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Fundamentals of Gcp and Clinical Research Mr. Sanjay Gupta 1st edition
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Fundamentals of Gcp and Clinical Research
Mr. Sanjay Gupta
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.
| Media | Books Paperback Book (Book with soft cover and glued back) |
| Released | August 15, 2013 |
| ISBN13 | 9788192227726 |
| Publishers | CR Books Pvt. Ltd. |
| Pages | 86 |
| Dimensions | 138 × 5 × 213 mm · 108 g |
| Language | English |
