Barnett International's Core Curriculum courses are comprehensive role-based training programs designed to provide participants with hands-on, in-person training. Held four times a year during Barnett’s “Clinical Research Training Weeks,” courses take place at state-of-the-art corporate meeting centers or in centrally located hotels on the East and West Coasts of the U.S., and offer focused, performance-based training and employee development.
Conducting Clinical Trials Under ICH GCP E6
This course offering will take place live via WebEx from 12:00 PM – 7:00 PM Eastern each day. Participants will receive an email confirmation that includes the seminar link to enter the meeting room as well as the audio connection information.
This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining an ongoing relationship with the FDA will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for their clinical studies. The R2 changes are covered in this course.
- Summarize Good Clinical Practice (GCP) Clinical Research Team Roles and Responsibilities
- Recognize how GCP impacts the clinical research process through review of key documents and necessary information for clinical trials
- Apply concepts of root cause analysis and corrective and preventive actions for quality management
- Discuss key elements for monitoring reports and written documentation in GCP
- Review regulatory compliance, audit preparation and inspections
Who Should Attend
- This course is intended for Clinical, Regulatory, and Quality Personnel who require an understanding of the GCP regulations and requirements. This course will also benefit other personnel who must be familiar with the essentials of the clinical process and requirements.
The course will be led by one of the following instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.
Elizabeth Ronk Nelson, M.P.H.
Lily Romero, P.A. C.C.R.C.
Day One: 8:30 a.m. – 5:00 p.m.
- Introduction to ICH and FDA GCPs: History; law; regulations; definitions; FDA organization; bioresearch monitoring group; evolution of GCP; ICH process
- Clinical Research Team Roles and Responsibilities: Sponsor, Investigator and IRB responsibility
- Informed Consent and Essential Documents: Elements of the Informed Consent, Essential Documentation Responsibilities of Sponsor and Investigator
Day Two: 8:30 a.m. – 5:00 p.m.
- Root Cause Analysis & Corrective and Preventive Actions for Quality Management
- Compliance, Audits, Inspections & Conclusions
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.
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#: 0778-0000-19-036-L01-P. Released: 9/19.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.