Fundamentals of Good Clinical Practice (GCP)
Sheila Austin, Registration Cost:
FREE and open for all to attend.Program Agenda:
- 12:00 PM – Registration & Networking
- 12:05 PM – Welcome and Introductions
- 12:10 PM – Educational Presentation
- 1:15 PM – Questions and Answers
- 1:25 PM - Closing remarks
A basic overview of FDA guidance and regulations that exist for conducting human subject research. A focus of ICH Guideline E6 (R2) will be specifically covered. Upon completion of this session, attendees should be able to:
- Review principles and regulatory requirements for Good Clinical Practice (GCP).
- Discuss roles and responsibilities of the Principal Investigator and study’s staff, protocol compliance, and other criteria for conducting clinical trials.
- Examine best practices, examples of GCP noncompliance, and corrective actions for protocol or procedural deviations.
- Discuss compliance scenarios related to regulatory and protocol compliance.
Researcher Professionals involved in human subject research at UF Health and around North Central FloridaContact hours:
1.5 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 registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate. Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
No refunds unless the event is cancelled by the chapter.Level:
Contact Alie Trainor, MPH, CPH, CCRC firstname.lastname@example.org
ACRP NCFL Chapter President