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| DIPLOMA IN CLINICAL RESEARCH Syllabus of Diploma in Clinical Research1. INTRODUCTION TO CLINICAL RESEARCH Definition, Types and Scope of Clinical Research, Good Clinical Practices Drug Development Process Careers in Clinical Research 2. ETHICS IN CLINICAL RESEARCH Ethical Theories and Foundations, Ethics Review Committee and Informed Consent Process, Integrity & Misconduct in Clinical Research Conflicts of Interest 3. REGULATIONS IN CLINICAL RESEARCH Evolution and History of Regulations in Clinical Research, Patents US Regulatory Structure, IND, NDA, ANDA, Post Drug Approval Activities, PMS, FDA Audits and Inspections EURegulatory Affairs, EMEA Organization and Function, INDIAN Regulatory system, Schedule Y- Rules and Regulations 4. CLINICAL RESEARCH METHODOLOGY Designing of Protocol, CRF, e-CRF, IB, ICF, SOP Pharmaco-epidemiology, BA/BE Studies Report writing, Publication 5. CLINICAL RESEARCH MANAGEMENT Preparation of a successful clinical study, Study management, Project management Documentation, Monitoring, Audits and Inspections Pharmacovigilance Training in clinical research Budgeting in clinical research, Supplies and vendor management 6. BIOSTATISTICS AND DATA MANAGEMENT Importance of statistics in clinical research Statistical considerations at the design, analysis and reporting stage. Data management, Data validation, SAE reconciliation, query management Software considerations Eligibility Graduates in Life Sciences, Pharmacy and Medicine with 55% aggregate marks. The Diploma Program is available in two modes 1. Campus Based Classes are held on weekends (Saturday/Sunday). The curriculum is covered in course attendance of 8hrs X 28 days. 2. E-Learning Click here to go to e-learning
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