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- Author: Sanjay Gupta
- Publisher: Cr Books Pvt. Ltd.
- Year: 2013
- Pages: 86
- ISBN-10: 8192227723
- ISBN-13: 9788192227726
- Format: 14 x 21.6 x 0.5 cm, minkšti viršeliai
- Language: English
- SAVE -10% with code: EXTRA
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Description
This book is intended to provide a fundamental knowledge on Clinical Research and Good Clinical Practice (GCP) Guidelines with a crisp description on important topics such as Introduction to Clinical Research; Evolution of Ethical Research Principles, Regulations and Guidelines; Essential Clinical Trial Documents; Clinical Study Process; Ethics Review Board (ERB); Roles and Responsibilities of Investigator; Roles and Responsibilities of Sponsor; Informed Consent Process; Serious Adverse Event (SAE), Maintenance of Source Document, IND/NDA/ANDA/AADA and List/Location of Essential Trial Documents Before, During and After Completion/Termination of the Trial.
EXTRA 10 % discount with code: EXTRA
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- Author: Sanjay Gupta
- Publisher: Cr Books Pvt. Ltd.
- Year: 2013
- Pages: 86
- ISBN-10: 8192227723
- ISBN-13: 9788192227726
- Format: 14 x 21.6 x 0.5 cm, minkšti viršeliai
- Language: English English
This book is intended to provide a fundamental knowledge on Clinical Research and Good Clinical Practice (GCP) Guidelines with a crisp description on important topics such as Introduction to Clinical Research; Evolution of Ethical Research Principles, Regulations and Guidelines; Essential Clinical Trial Documents; Clinical Study Process; Ethics Review Board (ERB); Roles and Responsibilities of Investigator; Roles and Responsibilities of Sponsor; Informed Consent Process; Serious Adverse Event (SAE), Maintenance of Source Document, IND/NDA/ANDA/AADA and List/Location of Essential Trial Documents Before, During and After Completion/Termination of the Trial.
Reviews