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.
- 113 pages
- English
- PDF
- Available on iOS & Android
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Table of contents
- Cover
- Contents
- 1: International Standards Related to Clinical Research
- 2: Clinical Research and Ethics Committees
- 3: Clinical Study Design
- 4: The Study Monitorand the Routine Visit
- 5: Clinical Study Protocol
- 6: Case Report Formand Its Completion
- 7: Investigator Study File
- 8: Documentation and Archiving
- 9: Study Initiation
- 10: Delegation of Duties
- 11: Subject Information and Consent
- 12: Subject Recruitment
- 13: Randomisation and Blinding
- 14: Investigational Product
- 15: Safety in Clinical Studies
- 16: Audit and Inspections
- 17: Study Closure
- 18: Clinical Study Report and Publication
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Yes, you can access Guide for Clinical Trial Staff by G. Fortwengel in PDF and/or ePUB format, as well as other popular books in Medicine & Communication Studies. We have over one million books available in our catalogue for you to explore.