SITE MANAGEMENT FOR INVESTIGATOR

Drug Development

• Definitions and Background
• Pharmacokinetics & Pharmacodynamics
• Phases and Concepts of IND and NDA
• Subject Populations (Pediatric, adult, aged and WOCBP)

Human Subjects Protection

• Development of Ethical Concepts
• Helsinki Declaration
• Belmont Report
• Role of FDA
• Role of Institutional Review Board
• Informed Consent Elements

ICH Guidelines

• Organizational Structure
• Classification and Implementation Steps
• Safety
• Efficacy
• Multi-Disciplinary Factors
• Common Technical Documents (CTD)
• Future Implementation Plans

GCP Guidelines

• Introduction
• FDA and Code of Federal Regulations (CFR)
• Comparison between ICH and GCP
• Safety of human subjects
• Efficacy of drug
• Safety of drug: Adverse Events
• Documentation Strategies

Role and Responsibilities of Clinical Investigator

• Investigator Participation (FDA-1572)
• Financial Declaration (FDA-3454)
• Staff Assignment and training
• Privacy of Medical Information Training
• Contracts and Budgetary Issues
• Study Protocol Training

Clinical Study Management

• Patient recruitment
• Patient screening
• Informed Consent Administration
• Randomization and Drug Titration
• Patient Maintenance and data collection

Investigational Drug

• Drug Storage and Administration
• Concomitant Medications Side Effects
• Breaking the Blinding Code
• Controlled Substances

Data Collection and Documentation

• Organized data collection and tracking
• Case Report Forms
• Study File Supervision
• Source Documents Maintenance
• Regulatory Records
• Queries Supervision

Drug Adverse Events

• Adverse Events Diagnoses
• Differences between AE and SAE
• Documentation and Reporting of SAE

Investigational Device

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