Description
– 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.
