Applied Good Clinical Practices (GCP) Course

Applied Good Clinical Practices (GCP) Course is organized by Pharmaceutical Education and Research Institute (PERI).

Access: 4-Month

Description:
This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH.

You should expect to spend approximately 15 hours of study time to complete the course.

Educational Objectives:

• Interpret FDA regulations and International Conference on Harmonization (ICH) guidelines pertaining to GCPs.
• Identify the regulatory, source documentation, and recordkeeping requirements for clinical trials.
• Describe the components of internal auditing systems.
• Explain the roles and responsibilities of sponsor, monitor, investigator, and regulatory authorities in ensuring the proper conduct of clinical trials.
• Apply GCP principles to the collection and reporting of adverse events.

Key Topics

• Regulatory Environment in the US
• International GCP Regulations
• Institutional Review Board (IRB)/Ethics Committee Responsibilities
• Investigator Responsibilities
• Sponsor Responsibilities
• The Protocol
• Sponsor Obligations
• Monitoring Responsibilitie
• • • Clinical Quality Assurance (CQA) Group
• FDA Inspections
• Managing FDA Inspections.