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 to 12:00 pm ET - Welcome and Expectations, James Simmer (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 to 1:15 pm ET - Good Clinical Practice: Obligations of the Sponsor and Monitor, Gretchen Gall (1.25 CE)

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

 1:15 pm to 1:30 pm ET - Break

 1:30 pm to 3:00 pm ET - Ethical Considerations, Gretchen Gall (1.5 CE)

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

11:00 am to 12:15 pm ET - Investigator Recruitment and Selection, James Simmer (1.25 CE)

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

12:15 pm to 1:30 pm ET - Study Start-Up and Site Initiation Activities, James Simmer (1.25 CE) 

  • Essential Documents
  • Site Initiation
  • Subject Recruitment Planning

1:30 pm to 1:45 pm ET - Break

1:45 pm to 3:00 pm ET - Monitoring Activities and Site Visits, Gretchen Gall (1.25 CE) 

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

11:00 am to 1:15 pm ET - Monitoring Activities and Site Visits, Gretchen Gall (continued) (2.25 CE)

  • Case Studies
  • Exercises

1:15 pm to 1:30 pm ET - Break

1:30 pm to 3:00 pm ET - Facilitating Remote Monitoring: Access and HIPAA Considerations, James Simmer (1.5 CE)

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

11:00 am to 1:15 pm ET - Risk Based Monitoring, James Simmer (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 to 1:30 pm - Break

1:30 pm to 2:30 pm ET - Quality Assurance Audit, Gretchen Gall (1 CE)

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

2:30 pm to 3:00 pm ET - Case Studies, James Simmer and Gretchen Gall (0.5)