Basic Principles of Clinical Research and Methodology

Book Summary of Basic Principles Of Clinical Research And Methodology Table of Contents Clinical Research?Past, Present and Future Drug Development and Discovery Designing Clinical Trials Ethical Issues in Clinical Research ICH-GCP Guidelines Informed Consent Process: Protecting Subjects Rights Role of CRC and CRA in Clinical Trials Protocol Designing Sponsor's and Investigator's Responsibilities Patient Recruitment and Retention in Clinical Trials Project Management in Clinical Trials Pharmacovigilance in Clinical Research Role of Contract Research Organization in Clinical Research Management Outsourcing Clinical Research Biostatistics in Clinical Trials Bioequivalence Studies in Drug Development Finance and Budgeting in Clinical Trials Clinical Data Management Clinical Trials for Herbal Drugs and Traditional Medicines Investigational New Drug Applications Case Report Form Clinical Trial Logs Standard Operating Procedures Audits and Inspections in Clinical Trials Fraud and Misconduct in Clinical Research An Introduction to Medical Writing Communication Skills Requirements and Guidelines to Undertake Clinical Trials in India Schedule Y (Amended Version) APPENDIX I: Data to be Submitted along with the Application to Conduct

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