Agenda

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

Please note - All times are in Eastern Time Zone. Times are fluid and may vary depending on the level of interaction
Day 1 

11:00 am ET - Welcome and Expectations (1 CE)

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

12:00 pm ET - Good Clinical Practice: Obligations of the Sponsor and Monitor (1.25 CE)

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

 1:15 pm ET - Break

 1:30 pm ET - Ethical Considerations (1.5 CE)

  • Institutional Review Boards
  • Informed Consents
  • Financial Disclosure
 Day 2 

11:00 am ET - Investigator Recruitment and Selection (1.25 CE)

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

12:15 pm ET - Study Start-Up and Site Initiation Activities (1.5 CE) (1:00 pm - Break)

  • Essential Documents
  • Site Initiation
  • Subject Recruitment Planning

    2:00 pm ET - Monitoring Activities and Site Visits (1 CE) 

    • Purpose
    • Preparation
    • On-site Document Review
    • Visit Summary with Study Personnel
    • Visit Report and Follow-up
    • Monitoring Activities
      Day 3 

      11:00 am ET - Monitoring Activities and Site Visits (continued) (2 CE)

      • Case Studies
      • Exercises

        1:00 pm ET - Break

        1:15 pm ET - COVID-19 Response: Facilitating Remote Monitoring Access - HIPAA and Part 11 Considerations (1.75 CE)

        • HIPAA Privacy Rule
        • 21 CFR Part 11
        • Options to facilitate remote monitoring
         Day 4 


        11:00 am ET - Risk Based Monitoring (2.25 CE) 

        • 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

        1:15 pm - Break

        1:30 pm ET - Quality Assurance Audit (1 CE)

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

        2:30 pm ET - Case Studies (0.5)