Clinical Research

Angebote / Angebote:

· 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.

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