Clinical Research Course Content

Clinical Research:

• Introduction to Clinical Research
• INDA, NDA, ANDA applications
• Types, Designs and Phases of Clinical Trials
• ICH GCP guidelines (ICH E6)
• Roles and Responsibilities of Investigator and CRA
• Roles and Responsibilities of Sponsor and CRC
• Contract Research Organizations-CRO
• Case Report Form and its Contents with live example
• Contents of protocol
• Explanation of Research protocol with live example
• Informed Consent Form
• Institutional Review boards(IRB)/IEC
• Participant safety and Adverse events reporting
• Safety definitions and reporting requirements
• Monitoring of Study at participating sites
• Source Data Verification
• Investigator's Brochure (IB)
• Standard operating procedures
• Essential documents
• Data Coding using Meddra and WHODD
• CRF Design Guidelines
• SAE/AE Reconciliation