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Contents 1 Clinical Research A Clinical Investigators Perspective 2 Drug and Device Development Process 3 Preclinical Drug Development 4 Phases of Clinical Trials 5 Phase 0 - Microdosing Stdies 6 Clinical Research Planning 7 Clinical Research Design 8 Clinical Research Protocol 9 Designing Case Report Forms 10 Process of Randomization in Clinical Trials 11 Investigational Medicinal Products 12 Multicenter Clinical Trials 13 Good Clinical Research Practice 14 Role and Responsibilities of Sponsor 15 Role and Responsibilities of Principal Investigator 16 Ethical Consideration in Clinical Research Special Reference to Developing Countries 17 Informed Consent in Clinical Research 18 Monitoring in Clinical Trials 19 Quality Assurance in Clinical Research 20 Pharmacovigilance and Drug Safety 21 Data and Safety Monitoring Board and Monitoring Plan 22 Standard Operating Procedures 23 Archiving Clinical Research Documents 24 Evidence Based Medicine 25 Clinical Research Data Management 26 Clinical BiostatisticsAbout the Book Many health professionals are expected to conduct their own trial or to participate in trials by recruiting subjects Everyone who is conducting clinical research should have a sufficient understanding of the scientific and administrative aspect including an awareness of the regulation and guidelines associated with clinical trials This textbook addresses many issues of human clinical research and clinical trials and provides comprehensive overview of the design conduct and analysis of all the phases of clinical trials It is aimed at health and other research professionals and students Salient Features Book can be used as teaching aid and as a reference guide Important concepts are presented throughout the chapters with diagrams and check lists.
