Essentials of Good Clinical Practice

Overview

This course will cover the process of new product development from bench to bedside and will introduce the essentials of Good Clinical Practice (GCP). GCP refers to a set of international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involved human subjects. GCP compliance ensures the protection of the rights, safety and well-being of trial subjects as well as the credibility and integrity of clinical trial data. This course will help participants acquire the fundamental skills required to set up and conduct clinical trials. It is designed to be an interactive learning experience combining analysis and explanation of selected portion of the Code of Federal Regulations (CFR) that are applicable to clinical research during new drug development. Because the drug development industry translates federal regulations as written and unwritten standards, practices and guidelines, this course uses case studies, workshops and group discussions to expand the interpretation beyond the broad definitions covered in the CFR.

Who will benefit

This course will be beneficial to those who are new to clinical research or those that are experienced in clinical research but have limited experience with GCP such as clinical research associates, compliance and quality team members, study coordinators and principal investigators.

Key topics

• Documents in clinical drug development
• Evaluation of studies to select the best investigators
• Review of human subject protection requirement and informed consent process
• Initiation visit and routine monitoring
• Protocol compliance, source documents an case report forms
• Patient recruitment and accrual
• Regulatory documents and adverse experience reporting
• Management and documentation of site compliance issues
• Finalization and reporting of study results

Learning outcomes

• Review of the evolution of GCP and currently accepted standards and discussion of changing practices and regulations
• Ability to define major steps and phases in drug development
• Understanding of main regulations governing clinical research and other guidelines such as European Union Directive, Food and Drug Administration Code of Federal Regulations (FDA CFR), data privacy and the Health Insurance Portability and Accountability Act (HIPPA), and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• Consideration of legal, ethical and professional constraints on various clinical research processes such as management of informed consent, Institutional Review Boards (IRBs), financial disclosures and electronic signatures
• Identification of tools and techniques to successfully execute trials
• Examination of internal principles of ethical conduct and subject protection

Click here to learn more about bringing this course in-house.

The Latest

"This course provided a great overview and the right level of detail on all areas of vendor management.”

Megan Cisneros, Clinical Project Manager
AMAG Pharmaceuticals
on Managing Outsourced Clinical Trials