CLINICAL SITE MANAGEMENT COURSE

Investigational Drug Development

• Historical Background
• Definitions and key terms
• Organization of clinical trial
• Phases of clinical trial
• Concepts of IND, NDA, and Pharmaco-vigilance

Ethics and Human Subjects Protection

• Development of ethical concepts
• Helsinki Declaration
• Belmont Report
• GCP-ICH Guidelines: Overview
• Role of Institutional Review Board
• Informed Consent

Pre-Study: Site Selection and Preparation

• Investigator Selection
• Responsibilities of investigator, CRC, monitor and CRO
• Initial visit by Sponsor Monitor
• Biohazard shipment training
• Staff training for the study
• Protocol Training

Study Conduct-1: Site Initiation

• Patient recruitment
• Patient screening
• IVR System
• Source documents
• Study visit schedules
• Informed Consent Administration

Study Conduct-2: Enrollment & Maintenance

• Randomization (Drug administration)
• Patient Maintenance
• Study medication accountability
• Adverse events
• Quality Assurance monitoring
• Concomitant medications
• Study products shipment

Study Conduct-3: Data Collection

• Electronic Data Capture (EDC)
• Case Report Forms Data Entry
• Study File Maintenance
• Study logs, reports and correspondence
• Source Documents Maintenance

Study Conduct-4: Drug Side and Adverse Effects

• Concomitant medications
• Diagnoses of AE and SAE
• Documentation and Reporting of SAE

Study Conduct-5: Study Close-Out

• Inventory of Study Medication
• Monitor close-out visit
• Documentation and Reporting of SAE (up to 30 days)
• IND reports and queries Resolution
• Final Reports

Regulatory Affairs: FDA and IRB Compliance

• FDA guidelines for inspections
• Inspection reports and classification
• Disqualification and Penalties
• IRB interim and final reports
• SAE reports to FDA and IRB
• QA visit

Investigational New Drug Exemption

• Federal Regulation (21 CFR Parts 50, 312, 812)
• General definitions and concepts
• Handling and shipment of devices
• FDA and IRB Requirements