The goal of Federal Regulations is to protect research subjects - PowerPoint PPT Presentation

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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?

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?

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?

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?