Biotech and Pharmaceutical companies conduct clinical trials to study the efficacy and safety before releasing the products to the market. This course provides a practical and thorough study of regulations that govern conduct of clinical research (GCP), the responsibilities of sponsors, ethic boards, CROs, investigators and monitors during the drug development and approval process. It includes knowledge of setting up and monitoring of clinical trials at investigational sites and a study of documentation inherent to the process, including protocols, case report forms (CRF), source documents, and informed consent forms. The course also includes Investigational New Drug (IND) and New Drug Application (NDA) procedures. This course is designed for training individuals to have a role in clinical trials. This is an interactive course including discussions on current clinical trials, case studies and student participation.

This course provides a practical and thorough study of regulations that govern conduct of clinical research (GCP), the responsibilities of sponsors, ethic boards, CROs, investigators and monitors during the drug development and approval process. It includes knowledge of setting up and monitoring of clinical trials at investigational sites and a study of documentation inherent to the process, including protocols, case report forms (CRF), source documents, and informed consent forms. The course also includes Investigational New Drug (IND) and New Drug Application (NDA) procedures. This course is designed for individuals to have a role in clinical trials.

Topics :

• Introduction to Phases of Clinical Trials, Phase I, II, III and IV.
• Introduction to the FDA, ICH and other clinical trials related information.
• The Principles of Good Clinical Practice (GCP).
• The procedures involved in Site Selection and Site Initiation and routine Monitoring Visits.
• The overview of the important documents needed during clinical trials.
• Case Report Forms (CRFs) and Source Documents (SDs) and their verification.
• The essential responsibilities of the Investigators, Monitors and the Sponsor
• Informed Consent Forms
• Case Report Forms
• Protocols

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