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...

Full description

Saved in:
Bibliographic Details
Main Authors Cingi, Cemal (Author), Bayar Muluk, Nuray (Author)
Corporate Author SpringerLink (Online service)
Format Electronic eBook
LanguageEnglish
Published Cham : Springer International Publishing : Imprint: Springer, 2017.
Subjects
Medicine.
Surgery.
Pharmacy.
Medical education.
Statistics.
elektronické knihy
electronic books
Online AccessFull text
ISBN9783319443447
DOI10.1007/978-3-319-44344-7
Physical DescriptionXVIII, 237 p. online resource.

Cover

Table of Contents:
  • 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.

Similar Items