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Titlebook: Developing a Successful Clinical Research Program; Cara East Book 2018 Springer International Publishing AG, part of Springer Nature 2018

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Maintaining Subject Retention and Avoiding Study Fatigue,t all. There are multiple methods to impute missing data, but none are as good as having retained the subject in follow-up. The site can use many methods to maintain subject retention, including providing a stipend for visits, providing transportation or travel assistance, and having great staff. Ha
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Adverse Events and Protocol Deviations,involved in a research procedure. A serious adverse event is one that results in death, is life-threatening, requires hospitalization, results in a persistent or significant disability or incapacity, and results in a congenital anomaly or birth defect, or other serious conditions, such as a new canc
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Contract Research Organizations and Monitors,hat serve the various research needs of pharmaceutical sponsors. The pharmaceutical industry invests as much as five times as much as the average manufacturing company does in research and development. CROs allow the industry to outsource many of the steps of the clinical research process. The CRO i
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Evaluating Cabinet Decision-Makingve device, or sham procedure is being used. Processes are lengthy, and the best staff are those who are good at different tasks. Start-up procedures include executing a clinical disclosure agreement (CDA), negotiating a contract, developing a budget, and writing a good consent.
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https://doi.org/10.1057/978-1-349-95109-3participating in the trial. More time should be spent on the consent process that on almost any other procedure in the trial. “If you take a medicine, thank a research subject.” A great consent most successfully makes the subject into a research partner.
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