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About the Book:

·       Comprehensive content covering all aspects of clinical research.

·       Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc.

·       Milestones in the evolution of drug regulations in India

·       Drug regulatory framework in India and key ICH countries.

·       Evolution of drug pricing mechanisms and IPRs in India.

·       Updated text incorporating the New Drugs and Clinical Trials Rules 2019; Guidelines on BA/BE studies; ICMR National Ethical Guidelines 2017; National Guidelines for Stem Cell Research 2017; Medical Devices Rules 2017.

·       Latest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019.

·       Templates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc.