Event Calendar

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)