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Fundamentals of GCP and Clinical Research

Bag om Fundamentals of GCP and Clinical Research

This book is intended to provide a fundamental knowledge on Clinical Research and Good Clinical Practice (GCP) Guidelines with a crisp description on important topics such as Introduction to Clinical Research; Evolution of Ethical Research Principles, Regulations and Guidelines; Essential Clinical Trial Documents; Clinical Study Process; Ethics Review Board (ERB); Roles and Responsibilities of Investigator; Roles and Responsibilities of Sponsor; Informed Consent Process; Serious Adverse Event (SAE), Maintenance of Source Document, IND/NDA/ANDA/AADA and List/Location of Essential Trial Documents Before, During and After Completion/Termination of the Trial.

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  • Sprog:
  • Engelsk
  • ISBN:
  • 9788192227726
  • Indbinding:
  • Paperback
  • Sideantal:
  • 86
  • Udgivet:
  • 15. august 2013
  • Størrelse:
  • 140x216x5 mm.
  • Vægt:
  • 109 g.
  • 2-3 uger.
  • 26. november 2024
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This book is intended to provide a fundamental knowledge on Clinical Research and Good Clinical Practice (GCP) Guidelines with a crisp description on important topics such as Introduction to Clinical Research; Evolution of Ethical Research Principles, Regulations and Guidelines; Essential Clinical Trial Documents; Clinical Study Process; Ethics Review Board (ERB); Roles and Responsibilities of Investigator; Roles and Responsibilities of Sponsor; Informed Consent Process; Serious Adverse Event (SAE), Maintenance of Source Document, IND/NDA/ANDA/AADA and List/Location of Essential Trial Documents Before, During and After Completion/Termination of the Trial.

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