Quick Guide to Good Clinical Practice How to Meet International Quality Standard in Clinical Research /

• Κύριοι συγγραφείς: Cingi, Cemal (Συγγραφέας), Bayar Muluk, Nuray (Συγγραφέας)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2017.
• Θέματα: Medicine.; Surgery.; Pharmacy.; Medical education.; Statistics.; Medicine & Public Health.; Drug Safety and Pharmacovigilance.; Statistics for Life Sciences, Medicine, Health Sciences.; General Surgery.; Medical Education.

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...

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.