A Guide for Clinical Research Professionals

A Guide for Clinical Research ProfessionalsA 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

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 and other issues.