Guide for Clinical Trial Staff
eBook - PDF

Guide for Clinical Trial Staff

Implementing Good Clinical Practice.

  1. English
  2. PDF
  3. Available on iOS & Android
eBook - PDF

Guide for Clinical Trial Staff

Implementing Good Clinical Practice.

Book details
Table of contents
Citations

About This Book

The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.

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Yes, you can access Guide for Clinical Trial Staff by Fortwengel in PDF and/or ePUB format, as well as other popular books in Medicine & Family Medicine & General Practice. We have over one million books available in our catalogue for you to explore.

Information

Publisher
S. Karger
Year
2003
ISBN
9783318010312
Edition
1
Topic
Medicine
Subtopic
Family Medicine & General Practice

Table of contents

  1. Cover
  2. Contents
  3. 1: International Standards Related to Clinical Research
  4. 2: Clinical Research and Ethics Committees
  5. 3: Clinical Study Design
  6. 4: The Study Monitorand the Routine Visit
  7. 5: Clinical Study Protocol
  8. 6: Case Report Formand Its Completion
  9. 7: Investigator Study File
  10. 8: Documentation and Archiving
  11. 9: Study Initiation
  12. 10: Delegation of Duties
  13. 11: Subject Information and Consent
  14. 12: Subject Recruitment
  15. 13: Randomisation and Blinding
  16. 14: Investigational Product
  17. 15: Safety in Clinical Studies
  18. 16: Audit and Inspections
  19. 17: Study Closure
  20. 18: Clinical Study Report and Publication