Quick Guide to Good Clinical Practice How to Meet International Quality Standard in Clinical Research /
This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective o...
Κύριοι συγγραφείς: | , |
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Συγγραφή απο Οργανισμό/Αρχή: | |
Μορφή: | Ηλεκτρονική πηγή Ηλ. βιβλίο |
Γλώσσα: | English |
Έκδοση: |
Cham :
Springer International Publishing : Imprint: Springer,
2017.
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Θέματα: | |
Διαθέσιμο Online: | Full Text via HEAL-Link |
Πίνακας περιεχομένων:
- 1 Clinical Trials: Historical Aspects and Importance and New Drug Developments
- 2 The Definition of GCP
- 3 The Principles of GCP
- 4 The Drug Development Process and Evolution of Regulations
- 5 Planning Clinical Research
- 6 Preparation of Ethics Committee (IRB) Proposal
- 7 Preparation of Informed Consent
- 8 Preparation of Findings Tables
- 9 Setting the Ideal Statistical Methods
- 10 The Duties of a Clinical Research Coordinator
- 11 The Duties of Clinical Researchers
- 12 The Phases of Clinical Studies
- 13 Safety in Clinical Trials
- 14 Setting the Size
- 15 Setting the Ideal Method
- 16 Ethics of Clinical Research
- 17 Recruitment and Enrolment
- 18 Why we need Clinical Consent and Other Documentation
- 19 Monitoring the Trial
- 20 Inspection
- 21 Ethics - Institutional Review Board/Independent Ethics Committee(IRB/IEC)
- 22 Responsibilities of the Investigator
- 23 Responsibilities of the Sponsor
- 24.Clinical Trial Protocols.