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Good Clinical Practice

- Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations

af Mindy J Allport-Settle
Good Clinical Practice af Mindy J Allport-Settle
Bag om Good Clinical Practice

Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9780982147672
  • Indbinding:
  • Paperback
  • Sideantal:
  • 712
  • Udgivet:
  • 26. august 2010
  • Størrelse:
  • 152x229x36 mm.
  • Vægt:
  • 934 g.
  • 8-11 hverdage.
  • 6. december 2024
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Beskrivelse af Good Clinical Practice

Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling

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