Post Graduate Certification in Clinical Research

All India Institute of Local Self-Government
In Ahmedabad and Bangalore

Price on request
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Important information

Description

People who complete the course can be Investigators, Clinical Research Associates, Clinical Data Managers, Clinical Research Officers, QC & QA Managers, Auditors etc

Important information
Venues

Where and when

Starts Location
On request
Ahmedabad
Barfiwala Bhavan Nr Bhavans College Khaanpur, 380007, Gujarat, India
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On request
Bangalore
Annexe Prasad Health Care, Harsha Complex, Hennur Cross,Hennur Main Road, Kalyan Nagar PO., 5600043, Karnataka, India
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Frequent Asked Questions

· Requirements

Eligibility of the course is * Graduates & Post-graduates in Medicine, Dentistry, Ayurveda, Homoeopathy (M.B.,B.S., M.D., M.S., B.D.S., M.D.S., D.N.B., B.A.M.S., B.H.M.S.) * Graduates & Post-graduates in Pharmaceutical Science (B.Pharm. M.Pharm.) * Graduates & Post-graduates in Biochemistry, Anatomy,Physiology, Pharmacology, Botany, Zoology (B.Sc., M.Sc.)

Course programme

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

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