Titlebook: Conducting Clinical Trials; Frank L. Iber,W. Anthony Riley,Patricia J. Murray Book 1987 Plenum Publishing Corporation 1987 clinical resear

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Data Item Quality for Biobanks,panies spend up to $100 million to develop an effective new drug that actually reaches the market (see page 4). To bring a generic drug onto the market costs up to $3 million. Only a minor fraction of these costs are expended on the actual clinical trials because extensive animal testing, regulatory

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https://doi.org/10.1007/978-3-662-66111-6hone contacts and completing CRFs, must be delegated to free the PI to concentrate on the medical aspects of the study. As was discussed in the previous chapter, each new protocol must be analyzed along the lines of budget planning to identify just what duties can be delegated. Table 7 contains a li

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Abdelkader Hameurlain,A Min Tjoa and the IRB. The sponsor ordinarily coordinates all communication with the FDA, such as the filing of the IND itself, submission of the investigator’s credentials to the IND, and reporting of adverse experiences while the study is under way. There may be other local regulatory committees or agencie

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https://doi.org/10.1007/978-3-662-66863-4earch subjects. These review committees must have at least five members of varying backgrounds who can provide the breadth of scientific expertise and sense of community values required to evaluate protocols in many subspecialties of medicine and social science. Their membership ordinarily includes

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https://doi.org/10.1007/978-3-662-68100-8rocess by which the patient and research staff come to a common understanding about what the uncertainties might be. The informed consent process is not a formality or an empty gesture designed to satisfy risk and liability management. It is an interaction—a dialogue intended not only to satisfy the

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Hiba Abou Jamra,Marinette Savonnetion temporarily does not permit them to do so (e.g., unconscious patients). Other patients such as children, prisoners, or the mentally infirm may be less able to give their informed consent because they are especially vulnerable to coercion or misinformation. This chapter is concerned with some iss

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