Members in Industry NetWork

Presentation Slides

View presentation slides from the CHEST 2006 Members in Industry NetWork postgraduate course: Participating in Industry-Sponsored Pulmonary and Critical Care Trials.

Process of Drug Development:

• Overview of Phase I to Phase IV
  Steven Kesten, MD, FCCP

• Clinical Trial Design Considerations
  George C. Georges, MD, FCCP

• Basic Statistical Issues in Clinical Trials
  Shailendra Menjage, PhD

• Development and Key Differences From Drug Development
  Arthur H. Combs, MD, FCCP

Setting Up a Clinical Investigational Site:

• Setting Up a Clinical Investigational Site
  Kate Didio, RN, MBA

• Conducting Research According to Good Clinical Practices
  Mark D. Williams, MD, FCCP

• Institutional Review Boards and Informed Consents
• Training Clinical Research Coordinators
  Diane L. Kachel

• Safety Reporting
  Dawn M. Carlson, MD, FCCP

Participation in a Clinical Trial

• Regulatory Documents
  George C. Georges, MD, FCCP

• Working with Clinical Trial Research Associates
• Case Report Forms
  Kate Didio, RN, MBA

• Closing Out a Trial
  Mark D. Williams, MD, FCCP

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