This course is designed as a ‘high level’ overview of Good Clinical Practices that provides attendees with the knowledge and understanding of Good Clinical Practices (GCP) for clinical research conducted under the US Code of Federal Regulations (CFR). ICH E-6 Good Clinical Practices Guidelines are also discussed.

Audience

This course is attended as an introductory course to Good Clinical Practices (GCP) for employees new to the product development industry (e.g. executives, administrative staff, GMP staff, business development, clinical development staff, etc.). This course is also delivered to our clients to meet their company requirements for Annual GCP Training.

Through lectures, activities, exercises, and multi-media tools, attendees begin to learn how to apply the GCP regulations.

Faculty:
Liz Wool, RN, BSN, CCRA, CMT
President
Association of Clinical Research Professionals (ACRP)
Northern California Chapter
President and CEO, QD-Quality and Training Solutions, Inc.™

Duration: 8 hours (1 day)

Course Objectives

• Explain the historical background of clinical research and GCP.
• Identify the regulations, standards and requirements for GCP.
• Understand the sponsor obligations for the conduct of clinical research.
• Describe Good Documentation Practices.

Course Outline

• Introduction
• Overview of Good Clinical Practice
• Overview: Food and Drug Administration (FDA) Office of Good Clinical Practices
• Good Clinical Practice: Historical Overview
• Sponsor/Investigator Responsibilities– Drugs/Biologics (21 CFR Part 312)
• Human Subject Protection (21 CFR Part 50), Informed Consent Process
• Institutional Review Boards (21 CFR Part 56)
• ICH E-6 Good Clinical Practices
• Ethics and Conflict of Interest in Clinical Research
• Financial Disclosure Requirements: Clinical Investigators (21 CFR Part 54)
• Good Documentation Practices
• Electronic Records and Electronic Signatures (21 CFR Part 11)
• Wrap-Up

To meet and maximize the learning needs of the attendees, the attendees will participate in choosing the activities/case studies to utilize during the class from our repertoire:

• CRO Oversight: Scope, Responsibilities and Documentation
• ICH-E6 GCP Guidelines to US CFR: Comparison and Contrast
• Informed Consent Checklist Review to an Informed Consent Form (Mock Exercise)
• Financial Disclosure Form and FDA 1572 Review (Mock Exercise)
• IRB Warning Letter and FDA Form 483 Review: Central IRB and Academic Institution IRB (FDA generated documents)
• Conflict of Interest in Clinical Research: Case Studies (Actual events reported)
• SAE Word Exercise

* Due to the short duration of this GCP overview class, 2 activities can be performed in a one-day course *

Registration

• Contact Us to bring this course to your organization.