Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
Global GCP Monitoring: Domestic and International Compliance
Upcoming Courses
This course examines global GCP compliance issues and GCP monitoring responsibilities. Participants explore GCP issues relevant to studies conducted within the US and abroad. There is a special focus on the culture issues impacting clinical research.
- Describe FDA Good Clinical Practice in relation to clinical research
- Define ICH Good Clinical Practice E6 in relation to clinical research
- Discuss the European Union Directive and GCP
- Review other selected countries monitoring bodies and responsibilities
- Assess the cultural impacts on monitoring responsibilities OUS
- Clinical Research Associates
- Clinical Research Assistants
- Clinical Research Coordinators
- Principal and Sub-Investigators
- Quality Assurance and Other Regulatory Professionals
The course will be led by one of the following instructors:
Elizabeth Ronk Nelson, M.P.H.
Lily Romero, P.A., C.C.R.C.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction and Welcome
- Ethics in Clinical Research – An Overview
- FDA GCP
- ICH GCP E6
- European Union Directive and GCP
- Summary and Q&A
Day 2: 8:30 a.m. – 5:00 p.m.
- Specific Country Regulatory Bodies
- Culture Impacts on GCP
- GCP Exercises
- Wrap-up and Course Evaluation
- Shared Participants’ Good Monitoring Practices
- Examination of Real Life Scenarios
- Review of FDA Q&A Information Sheet
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
Click here for our seminar cancellation policy
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-13-033-L01-P. Released: 10/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
