disasters. t or d

Explain how a disease of the connective tissue could affect the structure and function of the following body systems: a) integumentary
b) skeletal
and
c) muscular.

Researchers communicate their aims as problem statements, statements of purpose, research questions, or hypotheses. What does the following statement represent, "Nausea and vomiting are common side effects among patients on chemotherapy, and interventions to date have been only moderately successful in reducing these effects? New interventions that can reduce or prevent these side effects need to be identified."
A) Hypothesis
B) Problem statement
C) Statement of purpose
D) Research question

How might your current dating behaviors affect your short-term health? Long-term health? (2 points)

Your environment can affect your health. Now that you have made a personal wellness plan, consider how you can make your environment "well."

muscle tissue is strained because it contains

2. De los fundamentos técnicos del baloncesto cual nos sirve para comunicarnos con un compañero A. El dribling B. El pase C. El tiro D. Todas las anteriores

AIDS can be cured with the appropriate drugs

Name three things doctor can do if your kidneys don,t work.​

Which of the following statements about obstetrics was true in the 18th century? Medical doctors became midwives. In many medical schools it was considered improper for a man to see a woman's genitals under any circumstances. Obstetric doctors were considered to be witches. Medical students learned about assisting a birth by helping with 25 childbirths.

To ensure your score in a fitness evaluation is properly recorded, the proctor must count your repetitions.

A 10-year-old child is admitted to the hospital for surgery. The parents state that the child is mentally challenged and functions on the level of a 3-year-old. What should be included in the child's preoperative teaching plan

where is mount everest​

What is the correct order of events in an effective negotiation session?

A. Brainstorm solutions.
B. Define the issue.
C. Choose the best solution.
D. Discuss your feelings.

Which steps can you take to help a person suffering from alcohol abuse? Select three options.
Call a treatment service.
Post updates of the abuse on your social media page.
Confide in someone you trust.
Seek out a healthcare professional.
Report the problem to the local authorities.

How is cardio exercise best described?

Rosita wants to have healthy peer relationships. Which action would best help Rosita achieve this goal?

treating other people the way she thinks they deserve to be treated
treating other people the way she wants to be treated
expecting other people to treat her the way she deserves to be treated
treating other people the way she feels like treating them in any given moment

Jocelyn has a part-time job, and the hours vary week to week. She also has basketball practice four times a week and monthly club meetings. Lately, she has felt stressed, and it is interfering with her ability to sleep well. Which of the following could most effectively help Jocelyn manage her stress? (5 points) Select one: a. She could call in sick to work, skip basketball practice to catch up on her sleep, and then go mountain biking. b. She could talk to her boss about the demands of juggling a job, school, and extracurricular activities. c. She could use a planner to organize her schedule and build in short nature walks on the weekends. d. She could quit her job, drop out of clubs, and take up horseback riding to get away from everything.

Name the sound producing organ in humans.​

Define Prejudice and Discrimination, discuss why they exist and possible solutions for eliminating or at least reducing acts of discrimination.

The health commissioner said that the government had implemented strict measures to eradicate the contaminated food and, despite the recent illnesses, it will try to prevent the outbreak from recurring in the future.
(A) it will try
(B) that it tried
(C) it had tried
(D) it would have tried
(E) that it would try

The intensity of your workout is too difficult if your heart rate has not returned to 120 bpm within how many minutes? Select one: a. 5 minutes b. 10 minutes c. 12 minutes d. 15 minutes

4. why basic need is better to measure the quality of life
​

Which of the following indicates a skill that must be mastered, or an ability that must be cultivated for normal and optimal development?
Self-awareness
A developmental task
A social smile

The food guide pyramid is a guideline created by the US Department of agriculture to encourage Americans to make healthy choices and to eat a balanced diet how does the food pyramid accomplish these goals do you think the food guide pyramid is effective why or why not

One friend is stressing out over life and is over-eating to deal with all of the stress. The other friend says "You are so grossing me out, aren't you worried you will get fat!"

health education helps to be free from fatal diseases​

The nursing instructor is conducting a session with a group of nursing students exploring potential difficulties of newborns involving respiratory concerns. The instructor determines the session is successful after the students correctly choose which contributing factor for transient tachypnea of the newborn?