Fundamentals of GCP and Clinical Research

Fundamentals of GCP and Clinical Research

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.

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