Klinik Araştırma Profesyonelleri için bir Rehber…

A Guide for Clinical Research Professionals

Paperback, 266 Pages


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A Guide for Clinical Research Professionals covers the following topics: Overview of the Pharmaceutical Industry, Drug Discovery and Drug Development , Pre-clinical studies, New Therapeutic Product – Regulatory Process Overview, Clinical trials – Fundamental elements, Ethical issues in Clinical research, International Conference on Harmonization and Good Clinical Practice, Institutional Review Board / Independent Ethic Committee (IRB/IET): roles and responsibilities, Informed Consent Process, Overview of Some Clinical Trial Essential Documents, Data Collection in Clinical Trials, Investigator: Roles and Responsibilities. Investigator’s Study File, Source Documents & Source Documents Verification (SDV), Clinical Data Validation Process & Query Management, Medical Data Coding & SAE Reconciliation, Statistical issues in clinical trials, Sponsor Definition, Sponsor-Company Responsibilities, Clinical Research Organizations, Clinical Research Associate (CRA)/Clinical Monitor… More >