Event Calendar

Agenda

Clinical Research Monitoring and GCP Workshop for Monitors, Site Coordinators and Auditors

For a printable PDF agenda, click here.

Day 1


7:45-8:00am Registration and Continental Breakfast (provided)

8:00-8:45am Welcome and Expectations

  • What is "good clinical practice"
  • The "spirit" of the conference
  • Great change in the Industry
  • Pharma Industry overview/drug approval process

8:45-9:45am Good Clinical Practice: Obligations of the Sponsor and Monitor

  • Basic Principals
  • International Conference on Harmonization
  • Investigator's Responsibilities
  • Monitor's Responsibilities
  • Company SOPs
  • Record Retention

 9:45-10:00am Break

 10:00-11:00am Ethical Considerations

  • Institutional Review Boards
  • Informed Consents
  • Financial Disclosure

 11:00-12:00pm Investigator Recruitment and Selection

  • Investigator Recruitment
  • Potential Investigative Sites
  • Investigator Selection Factors
  • Site Selection Visits

 12:00-1:00pm Lunch (provided)

 1:00-2:45pm Study Start-Up and Site Initiation Activities

  • Budget / Contract Negotiations
  • Essential Documents
  • Site Initiation
  • Subject Recruitment Planning

 2:45-3:00pm Break

 3:00-5:00pm Monitoring Activities and Site Visits

  • Purpose
  • Preparation
  • On-site Document Review
  • Visit Summary with Study Personnel
  • Visit Report and Follow-up
  • Monitoring Activities

Day 2


8:15-8:30am Continental Breakfast (provided)

8:30-10:00am Monitoring Activities and Site Visits (continued)

  • Case Studies
  • Exercises

10:00-10:15am Break

10:15-12:00pm Risk Based Monitoring

  • Budget and Contacts - The Basics
  • Essential Documents
  • Site Initiation
  • Subject Recruitment Planning

 12:00-1:00pm Lunch

 1:00-2:15pm Quality Assurance Audit

  • Difference between Auditing and Monitoring
  • Sponsor Audits
  • Preparing for an Audit
  • FDA Inspections
  • FDA Warning Letters
  • QA Exercise

 2:15-2:30pm Break

 2:30-4:30pm Case Studies