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Clinical Research: Principles, Practice and Perspective
Hardcover
ISBN13: 9789389974447
Publisher: Pharmamed Press
Published: Apr 1 2023
Pages: 508
Weight: 2.38
Height: 1.13 Width: 7.50 Depth: 9.25
Language: English
- 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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