Good Clinical Practice (GCP) Compliance Program
$ 150
Equips participants with a comprehensive understanding of Good Clinical Practice principles and requirements for the ethical conduct of clinical trials based on ICH E6(R2).
Course Description
This program equips participants with a comprehensive understanding of Good Clinical Practice principles and requirements for the ethical conduct of clinical trials. Based on ICH E6(R2) guidelines, participants learn to protect trial participants, ensure data integrity, and meet regulatory requirements.
Program Modules
- Introduction to GCP: History, ICH E6(R2) & Regulatory Landscape
- Ethics in Clinical Research: Informed Consent, IRB/IEC & Ethical Principles
- Investigator Responsibilities: Protocol Adherence & Subject Safety
- Sponsor Responsibilities: Monitoring, Auditing & Regulatory Submissions
- Clinical Trial Documentation: TMF, Case Report Forms & Data Management
- Adverse Event Reporting: SAEs, SUSARs & Regulatory Notifications
- Investigational Product Management: Storage, Accountability & Reconciliation
- GCP Inspections, Non-Compliance & Corrective Action Strategies
Who Should Attend
Clinical research coordinators, principal investigators, research nurses, data managers, regulatory affairs professionals, and institutional review board members involved in clinical trials.
Course Details
- Duration: 4 Days
- Investment: $150 per participant