The new regulation permits but does not require inclusion of pregnant women in clinical research

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• Clinical Research Management

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• 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?

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• 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?

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• 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?

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• 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?

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