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)

8:00-9:00 am - Welcome and Expectations

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

9:00 - 10-:15 am - 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

 10:15 - 10:30 am - Break

 10:30 - 11:45 am - Ethical Considerations

  • Institutional Review Boards
  • Informed Consents
  • Financial Disclosure

 11:45 - 12:45 pm - Lunch (provided)

 12:45 - 2:00 pm - Investigator Recruitment and Selection
  • Investigator Recruitment
  • Potential Investigative Sites
  • Investigator Selection Factors
  • Site Selection Visits

 2:00 - 3:45 pm - Study Start-Up and Site Initiation Activities (2:45 - 3:00 pm - Break) 

  • Essential Documents
  • Site Initiation
  • Subject Recruitment Planning

3:45 - 5:00 pm - 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 - 10:30 am - Monitoring Activities and Site Visits (continued)

  • Case Studies
  • Exercises

10:30 - 10:45 am - Break

10:45-12:00 pm - Risk Based Monitoring

 

  • Definition of risk based monitoring
  • Rationale for change to risk based monitoring
  • Implementation of risk based monitoring by Sponsors
  • Site strategies to navigate this change in monitoring process

12:00 - 1:00 pm - Lunch

1:00 - 2:00 pm - Risk Based Monitoring (continued)

2:00 - 3:00 pm - Quality Assurance Audit

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

 3:00 - 3:15 pm - Break

3:15 - 4:30 pm - Case Studies