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)

 8:00-9:45am               Good Clinical Practice: Obligations of the Sponsor and Monitor

  • Basic Principles
  • International Conference on Harmonisation
  • Investigator’s Responsibilities
  • Sponsor’s Responsibilities
  • Monitor’s Responsibilities
  • Record Retention
  • Basic Requirements for Conducting Studies in Canada

 9:45-10:00am            Break

10:00-11:00am           Investigator Recruitment and Selection: What is the Sponsor Looking For?

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

 11:00-12:00pm           Ethical Considerations

  • Institutional Review Boards
  • Financial Disclosure

12:00-1:00pm              Lunch (provided)

1:00-2:00pm                 Ιnformed Consent

  • This session will review the informed consent process, including discussion of requirements in the FDA regulations and the ICH E6 guideline, and some fo the challenges in obtaining informed consent.

2:00-3:00pm                Study Initiation Activities

  • Budget/Contract Negotiation
  • Essential Document Definitions and Collection Mechanisms

3:00-3:15pm                 Break

3:15 – 5:00                    Monitoring Activities and Site Visits

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

 


Day 2

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

8:00-10:00am                Monitoring Activities and Site Visits CONTINUED

10:00-10:15am              Break

10:15-11:15 am              The Quality Assurance Audit – Audit Preparedness

  • Distinguishing Auditing from Monitoring
  • Sponsor Audits
  • Getting Ready for an Audit
  • FDA Inspections

11:15am-12:00pm         Quality Assurance Exercise

12:00 -12:15 pm              FDA Warning Letters

12:15-1:15pm                  Lunch

1:15-2:30pm                    Completion and Discussion of Exercise

2:30-2:45pm                    Break

2:45-3:45pm                    Proactive Study Management

  • Expecting the Unexpected
  • Addressing Specific Challenges
  • Improving Performance

3:45-5:00pm                     Risk Based Monitoring 

  • Concepts of risk-based monitoring (RBM)
  • Potential risks and how they might be mitigated  
  • Options for monitoring of investigators and study oversight by sponsors