Continental Breakfast & Registration

8:30 am - 8:45 am

Welcome and Introduction

8:45 am - 10:00 am

Session 1 — Regulatory Review

• The Authority of the FDA
• US Code of Federal Regulations and Guidelines
• The FDA Modernization Act of 1997
• Financial Disclosure
• Electronic Records; Electronic Signatures
• HIPAA

10:00 am - 10:30 am

Morning Break

Session 2 — Global Perspectives

• The History of the ICH
• ICH GCP: Consolidated Guideline (E6)
• International Trials
• Clinical Research in Canada

Session 3 — Informed Consent

• Ensuring Regulatory Compliance
• Monitoring Considerations
• Informed Consent Exercise

Session 4 — Protocol Design

• Protocol Development
• Statistics for Clinical Research Associates
• Principles of Case Report Form Development
• Electronic Data Capture

Continental Breakfast

8:45 am - 10:00 am

Session 5 — Managing The Investigator Selection

• Selecting Qualified Investigators
• Working with SMOs
• Planning for the Pre-investigation Visit
• Conducting a Pre-investigation Visit
• Evaluating Facilities and Equipment
• Evaluating Staffing and Capabilities
• Verification of Patient Estimates

10:00 am - 10:30 am

Morning Break

10:30 am - 12:00 pm

Session 6 — Study Budgets

• Overview
• Developing Study Budgets
• Negotiation Tips
• Budgeting Exercise — How to Calculate the Costs

12:00 pm - 1:00 pm

Lunch

Session 7 — CRA Communications

• Correspondence
• Reports
• Presentations and Meetings

Session 8 — FDA Inspections of Clinical Sites

• FDA Inspections
• Key Concepts
• The Inspection Process
• Inspection Classifications and Consequences
• Preparing for an Inspection