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Clinical
Research Management
1. Explain the steps involved in “Designing
Clinical Trials?”
2. Explain in detail Responsibilities of
CRC(Clinical Research Coordinator) and
CRA(Clinical Research Associate)?
3. Explain in your words the “Ethical
issues in patient recruitment”?
4. Explain in detail different types of
audits involved in Clinical Trials?
1.
How
can Dr. Brown or Dr. Jones find an appropriate clinical trial for Mr. Smith?
2.
What arguments can be put forward in favor of
paying people for participating in clinical trials?
3.
How convincing is the view that the market
should decide how much subjects should be paid? That is, should people be
offered as much as is necessary for them to agree to participate, or is there
something about research that makes another standard of payment appropriate?
4.
How convincing is the notion that participation
in clinical trials is like low-skill work and therefore worthy only of a
minimum wage?
5.
The goal of Federal Regulations is to protect
research subjects. Do you believe that the original regulations took an
appropriate approach to protecting fertile females, pregnant women, and fetuses
from research risk? What was the effect of this approach?
6.
The new regulation permits but does not require
inclusion of pregnant women in clinical research. Do you believe that
pharmaceutical manufacturers will be interested in increasing studies in
pregnant women? What are the incentives? What are the obstacles?
7.
Fear of legal liability leads researchers and
sponsors to guard against participation of pregnant women in clinical research.
Do you think that mechanisms to address this fear would work to increase the
role of women in clinical studies? Such mechanisms include, for example, caps
on the liability sponsors would face, creation of a federal fund to compensate
harmed subjects, and building liability costs into the costs of doing business.
Should one or more of these mechanisms be put in place to increase involvement
of pregnant women in clinical trials?
WE PROVIDE CASE STUDY ANSWERS, ASSIGNMENT SOLUTIONS, PROJECT REPORTS AND THESIS
ARAVIND - 09901366442 –
09902787224
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