By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in background Affecting the legislation of medical study (pages 1–11):
Chapter 2 the method: constructing New medications, Biologics, and units (pages 13–48):
Chapter three stable scientific perform and the rules (pages 49–72):
Chapter four knowledgeable Consent and the rules (pages 73–100):
Chapter five Institutional assessment forums (pages 101–121):
Chapter 6 adversarial occasions and Unanticipated difficulties concerning dangers to matters or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The significant Investigator, the medical study Coordinator, and the research web site (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 research Feasibility: Reviewing a selected Protocol (pages 199–212):
Chapter eleven learn actions (pages 213–244):
Chapter 12 research Documents/Essential files (pages 245–269):
Chapter thirteen administration of analysis medications, Biologics, and units (pages 271–279):
Chapter 14 handling scientific Trial information (pages 281–311):
Chapter 15 worldwide health and wellbeing and foreign Trials (pages 313–324):
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Extra info for A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition
16 11/16/09 15:17 Page 17 Once the FDA receives an IND application, the FDA has 30 days to review the application before the sponsor can begin clinical testing. If FDA reviewers identify safety concerns, they will issue a “clinical hold,” a delay or suspension of the proposed investigations identified in the IND. When the FDA issues a hold, the sponsor is notified by telephone, followed by a letter stating the deficiencies. The clinical trial may not be initiated until the issues or concerns that led to a clinical hold are resolved.
2 11/16/09 15:17 Page 30 Device Classes Regulatory Class of Device Regulatory Controls Class I – Common, low-riskdevices General Controls Class II – More complex devices with moderate risk Special Controls Class III – Most complex devices; highest risk Premarket Approval Most are exempt from premarket submission Premarket Notification [510(k)] Includes life sustaining and life supporting devices, devices of substantial importance in preventing health impairment, and devices that present a potentially unreasonable risk of illness or injury Examples • suction snake bite kit • non-sterile examination gloves • band-aids • powered wheelchair • acupuncture needles • surgical drapes • • • • silicone breast implants pacemakers respiratory assist devices heart assist devices potential, unreasonable risk of illness or injury, most are subject to premarket approval.
In such cases, a treatment IND may be issued for the purpose of expanding access to promising new drugs for desperately ill patients who are 24 11/16/09 15:17 Page 25 not participating in the clinical trials. 18 The requirements to issue a treatment IND are: 1) the drug is intended to treat a serious or immediately life-threatening disease; 2) there is no satisfactory alternative treatment; 3) the drug is under investigation or trials have been completed; and 4) the sponsor is actively pursuing market approval.