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1. COMPUTER ARCHITECTURE & ORGANIZATION: Combinational ...

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5) Clinical Research Methodology: Epidemiological Studies, Clinical Trial Design,Phases of Clinical Research, Aim of different Phases, Intellectual PropertyRights (TRIPS and GATT ), Indian Patent Law, Endpoints in Clinical Trials,Quality of Life Studies, Pharmacoeconomic studiesReference Books: Guide to Clinical Trials by Bert Spilker, Lippincott Williamsand WilkinsBasic Principles of Clinical research and Methodology by S.K Gupta6) Bioethics : Background of ethics in Clinical Research, Ethical Principles, EthicsCommittees- Roles and Responsibilities, Privacy and Confidentiality,Importance of Informed Consent Form in Clinical Research, use of placeboReference Books: Protecting Study Volunteers in research by C.M Dunn,Thomson Centre watch , Boston7) Clinical Trial Management : Basics of Project Management, Steps involved inProject Development , Managing the project Team, Tracking Management ofProject, Clinical Research Outsourcing , Offshoring, Monitoring of ClinicalTrials, Audits and InspectionReference Books: Project Management by Gray, Larson, DesaiThe CRA’s guide to Monitoring Clinical Research by Karen E. Woodin and JohnC. SchneiderBasic Principles of Clinical research and Methodology by S.K Gupta******************************************************

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