By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in historical past Affecting the rules of scientific study (pages 1–11):
Chapter 2 the method: constructing New medicinal drugs, Biologics, and units (pages 13–48):
Chapter three reliable medical perform and the laws (pages 49–72):
Chapter four knowledgeable Consent and the rules (pages 73–100):
Chapter five Institutional evaluate forums (pages 101–121):
Chapter 6 hostile occasions and Unanticipated difficulties regarding dangers to topics or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The relevant Investigator, the medical examine Coordinator, and the research web site (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 learn Feasibility: Reviewing a particular Protocol (pages 199–212):
Chapter eleven research actions (pages 213–244):
Chapter 12 examine Documents/Essential files (pages 245–269):
Chapter thirteen administration of research medicinal drugs, Biologics, and units (pages 271–279):
Chapter 14 coping with scientific Trial info (pages 281–311):
Chapter 15 international future health and foreign Trials (pages 313–324):
Read Online or Download A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition PDF
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Additional info for A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition
Each classification panel provides a list of the generic names and an associated 7-digit number for all the devices included in the specialty. Devices are listed with an identification or description of the device, the regulatory class of device (I, II, or III) with or without exemptions or special controls, and the applicable marketing requirements for the device. Device Risk Assessment Based on the assessment of risk to users, devices are either categorized as significant risk devices and subject to clinical investigation under full Investigational Device Exemption (IDE) regulations, or categorized as nonsignificant risk devices and subject to abbreviated IDE regulations.
A device may be exempted from Premarket Notification if it is determined to be “substantially equivalent” to a device that was marketed before the Medical Device Amendments of 1976 or if a Premarket Notification was submitted by another person or sponsor. If the new device is deemed substantially equivalent to a pre-amendment (also called predicate) device, it may be marketed immediately and is regulated in the same regulatory class as the pre-amendment device to which it is equivalent. The device sponsor or manufacturer cannot market the device in the United States until the FDA declares the device to be substantially equivalent.
5 Treatment Use The treatment use provision of the IDE provides desperately ill patients with access to promising new devices before marketing approval has been granted. A treatment IDE application must be submitted to the FDA, after which the FDA has 30 days to respond with notice of approval or disapproval. Treatment use of the device can occur during clinical studies of the device. Continued Access/Extended Investigation Continued enrollment of subjects after the completion of a clinical trial provides access to the medical device during the time when the marketing application is being prepared for submission to the FDA.