Investigator Oversight and Engagement: Creating a Culture of Oversight
Please click here to purchase your contact hour.
Speaker Name:
- Bridget Gonzales, CCRC, Director, Training and Professional Development, ACRP
Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Project Managers
- Regulatory Affairs/Compliance
- Data Managers (Site, Sponsor, CRO)
- Medical Monitor, Medical Officer, Project Physician
- Quality Assurance
- Clinical Research Administrators
Program Description:Based on the FDA Guidance for Industry: Investigator Responsibilities- Protecting the Rights, Safety, and Welfare of Study Subjects, the presenter will review the guidance document and discuss ideas of creating a culture of awareness in promoting Investigator oversight and engagement at the clinical research site. The session is intended for all clinical research site professionals including Investigators.
Program Agenda12:00 - 1:00 PM: Educational Presentation
Learning Objectives:
- Review the suggested plan for the supervision and oversight of a clinical trial at a site based on the Guidance for Industry: Investigator Responsibilities document
- Discuss 3 specific elements of the suggested plan
- Describe ideas for promoting a culture of oversight within the 3 specific elements
Contact hours: 1.0 Contact hours have been applied for through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Registration Cost: FREE to all Chapter Members, ACRP Members, Non-Members
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Not applicable