Course Description

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. 

Learning Objectives

• Summarize Good Clinical Practice (GCP)
• Identify 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.

Instructor

The course will be led by one of the following instructors:

Lily Romero, P.A. C.C.R.C.

Elizabeth Weeks-Rowe, LVN, C.C.R.A.

Click here for complete trainer biographies

Course Outline

Day One

• 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 

• Root Cause Analysis & Corrective and Preventive Actions for Quality Management
• Compliance, Audits, Inspections & Conclusions  

Registration Fees

Accreditation Information

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#: 0778-0000-22-003-L04-P. Released: 3/22.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.