Post Graduate Certification in Clinical Research

Post Graduate Certification in Clinical Research is offered in collaboration with Institute of Clinical Research, Buckinghamshire, UK. The mode of training is # Regular ( 2 hours-a-day for 5 days in a week) # Part-time ( 3 hours-a-day for 2 days at week-ends) Course Content Overview of Medical Science - Human anatomy, physiology, and biochemistry - Internal Medicine - classification of diseases, basic disease processes, major diseases - Pharmacology & Therapeutics Drug development - Drug design, synthesis, pre-clinical studies, clinical trials Design and Statistical Aspects of Clinical Trials - Phases of clinical trials - Basics of clinical trial design - randomization, blinding, types of design - Basic statistical aspects of clinical trials Good Clinical Practice - Declaration of Helsinki 2000, 2002 and 2004 revision - ICH GCP 1996 - Ethical Guidelines for Biomedical Research in Human Subjects, Central Ethics Committee on Human Research (CECHR), ICMR, 2000 - GCP Guidelines, Central Drugs Standardization and Control Organization, Government of India Clinical Trials - Planning - Sponsor's responsibilities - Essential documentation and Investigator's Brochure - Protocol design - CRF design - Informed Consent Documents - Subject Information Sheet and Informed Consent Form - Investigator selection and agreement Ethics Committee Approvals - Institutional Review Board/Independent Ethics Committee (IRB/IEC) - Process of ethical approval - Informed consent Regulatory Affairs & Marketing Approval - Drugs and Cosmetics Act 1940 - Drugs and Cosmetics Rules 1945 - Drugs and Cosmetics Rules 1945 Schedule Y - Basic process for achieving marketing approval/regulatory affairs Process of Conducting A Clinical Trial - Pre study organization - Investigator's responsibilities - Initiation and conduct - Site-activities and site-management - Drug accountability - Data handling/data management - Monitoring and source data verification - Safety reporting and adverse events - Audit and inspections - Close-out - Report writing General Management Skills - Communication - verbal/non-verbal, written - Art of presentation - Image management - Information management - Personality enhancement