By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in historical past Affecting the law of medical learn (pages 1–11):
Chapter 2 the method: constructing New medicines, Biologics, and units (pages 13–48):
Chapter three sturdy medical perform and the rules (pages 49–72):
Chapter four educated Consent and the laws (pages 73–100):
Chapter five Institutional evaluation forums (pages 101–121):
Chapter 6 antagonistic occasions and Unanticipated difficulties concerning hazards to topics or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The important Investigator, the scientific study Coordinator, and the examine web site (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 learn Feasibility: Reviewing a selected Protocol (pages 199–212):
Chapter eleven research actions (pages 213–244):
Chapter 12 research Documents/Essential records (pages 245–269):
Chapter thirteen administration of analysis medicines, Biologics, and units (pages 271–279):
Chapter 14 dealing with medical Trial facts (pages 281–311):
Chapter 15 worldwide health and wellbeing and overseas 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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Extra resources for A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition
The chart below includes examples of nonsignificant risk and significant risk devices. gov/cdrh). Similar to investigational drugs and biologics, some devices require FDA authorization in order to conduct clinical trials before the FDA provides marketing approval. Unlike drugs that fall into only one regulatory category, a device is subject to different regulations, depending on which of the three categories (Premarket Notification, Premarket Approval, IDE-Exempt) applies. Substantially Equivalent Devices When determining the necessary regulatory requirements to market a device, the sponsor should refer to the devices listed in the Specialty Panels in 21 CFR 862 to 892.
Developing Drugs, Biologics, and Devices Requirements for Marketing New Devices Substantial equivalence means that when compared to the pre-amendment device, the new device: n has the same intended use and the same technological characteristics, or n has different technological characteristics that do not raise new safety and effectiveness questions, assuming the sponsor demonstrates that the new device is as safe and effective as the predicate device. Devices that Require Premarket Notification [510(k)] When the FDA determines that a device is substantially equivalent to a pre-amendment device, Class I, Class II, and some Class III devices can be marketed using the premarket notification [510(k)] process.
Recognizing these limitations, Congress passed the 1938 Food, Drug & Cosmetic Act, which required premarket approval of new drugs, giving the newly-formed FDA authority to review drug safety before marketing. In 1962, in response to the scope of the thalidomide tragedy, Congress passed the Kefauver-Harris Amendment to the Food, Drug & Cosmetic Act requiring proof of drug effectiveness and greater proof of safety before marketing. qxd 15:17 Page 15 New Drug Development Timeline 2. 1 11/16/09 Pre-Clinical Studies When new compounds show potential in laboratory tests, studies are designed to evaluate these compounds for pharmacologic use.