A Clinical Trials Manual from the Duke Clinical Research by Margaret B. Liu, Kate Davis(auth.)

By Margaret B. Liu, Kate Davis(auth.)

Content material:
Chapter 1 classes from a Horse Named Jim and different occasions in heritage Affecting the legislation of medical examine (pages 1–11):
Chapter 2 the method: constructing New medicinal drugs, Biologics, and units (pages 13–48):
Chapter three solid medical perform and the laws (pages 49–72):
Chapter four proficient Consent and the laws (pages 73–100):
Chapter five Institutional overview forums (pages 101–121):
Chapter 6 hostile occasions and Unanticipated difficulties related to hazards to matters or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The vital Investigator, the scientific learn Coordinator, and the learn website (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 records (pages 245–269):
Chapter thirteen administration of research medicinal drugs, Biologics, and units (pages 271–279):
Chapter 14 coping with scientific Trial facts (pages 281–311):
Chapter 15 worldwide wellbeing and fitness 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

Sample text

Research into embryonic stem cells seeks to identify precise approaches that would allow scientists to direct stem cell differentiation into specific tissue types, creating a source of tissue for transplantation to replace damaged tissues. Conditions such as Parkinson’s disease (see box below), spinal cord injury, muscular dystrophy, heart failure, and diabetes could conceivably be treated using these replacement cells. Progenitor cells, also called adult stem cells or somatic stem cells, are isolated from specific bodily tissues.

The NSR category was created to avoid delay and expense in situations where the anticipated risks did not justify FDA involvement. 2(b), but must comply with the same IRB, informed consent, and financial disclosure regulations. They differ from significant risk studies in the approval process (sponsors are not required to submit an IDE application to the FDA), record keeping, and reporting requirements. When a sponsor considers a study to be NSR, the sponsor provides the reviewing IRB with an explanation of its rationale and seeks IRB approval for an NSR study of the device.

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. Continued Access Use may be granted when there is a public health need for the device or when preliminary evidence shows that the device is likely to be effective without significant safety concerns.

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