Explain the steps involved in “Designing Clinical Trials - PowerPoint PPT Presentation

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Explain the steps involved in “Designing Clinical Trials

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Title: Explain the steps involved in “Designing Clinical Trials


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Clinical Research Management
2
  • Clinical Research Management
  • Q1.Explain the steps involved in Designing
    Clinical Trials?
  • Q2.Explain in detail Responsibilities of
    CRC(Clinical Research Coordinator) and
    CRA(Clinical Research Associate)?
  • Q3.Explain in your words the Ethical issues in
    patient recruitment?
  • Q4.Explain in detail different types of audits
    involved in Clinical Trials?

3
  • Q5.How can Dr. Brown or Dr. Jones find an
    appropriate clinical trial for Mr. Smith?
  • Q6.What arguments can be put forward in favor of
    paying people for participating in clinical
    trials?
  • Q7.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
  • Q8.How convincing is the notion that
    participation in clinical trials is like
    low-skill work and therefore worthy only of a
    minimum wage?
  • Q9.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?
  • Q10.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?

5
  • Q11.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?

6
  • Global Study Solutions
  • Dr. Aravind Banakar
  • aravind.banakar_at_gmail.com
  • www.mbacasestudyanswers.com
  • 9901366442 9902787224
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