Quick guide to good clinical practice : how to meet international quality standard in clinical research /
|Author / Creator:||Cingi, Cemal.|
|Imprint:||Cham, Switzerland : Springer, , ©2017.|
|Description:||1 online resource|
Total Quality Management -- standards.
HEALTH & FITNESS -- Holism.
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MEDICAL -- Alternative Medicine.
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MEDICAL -- Family & General Practice.
MEDICAL -- Holistic Medicine.
MEDICAL -- Osteopathy.
|URL for this record:||http://pi.lib.uchicago.edu/1001/cat/bib/11268981|
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.