Program Overview
This program provides an in-depth understanding of Good Clinical Practice (GCP), focusing on the ethical, operational, and regulatory requirements that govern clinical trials. Participants will explore roles and responsibilities, study protocols, informed consent, data management, and quality assurance within clinical trials. The course features real-life case studies, interactive exercises, and expert insights, enabling participants to resolve real-world challenges and enhance GCP compliance and operational effectiveness.
Features
- Understand the fundamentals and key elements of Good Clinical Practice (GCP).
- Identify roles and responsibilities of stakeholders in clinical trials.
- Apply practical solutions to common challenges in GCP compliance.
- Improve trial quality, data integrity, and audit-readiness through actionable insights.
Target audiences
- Professionals involved in clinical trials, including clinical research associates, regulatory teams, quality assurance personnel, and project managers.
Curriculum
- 4 Sections
- 25 Lessons
- 1 Day
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- Introduction to Good Clinical Practice6
- 1.1Overview of GCP: Understanding the origins and evolution of GCP (ICH E6 Guidelines).
- 1.2Ethical considerations and the Declaration of Helsinki.
- 1.3Definitions: Subject, Sponsor, Investigator, CROs, and IRBs/IECs.
- 1.4Regulatory Framework: FDA, EMA, and local regulations.
- 1.5Understanding why GCP compliance is critical for trial success.
- 1.6Impact of non-compliance cases in clinical trials.
- Roles, Responsibilities, and Stakeholders in GCP7
- 2.1Sponsors, Monitors, and Investigators.
- 2.2Clinical Research Organizations (CROs) and their role in GCP.
- 2.3Institutional Review Boards (IRBs) and Ethics Committees.
- 2.4Investigator site practices and record-keeping.
- 2.5Safety reporting and adverse event management.
- 2.6Case Scenarios: How misalignment in roles can impact trial outcomes.
- 2.7Interactive Exercise: Role-based problem-solving exercise on stakeholder conflicts.
- GCP in Action - Managing Clinical Trial Processes8
- 3.1Study Protocol and Investigator’s Brochure.
- 3.2Informed Consent Process and Documentation.
- 3.3Source Data, Case Report Forms (CRFs), and Data Integrity.
- 3.4Audit Trails and Quality Assurance.
- 3.5Risk-Based Monitoring (RBM), Inspection Readiness, Data Privacy (GDPR), Good Documentation Practice (GDP).
- 3.6Best practices and challenges faced during trial audits.
- 3.7Situational case studies: Ensuring subject safety and data quality.
- 3.8Interactive Exercise: Audit Simulation – Identifying gaps in compliance in a mock trial scenario.
- Common Challenges and Real-World Problem Solving4
- 4.1Balancing timelines, costs, and compliance.
- 4.2Ensuring patient safety and ethical conduct in multi-center trials.
- 4.3Case Studies: Addressing protocol deviations; Managing data discrepancies; Ensuring consistent GCP adherence in global trials.
- 4.4Insights on handling regulatory inspections and deviations.
Instructor
