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Quick guide to good clinical practice : how to meet international quality standard in clinical research

https://bccalibrary.andornot.com/en/permalink/catalog120841
Cingi, Cemal, Muluk, Nuray Bayar. Cham, Switzerland: Springer , 2016.
Audience
Professional
Table of Contents:; Chapter 1: Clinical Trials: Historical Aspects and Importance and New Drug Developments -- Chapter 2: The Definition of GCP -- Chapter 3: The Principles of GCP -- Chapter 4: The Drug Development Process and Evolution of Regulations -- Chapter 5: Planning Clinical Research -- Cha…
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Alternate Title
How to meet international quality standard in clinical research
Author
Cingi, Cemal
Muluk, Nuray Bayar
Place of Publication
Cham, Switzerland
Publisher
Springer
Publication Date
2016
Series
EBSCOhost eBook
Subjects
Clinical Trials as Topic
Biomedical Research
Ethics, Research
Data Accuracy
Total Quality Management - standards
Internationality
Practice Guideline
Abstract
Table of Contents:
Chapter 1: Clinical Trials: Historical Aspects and Importance and New Drug Developments -- Chapter 2: The Definition of GCP -- Chapter 3: The Principles of GCP -- Chapter 4: The Drug Development Process and Evolution of Regulations -- Chapter 5: Planning Clinical Research -- Chapter 6: Preparation of Ethics Committee (IRB) Proposal -- Chapter 7: Preparation of Informed Consent -- Chapter 8: Preparation of Findings Tables -- Chapter 9: Setting the Ideal Statistical Methods -- Chapter 10: The Duties of a Clinical Research Coordinator
-- Chapter 11: The Duties of Clinical Researchers -- Chapter 12: The Phases of Clinical Studies -- Chapter 13: Safety in Clinical Trials -- Chapter 14: Setting the Size -- Chapter 15: Setting the Ideal Method -- Chapter 16: Ethics of Clinical Research -- Chapter 17: Recruitment and Enrolment -- Chapter 18: Why We Need Clinical Consent and Other Documentation -- Chapter 19: Monitoring the Trial -- Chapter 20: Inspection -- Chapter 21: Ethics: Institutional Review Board/Independent Ethics Committee (IRB/IEC) -- Chapter 22: Responsibilities of the Investigator -- Chapter 23: Responsibilities of the Sponsor -- Chapter 24: Clinical Trial Protocols
ISBN
9783319443430
9783319443447
Language
English
Material Type
Ebook
Audience
Professional
Location
Internet
Website Notes
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